TY - JOUR AU - Hess, W. Courtney AU - Rosenbloom, N. Brittany AU - Mesaroli, Giulia AU - Lopez, Cristal AU - Ngo, Nhat AU - Cohen, Estreya AU - Ouellette, Carley AU - Gold, I. Jeffrey AU - Logan, Deirdre AU - Simons, E. Laura AU - Stinson, N. Jennifer PY - 2025/4/7 TI - Extended Reality (XR) in Pediatric Acute and Chronic Pain: Systematic Review and Evidence Gap Map JO - JMIR Pediatr Parent SP - e63854 VL - 8 KW - virtual reality KW - augmented reality KW - extended reality KW - acute pain KW - chronic pain KW - pediatrics KW - adolescents KW - safety KW - feasibility KW - effectiveness KW - evidence gap map KW - child KW - children KW - VR KW - XR KW - biobehavioral KW - intervention KW - systematic review N2 - Background: The use of extended reality (XR), including virtual reality (VR) and augmented reality (AR), for treating pain has accelerated in the last 10 years. XR is an attractive biobehavioral intervention that may support management of pain or pain-related disability. Reviews of the literature pertaining to adults report promising results, particularly for acute procedural pain. Objective: This study aimed to (1) summarize the available evidence with respect to feasibility, safety, and effectiveness (pain intensity) of XR for pediatric acute and chronic pain; (2) summarize assessment tools used to measure study outcomes; and (3) identify gaps in evidence to guide future research efforts. Methods: This study is a systematic review of the literature. Multiple databases (CINAHL, Cochrane Central, Embase, MEDLINE, PsycINFO) were searched from inception until March 2023. Titles, abstracts, and full-text articles were reviewed by 2 team members to determine eligibility. Articles were included if the (1) participants were aged 0 to 18 years; (2) study intervention was VR or AR; (3) study outcomes included safety, feasibility, acceptability, or effectiveness on the outcome of pain; and (4) study design was observational or interventional. Data were collected on bibliographic information; study characteristics; XR characteristics; outcome domains; outcome measures; and study findings pertaining to safety, feasibility, and effectiveness. Results: We included 90 articles in the review. All included studies used VR, and 93% (84/90) studied VR in the context of acute pain. Of the 90 studies, 74 studies were randomized trials, and 15 studies were observational. Safety was assessed in 23 studies of acute pain, with 13 studies reporting no adverse events and 10 studies reporting events of low concern. Feasibility was assessed in 27 studies. Of the 84 studies of acute pain, 62% (52/84) reported a positive effect on pain intensity, 21% (18/84) reported no effect, and 13% (11/84) reported mixed effects. All 6 studies of chronic pain reported a positive effect on pain intensity. An evidence gap map was used to illuminate gaps in specific research areas stratified by subtypes of pain. Risk of bias assessment revealed 67 studies had a moderate risk of bias, 17 studies had a high risk, and 5 studies were deemed to be low risk. Conclusions: The current body of literature around XR for pediatric pain is focused on acute pain with promising results of safety and effectiveness on pain intensity. The literature pertaining to chronic pain lags behind, limiting our ability to draw conclusions. The risk of bias in studies is problematic in this field, with the inherent challenge of blinding participants and researchers to the intervention. Future research should aim to measure effectiveness beyond pain intensity with a consistent approach to measuring key outcome domains and measures. Current efforts are underway to establish expert consensus on best research practices in this field. Trial Registration: Prospero CRD42022307153; https://www.crd.york.ac.uk/PROSPERO/view/CRD42022307153 UR - https://pediatrics.jmir.org/2025/1/e63854 UR - http://dx.doi.org/10.2196/63854 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/63854 ER - TY - JOUR AU - Liszio, Stefan AU - Bäuerlein, Franziska AU - Hildebrand, Jens AU - van Nahl, Carolin AU - Masuch, Maic AU - Basu, Oliver PY - 2025/3/31 TI - Cooperative Virtual Reality Gaming for Anxiety and Pain Reduction in Pediatric Patients and Their Caregivers During Painful Medical Procedures: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e63098 VL - 14 KW - virtual reality KW - extended reality KW - mixed reality KW - serious game KW - video game KW - pain KW - anxiety KW - stress KW - child KW - caregiver KW - patient experience KW - well-being KW - medical procedures KW - punctures KW - distraction KW - intervention N2 - Background: The hospital experience is often marked by fear and pain, particularly for children undergoing medical procedures. Sedation is commonly used to alleviate patient anxiety, but it poses additional health risks. Caregivers, usually the parents, also experience emotional distress during the child?s hospital stay, which can further exacerbate the child?s anxiety and pain. While various interventions exist to ease patient distress, few consider the emotional well-being of caregivers. Objective: This study aims to explore the effectiveness of a cooperative virtual reality (VR) game as a novel nonpharmacological solution to reduce anxiety and pain for both pediatric patients and their caregivers during medical procedures. Specifically, we aim to investigate whether the VR game ?Sweet Dive VR? (SDVR), designed for children aged between 6 and 12 years to play with 1 caregiver, can alleviate anxiety and pain during different types of needle punctures and Kirschner-wire removal. Methods: A prospective multicenter randomized clinical trial will be conducted. Eligible participants will be identified by scanning the hospital information system, and group allocation will follow stratified randomization. During the medical procedure, patients in the VR condition will play SDVR with a caregiver present, while patients in the control group will listen to a recording of gently crashing waves. Data collection will be carried out through self-reports of patients and caregivers using visual analog scales and questionnaires at 2 measurement time points: before and after the intervention. In addition, observation by the interviewers will occur during the intervention to capture emotional and pain reactions as well as interaction quality between patients and caregivers and smoothness of the procedure flow using a structured observation protocol. The measured variables will encompass patient affect and pain, caregiver affect, player experience, patient experience, and the flow of the procedure. Results: As of November 2024, we enrolled 39 patients and caregivers, 28 of whom completed the study. Data collection is still ongoing. Conclusions: Cooperative VR gaming, as exemplified by SDVR, emerges as a promising intervention to address anxiety and pain in pediatric patients while involving caregivers to support the emotional well-being of both parties. Our approach strives to foster positive shared experiences and to maintain trust between children and caregivers during emotionally challenging medical situations. Trial Registration: German Clinical Trial Register (DRKS) DRKS00033544; https://drks.de/search/en/trial/DRKS00033544 International Registered Report Identifier (IRRID): DERR1-10.2196/63098 UR - https://www.researchprotocols.org/2025/1/e63098 UR - http://dx.doi.org/10.2196/63098 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/63098 ER - TY - JOUR AU - Edwards, A. Karlyn AU - Dildine, C. Troy AU - You, S. Dokyoung AU - Herrick, M. Ashley AU - Darnall, D. Beth AU - Mackey, C. Sean AU - Ziadni, S. Maisa PY - 2025/3/11 TI - Zoom-Delivered Empowered Relief for Chronic Pain: Observational Longitudinal Pilot Study Exploring Feasibility and Pain-Related Outcomes in Patients on Long-Term Opioids JO - JMIR Form Res SP - e68292 VL - 9 KW - Empowered Relief KW - single session KW - chronic pain KW - prescription opioids KW - telehealth KW - daily data KW - pain intensity KW - pain catastrophizing N2 - Background: Patients with chronic pain on long-term opioid therapy often face barriers to accessing effective nonpharmacological treatments, including the burden of multiple sessions, lack of trained clinicians, and travel time. Empowered Relief (ER), a 2-hour, single-session pain relief skills class, can improve pain and quality of life among patients with chronic pain when delivered in person or virtually. Objective: This study examined the impact of Zoom-delivered ER among people with chronic pain on long-term opioid therapy. We assessed (1) the feasibility and acceptability of Zoom-delivered ER; (2) changes in pain and opioid use outcomes at 3 and 6 months after treatment; and (3) daily associations among pain, opioid dose, and the Pain Catastrophizing Scale (PCS) before and after treatment. Methods: During the early COVID-19 pandemic, we conducted an uncontrolled pilot study of a Zoom-delivered ER among 60 adults (n=45, 76% female participants; n=52, 88% White participants) experiencing chronic pain who were receiving daily prescribed opioids (?10 morphine-equivalent daily dose). Participants completed assessments at enrollment, before class, after class, 3 months after treatment, and 6 months after treatment. Furthermore, participants completed 2 daily assessment periods (spanning 14 consecutive days) before and after the class. We used a multilevel modeling approach to examine (1) the raw changes in PCS, average pain intensity, pain interference, and self-reported opioid dose at 3 and 6 months after treatment and (2) daily-level changes in average pain intensity and opioid dose before and after the class. Results: Of the 60 participants enrolled, 41 (68%) attended the class and 24 (59% of the 41 class attendees) reported satisfaction with the Zoom-delivered class. PCS score was significantly reduced at 3 months (?=?3.49, P=.01; Cohen d=0.35) and 6 months after treatment (?=?3.61, P=.01; Cohen d=0.37), and pain intensity was significantly reduced at 3 months (?=?0.56, P=.01; Cohen d=0.39) compared to enrollment. There were no significant reductions in pain interference or opioid dose. Across daily assessments, higher daily pain catastrophizing was associated with worse daily pain (?=.42, P<.001) and higher self-reported opioid use (?=3.14, P<.001); daily pain intensity significantly reduced after the class (?=?.50, P<.001). People taking prescribed opioids as needed trended toward decreasing their daily opioid use after the class (?=?9.31, P=.02), although this result did not survive correction for multiplicity. Conclusions: Improvements to future Zoom-delivered ER iterations are needed to improve feasibility and acceptability among people with chronic pain and daily prescribed opioid use. Despite this, findings show a promising preliminary impact of the intervention on pain outcomes. A larger randomized controlled trial of Zoom-delivered ER among this patient population is currently under way. UR - https://formative.jmir.org/2025/1/e68292 UR - http://dx.doi.org/10.2196/68292 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/68292 ER - TY - JOUR AU - Francis, Karlee AU - Francis, Julie AU - Latimer, Margot AU - Gould, Hayley AU - Blackmore, Shante AU - MacLeod, Emily PY - 2025/3/3 TI - Development and Testing of the Kids Hurt App, a Web-Based, Pain Self-Report App for First Nations Youths: Mixed Methods Study JO - JMIR Hum Factors SP - e48370 VL - 12 KW - app KW - eHealth KW - pain KW - Indigenous KW - First Nations KW - children KW - youths KW - mobile phone N2 - Background: First Nations children and youths may have unique ways to convey their health needs that have not been recognized by health providers. This may contribute to the disparity between high rates of mental health and physical pain and low rates of treatment for the conditions they experience. Evidence suggests that a colonial history has resulted in poor experiences with the health care system, lack of trust with health providers, and miscommunication between clinicians and patients. Contemporary ways, using both Indigenous and Western knowledge, are needed to bridge the gap in communicating pain. Objective: The aim of this qualitative study was to test the usability and clinical feasibility of the Kids Hurt App with First Nations youths and clinicians working with youths. Methods: Using a Two-Eyed Seeing approach, the Kids Hurt App was developed using concepts from validated mood and pain assessment apps combined with community-based research that gathered First Nations youths and clinicians perspectives on quality, intensity, and location of pain and hurt. The Kids Hurt App contains 16 screens accessible on any web-based device. Results: In total, 3 rounds of low-fidelity testing (n=19), 2 rounds of high-fidelity testing (n=20), and 2 rounds of clinical feasibility testing (n=10) were conducted with First Nations youths (10?19 years) to determine the relevance, validity, and usability of the Kids Hurt App. High-fidelity testing was also conducted with 15 clinicians after completing the high-fidelity youth sessions. Youths had constructive suggestions that were used to improve the app in subsequent rounds of version testing. There was one main discrepancy between youths and clinicians related to preference for how best to visually convey pain. The youth?s preference was maintained in the app. Conclusions: All youths in all rounds of testing indicated that they would use the Kids Hurt App if it was available to them in a health care setting, with most clinicians noting that the app would be useful in practice. UR - https://humanfactors.jmir.org/2025/1/e48370 UR - http://dx.doi.org/10.2196/48370 ID - info:doi/10.2196/48370 ER - TY - JOUR AU - Sada, Fatos AU - Chivers, Paola AU - Cecelia, Sokol AU - Statovci, Sejdi AU - Ukperaj, Kujtim AU - Hughes, Jeffery AU - Hoti, Kreshnik PY - 2024/12/3 TI - Parental Assessment of Postsurgical Pain in Infants at Home Using Artificial Intelligence?Enabled and Observer-Based Tools: Construct Validity and Clinical Utility Evaluation Study JO - JMIR Pediatr Parent SP - e64669 VL - 7 KW - PainChek Infant KW - Observer-Administered Visual Analog Scale KW - parents KW - infant pain KW - pain assessment KW - circumcision KW - infant home assessment KW - clinical utility KW - construct validity KW - artificial intelligence N2 - Background: Pain assessment in the infant population is challenging owing to their inability to verbalize and hence self-report pain. Currently, there is a paucity of data on how parents identify and manage this pain at home using standardized pain assessment tools. Objective: This study aimed to explore parents? assessment and intervention of pain in their infants at home following same-day surgery, using standardized pain assessment tools. Methods: This prospective study initially recruited 109 infant boys undergoing circumcision (same-day surgery). To assess pain at home over 3 days after surgery, parents using iOS devices were assigned to use the PainChek Infant tool, which is a point-of-care artificial intelligence?enabled tool, while parents using Android devices were assigned to use the Observer-Administered Visual Analog Scale (ObsVAS) tool. Chi-square analysis compared the intervention undertaken and pain presence. Generalized estimating equations were used to evaluate outcomes related to construct validity and clinical utility. Receiver operating characteristic analysis assessed pain score cutoffs in relation to the intervention used. Results: A total of 69 parents completed postsurgery pain assessments at home and returned their pain diaries. Of these 69 parents, 24 used ObsVAS and 45 used PainChek Infant. Feeding alone and feeding with medication were the most common pain interventions. Pain presence over time reduced. In the presence of pain, an intervention was likely to be administered (?22=21.4; P<.001), with a medicinal intervention being 12.6 (95% CI 4.3-37.0; P<.001) times more likely and a nonmedicinal intervention being 5.2 (95% CI 1.8-14.6; P=.002) times more likely than no intervention. In the presence of intervention, score cutoff values were ?2 for PainChek Infant and ?20 for ObsVAS. A significant effect between the use of the pain instrument (?21=7.2, P=.007) and intervention (?22=43.4, P<.001) was found, supporting the construct validity of both instruments. Standardized pain scores were the highest when a medicinal intervention was undertaken (estimated marginal mean [EMM]=34.2%), followed by a nonmedicinal intervention (EMM=23.5%) and no intervention (EMM=11.2%). Similar trends were seen for both pain instruments. Pain was reduced in 94.5% (224/237) of assessments where parents undertook an intervention. In 75.1% (178/237) of assessments indicative of pain, the score changed from pain to no pain, with PainChek Infant assessments more likely to report this change (odds ratio 4.1, 95% CI 1.4-12.3) compared with ObsVAS assessments. Conclusions: The use of standardized pain assessment instruments by parents at home to assess pain in their infants can inform their decision-making regarding pain identification and management, including determining the effectiveness of the chosen intervention. In addition to the construct validity and clinical utility of PainChek Infant and ObsVAS in this setting, feeding alone and a combination of feeding with medication use were the key pain intervention strategies used by parents. UR - https://pediatrics.jmir.org/2024/1/e64669 UR - http://dx.doi.org/10.2196/64669 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/64669 ER - TY - JOUR AU - Orgil, Zandantsetseg AU - Karthic, Anitra AU - Bell, F. Nora AU - Heisterberg, M. Lisa AU - Williams, E. Sara AU - Ding, Lili AU - Kashikar-Zuck, Susmita AU - King, D. Christopher AU - Olbrecht, A. Vanessa PY - 2024/9/16 TI - Use of Biofeedback-Based Virtual Reality in Pediatric Perioperative and Postoperative Settings: Observational Study JO - JMIR Perioper Med SP - e48959 VL - 7 KW - virtual reality KW - biofeedback KW - biofeedback-based virtual reality KW - acute pain KW - postoperative pain KW - pediatrics KW - postoperative KW - pain KW - anxiety KW - children KW - adolescents KW - perioperative management KW - acceptability KW - feasibility KW - pain reduction N2 - Background: Biofeedback-based virtual reality (VR-BF) is a novel, nonpharmacologic method for teaching patients how to control their breathing, which in turn increases heart rate variability (HRV) and may reduce pain. Unlike traditional forms of biofeedback, VR-BF is delivered through a gamified virtual reality environment, increasing the accessibility of biofeedback. This is the first study to systematically integrate VR-BF use in the pediatric perioperative setting, with the ultimate goal of evaluating the efficacy of VR-BF to reduce pain, anxiety, and opioid consumption once feasibility and acceptability have been established. Objectives: The primary objective was to develop a clinical trial protocol for VR-BF use in the pediatric perioperative setting, including preoperative education and training, and postoperative application of VR-BF in children undergoing surgery. A secondary objective was to evaluate the patient and parent experience with VR-BF. Methods: A total of 23 patients (12-18 years of age) scheduled for surgery at Nationwide Children?s Hospital were recruited using purposive sampling. Following training, participants independently completed a daily, 10-minute VR-BF session for 7 days before surgery and during their inpatient stay. Participants could use VR-BF up to 2 weeks after hospital discharge. Patient- and session-level data of VR-BF usage and achievement of target HRV parameters were measured to identify the optimal frequency and duration of sessions before and after surgery for this population. Standardized questionnaires and semistructured interviews were conducted to obtain qualitative information about patients? experiences with VR-BF. Results: Patient-level data indicated that the highest odds of achieving 1 session under target HRV parameters was after 4 sessions (odds ratio [OR] 5.1 for 4 vs 3 sessions, 95% CI 1.3-20.6; OR 16.6 for 3 vs 2 sessions, 95% CI 1.2-217.0). Session-level data showed that a session duration of 9 to 10 minutes provided the greatest odds of achieving 1 session under target HRV parameters (OR 1.3 for 9 vs 8 min, 95% CI 1.1-1.7; OR 1.4 for 8 vs 7 min, 95% CI 1.1-1.8; OR 1 for 10 vs 9 min, 95% CI 0.9-1.2). Qualitative data revealed patient satisfaction with the VR-BF technology, particularly in managing perioperative stress (17/20, 85%). Few patients reported VR-BF as beneficial for pain (8/20, 40%). Conclusions: Children and adolescents undergoing surgery successfully learned behavioral strategies with VR-BF with 10-minute sessions once daily for 5 days. To integrate VR-BF as a therapeutic intervention in a subsequent clinical trial, patients will be instructed to complete three 10-minute sessions a day for 7 days after surgery. Trial Registration: ClinicalTrials NCT04943874; https://clinicaltrials.gov/ct2/show/NCT04943874 UR - https://periop.jmir.org/2024/1/e48959 UR - http://dx.doi.org/10.2196/48959 UR - http://www.ncbi.nlm.nih.gov/pubmed/38742940 ID - info:doi/10.2196/48959 ER - TY - JOUR AU - Gold, I. Jeffrey AU - Akbar, M. Krystal AU - Avila, Sandra AU - Ngo, H. Nhat AU - Klein, J. Margaret PY - 2024/7/1 TI - Exploring Relations Between Unique Patient Characteristics and Virtual Reality Immersion Level on Anxiety and Pain in Patients Undergoing Venipuncture: Secondary Analysis of a Randomized Control Trial JO - J Med Internet Res SP - e53196 VL - 26 KW - pediatrics KW - virtual reality KW - VR KW - immersion KW - anxiety KW - pain management KW - routine medical procedures KW - venipuncture KW - secondary data analysis KW - mediation KW - moderation KW - pain KW - acute pain KW - pediatric pain KW - anxiety sensitivity N2 - Background: Virtual reality (VR) is a well-researched digital intervention that has been used for managing acute pain and anxiety in pediatric patients undergoing various medical procedures. This study focuses on investigating the role of unique patient characteristics and VR immersion level on the effectiveness of VR for managing pediatric pain and anxiety during venipuncture. Objective: The purpose of this study is to determine how specific patient characteristics and level of immersion during a VR intervention impact anxiety and pain levels for pediatric patients undergoing venipuncture procedures. Methods: This study is a secondary data analysis of 2 combined, previously published randomized control trials on 252 pediatric patients aged 10-21 years observed at Children?s Hospital Los Angeles from April 12, 2017, to July 24, 2019. One randomized clinical trial was conducted in 3 clinical environments examining peripheral intravenous catheter placement (radiology and an infusion center) and blood draw (phlebotomy). Conditional process analysis was used to conduct moderation and mediation analyses to assess the impact of immersion level during the VR intervention. Results: Significant moderation was found between the level of immersion and anxiety sensitivity when predicting postprocedural anxiety (P=.01). Patients exhibiting the highest anxiety sensitivity within the standard of care yielded a 1.9 (95% CI 0.9-2.8; P<.001)-point elevation in postprocedural anxiety relative to individuals with high immersion levels. No other significant factors were found to mediate or moderate the effect of immersion on either postprocedural anxiety or pain. Conclusions: VR is most effective for patients with higher anxiety sensitivity who report feeling highly immersed. Age, location of the procedure, and gender of the patient were not found to significantly impact VR?s success in managing levels of postprocedural pain or anxiety, suggesting that immersive VR may be a beneficial intervention for a broad pediatric population. Trial Registration: ClinicalTrials.gov NCT04268901; https://clinicaltrials.gov/study/NCT04268901 UR - https://www.jmir.org/2024/1/e53196 UR - http://dx.doi.org/10.2196/53196 UR - http://www.ncbi.nlm.nih.gov/pubmed/38949862 ID - info:doi/10.2196/53196 ER - TY - JOUR AU - Gagnon, M. Michelle AU - Brilz, R. Alexandra AU - Alberts, M. Nicole AU - Gordon, L. Jennifer AU - Risling, L. Tracie AU - Stinson, N. Jennifer PY - 2024/4/8 TI - Understanding Adolescents? Experiences With Menstrual Pain to Inform the User-Centered Design of a Mindfulness-Based App: Mixed Methods Investigation Study JO - JMIR Pediatr Parent SP - e54658 VL - 7 KW - adolescent health KW - endometriosis KW - pain management, biopsychosocial KW - women?s health KW - dysmenorrhea KW - thematic analysis KW - mHealth KW - mobile health KW - app KW - apps KW - applications KW - attitude KW - attitudes KW - opinion KW - perception KW - perceptions KW - perspective KW - perspectives KW - interest KW - intent KW - intention KW - survey KW - surveys KW - focus group KW - focus groups KW - content analysis KW - mindfulness KW - meditation KW - menstrual KW - menstruation KW - experience KW - experiences KW - pain KW - youth KW - adolescent KW - adolescents KW - teen KW - teens KW - teenager KW - teenagers N2 - Background: Digital interventions are increasingly popular for the provision of nonpharmacological pain interventions, but few exist for adolescents with menstrual pain. User-centered design involves incorporating users across phases of digital health intervention design, development, and implementation and leads to improved user engagement and outcomes. A needs assessment is the first step of this approach. Objective: The goal of this study was to conduct a needs assessment to understand menstrual pain management needs and preferences and mindfulness experiences, preferences, and knowledge of adolescents with menstrual pain to inform the future development of an app for managing menstrual pain. Methods: We used an explanatory sequential mixed method design that included a survey followed by focus groups. Adolescents aged 13-17 years completed a survey (n=111) and participated in focus groups (n=16). Data were analyzed using descriptive statistics and thematic content analysis and synthesized to provide specific recommendations based on adolescent responses. Results: Adolescents (n=111) who completed the survey reported a moderate understanding of mindfulness and menstrual pain. Over three-quarters (n=87, 78%) of participants practiced some form of mindfulness and 87% (n=97) of survey participants used nonpharmacological pain management strategies. Teens had a moderate perception that mindfulness could help their menstrual pain (mean 4.51/10, SD 2.45, with higher scores suggesting more interest). Themes were generated related to mindfulness experiences, menstrual pain knowledge and experiences, and app functionality. These themes underscored adolescents? need for continued support and flexible access to mindfulness activities; their awareness of multiple influences to pain, with potential for further education in this area; and the need for menstrual pain?specific content, along with content relevant to typical day-to-day experiences of adolescents. Conclusions: Adolescents with menstrual pain have an interest in using a mindfulness app for pain but have unique needs that need to be addressed to ensure app engagement and relevance for this population. Concrete recommendations for future app development are provided. UR - https://pediatrics.jmir.org/2024/1/e54658 UR - http://dx.doi.org/10.2196/54658 UR - http://www.ncbi.nlm.nih.gov/pubmed/38587886 ID - info:doi/10.2196/54658 ER - TY - JOUR AU - Wood, D. Michael AU - West, C. Nicholas AU - Fokkens, Christina AU - Chen, Ying AU - Loftsgard, C. Kent AU - Cardinal, Krystal AU - Whyte, D. Simon AU - Portales-Casamar, Elodie AU - Görges, Matthias PY - 2023/11/17 TI - An Individualized Postoperative Pain Risk Communication Tool for Use in Pediatric Surgery: Co-Design and Usability Evaluation JO - JMIR Pediatr Parent SP - e46785 VL - 6 KW - eHealth KW - risk communication KW - decision aid KW - pain KW - individualized risk KW - surgery KW - anesthesia KW - postoperative KW - risk KW - co-design KW - focus group KW - requirement definition KW - prototyping KW - usability KW - prototype KW - child KW - pediatric KW - decision support KW - iterative N2 - Background: Risk identification and communication tools have the potential to improve health care by supporting clinician-patient or family discussion of treatment risks and benefits and helping patients make more informed decisions; however, they have yet to be tailored to pediatric surgery. User-centered design principles can help to ensure the successful development and uptake of health care tools. Objective: We aimed to develop and evaluate the usability of an easy-to-use tool to communicate a child?s risk of postoperative pain to improve informed and collaborative preoperative decision-making between clinicians and families. Methods: With research ethics board approval, we conducted web-based co-design sessions with clinicians and family participants (people with lived surgical experience and parents of children who had recently undergone a surgical or medical procedure) at a tertiary pediatric hospital. Qualitative data from these sessions were analyzed thematically using NVivo (Lumivero) to identify design requirements to inform the iterative redesign of an existing prototype. We then evaluated the usability of our final prototype in one-to-one sessions with a new group of participants, in which we measured mental workload with the National Aeronautics and Space Administration (NASA) Task Load Index (TLX) and user satisfaction with the Post-Study System Usability Questionnaire (PSSUQ). Results: A total of 12 participants (8 clinicians and 4 family participants) attended 5 co-design sessions. The 5 requirements were identified: (A) present risk severity descriptively and visually; (B) ensure appearance and navigation are user-friendly; (C) frame risk identification and mitigation strategies in positive terms; (D) categorize and describe risks clearly; and (E) emphasize collaboration and effective communication. A total of 12 new participants (7 clinicians and 5 family participants) completed a usability evaluation. Tasks were completed quickly (range 5-17 s) and accurately (range 11/12, 92% to 12/12, 100%), needing only 2 requests for assistance. The median (IQR) NASA TLX performance score of 78 (66-89) indicated that participants felt able to perform the required tasks, and an overall PSSUQ score of 2.1 (IQR 1.5-2.7) suggested acceptable user satisfaction with the tool. Conclusions: The key design requirements were identified, and that guided the prototype redesign, which was positively evaluated during usability testing. Implementing a personalized risk communication tool into pediatric surgery can enhance the care process and improve informed and collaborative presurgical preparation and decision-making between clinicians and families of pediatric patients. UR - https://pediatrics.jmir.org/2023/1/e46785 UR - http://dx.doi.org/10.2196/46785 UR - http://www.ncbi.nlm.nih.gov/pubmed/37976087 ID - info:doi/10.2196/46785 ER - TY - JOUR AU - Johansen, Kristoffer Simon AU - Kanstrup, Marie Anne AU - Haseli, Kian AU - Stenmo, Hildebrandt Visti AU - Thomsen, Laust Janus AU - Rathleff, Skovdal Michael PY - 2023/4/28 TI - Exploring User Visions for Modeling mHealth Apps Toward Supporting Patient-Parent-Clinician Collaboration and Shared Decision-making When Treating Adolescent Knee Pain in General Practice: Workshop Study JO - JMIR Hum Factors SP - e44462 VL - 10 KW - mobile health KW - mHealth KW - design KW - patient physician relationship KW - collaborative care KW - shared decision-making KW - adolescents KW - parents KW - knee pain KW - patellofemoral pain KW - Osgood Schlatter KW - musculoskeletal KW - general practice KW - primary care KW - mobile phone N2 - Background: Long-standing knee pain is one of the most common reasons for adolescents (aged 10-19 years) to consult general practice. Generally, 1 in 2 adolescents will continue to experience pain after 2 years, but exercises and self-management education can improve the prognosis. However, adherence to exercises and self-management education interventions remains poor. Mobile health (mHealth) apps have the potential for supporting adolescents? self-management, enhancing treatment adherence, and fostering patient-centered approaches. However, it remains unclear how mHealth apps should be designed to act as tools for supporting individual and collaborative management of adolescents? knee pain in a general practice setting. Objective: The aim of the study was to extract design principles for designing mHealth core features, which were both sufficiently robust to support adolescents? everyday management of their knee pain and sufficiently flexible to act as enablers for enhancing patient-parent collaboration and shared decision-making. Methods: Overall, 3 future workshops were conducted with young adults with chronic knee pain since adolescence, parents, and general practitioners (GPs). Each workshop followed similar procedures, using case vignettes and design cards to stimulate discussions, shared construction of knowledge and elicit visions for mHealth designs. Young adults and parents were recruited via social media posts targeting individuals in Northern Jutland. GPs were recruited via email and cold calling. Data were transcribed and analyzed thematically using NVivo (QSR International) coding software. Extracted themes were synthesized in a matrix to map tensions in the collaborative space and inform a conceptual model for designing mHealth core-features to support individual and collaborative management of knee pain. Results: Overall, 38% (9/24) young adults with chronic knee pain since adolescence, 25% (6/24) parents, and 38% (9/24) GPs participated in the workshops. Data analysis revealed how adolescents, parents, and clinicians took on different roles within the collaborative space, with different tasks, challenges, and information needs. In total, 5 themes were identified: adolescents as explorers of pain and social rules; parents as supporters, advocates and enforcers of boundaries; and GPs as guides, gatekeepers, and navigators or systemic constraints described participants? roles; collaborative barriers and tensions referred to the contextual elements; and visions for an mHealth app identified beneficial core features. The synthesis informed a conceptual model, outlining 3 principles for consolidating mHealth core features as enablers for supporting role negotiation, limiting collaborative tensions, and facilitating shared decision-making. Conclusions: An mHealth app for treating adolescents with knee pain should be designed to accommodate multiple users, enable them to shift between individual management decision-making, take charge, and engage in role negotiation to inform shared decision-making. We identified 3 silver-bullet principles for consolidating mHealth core features as enablers for negotiation by supporting patient-GP collaboration, supporting transitions, and cultivating the parent-GP alliance. UR - https://humanfactors.jmir.org/2023/1/e44462 UR - http://dx.doi.org/10.2196/44462 UR - http://www.ncbi.nlm.nih.gov/pubmed/37115609 ID - info:doi/10.2196/44462 ER - TY - JOUR AU - Schemer, Lea AU - Hess, W. Courtney AU - Van Orden, R. Amanda AU - Birnie, A. Kathryn AU - Harrison, E. Lauren AU - Glombiewski, A. Julia AU - Simons, E. Laura PY - 2023/3/9 TI - Enhancing Exposure Treatment for Youths With Chronic Pain: Co-design and Qualitative Approach JO - J Particip Med SP - e41292 VL - 15 KW - co-design KW - participatory design KW - pain KW - exposure treatment KW - youths with chronic pain KW - caregivers KW - qualitative analysis N2 - Background: Increasing the access to and improving the impact of pain treatments is of utmost importance, especially among youths with chronic pain. The engagement of patients as research partners (in contrast to research participants) provides valuable expertise to collaboratively improve treatment delivery. Objective: This study looked at a multidisciplinary exposure treatment for youths with chronic pain through the lens of patients and caregivers with the aim to explore and validate treatment change processes, prioritize and develop ideas for improvement, and identify particularly helpful treatment elements. Methods: Qualitative exit interviews were conducted with patients and caregivers at their discharge from 2 clinical trials (ClinicalTrials.gov NCT01974791 and NCT03699007). Six independent co-design meetings were held with patients and caregivers as research partners to establish a consensus within and between groups. The results were validated in a wrap-up meeting. Results: Patients and caregivers described that exposure treatment helped them better process pain-related emotions, feel empowered, and improve their relationship with each other. The research partners developed and agreed upon 12 ideas for improvement. Major recommendations include that pain exposure treatment should be disseminated more not only among patients and caregivers but also among primary care providers and the general public to facilitate an early referral for treatment. Exposure treatment should allow flexibility in terms of duration, frequency, and delivery mode. The research partners prioritized 13 helpful treatment elements. Most of the research partners agreed that future exposure treatments should continue to empower patients to choose meaningful exposure activities, break long-term goals into smaller steps, and discuss realistic expectations at discharge. Conclusions: The results of this study have the potential to contribute to the refinement of pain treatments more broadly. At their core, they suggest that pain treatments should be disseminated more, flexible, and transparent. UR - https://jopm.jmir.org/2023/1/e41292 UR - http://dx.doi.org/10.2196/41292 UR - http://www.ncbi.nlm.nih.gov/pubmed/36892929 ID - info:doi/10.2196/41292 ER - TY - JOUR AU - Hughes, David Jeffery AU - Chivers, Paola AU - Hoti, Kreshnik PY - 2023/2/13 TI - The Clinical Suitability of an Artificial Intelligence?Enabled Pain Assessment Tool for Use in Infants: Feasibility and Usability Evaluation Study JO - J Med Internet Res SP - e41992 VL - 25 KW - pain assessment KW - clinical utility KW - sensitivity KW - specificity KW - immunization KW - accuracy KW - precision KW - PainChek Infant KW - infant KW - newborn KW - baby KW - babies KW - pain KW - facial KW - artificial intelligence KW - machine learning KW - model KW - detection KW - assessment N2 - Background: Infants are unable to self-report their pain, which, therefore, often goes underrecognized and undertreated. Adequate assessment of pain, including procedural pain, which has short- and long-term consequences, is critical for its management. The introduction of mobile health?based (mHealth) pain assessment tools could address current challenges and is an area requiring further research. Objective: The purpose of this study is to evaluate the accuracy and feasibility aspects of PainChek Infant and, therefore, assess its applicability in the intended setting. Methods: By observing infants just before, during, and after immunization, we evaluated the accuracy and precision at different cutoff scores of PainChek Infant, which is a point-of-care mHealth?based solution that uses artificial intelligence to detect pain and intensity based solely on facial expression. We used receiver operator characteristic analysis to assess interpretability and establish a cutoff score. Clinician comprehensibility was evaluated using a standardized questionnaire. Other feasibility aspects were evaluated based on comparison with currently available observational pain assessment tools for use in infants with procedural pain. Results: Both PainChek Infant Standard and Adaptive modes demonstrated high accuracy (area under the curve 0.964 and 0.966, respectively). At a cutoff score of ?2, accuracy and precision were 0.908 and 0.912 for Standard and 0.912 and 0.897 for Adaptive modes, respectively. Currently available data allowed evaluation of 16 of the 17 feasibility aspects, with only the cost of the outcome measurement instrument unable to be evaluated since it is yet to be determined. PainChek Infant performed well across feasibility aspects, including interpretability (cutoff score defined), ease of administration, completion time (3 seconds), and clinician comprehensibility. Conclusions: This work provides information on the feasibility of using PainChek Infant in clinical practice for procedural pain assessment and monitoring, and demonstrates the accuracy and precision of the tool at the defined cutoff score. UR - https://www.jmir.org/2023/1/e41992 UR - http://dx.doi.org/10.2196/41992 UR - http://www.ncbi.nlm.nih.gov/pubmed/36780223 ID - info:doi/10.2196/41992 ER - TY - JOUR AU - Maarj, Muhammad AU - Pacey, Verity AU - Tofts, Louise AU - Clapham, Matthew AU - Girončs Garcia, Xavier AU - Coda, Andrea PY - 2022/10/26 TI - Validation of an Electronic Visual Analog Scale App for Pain Evaluation in Children and Adolescents With Symptomatic Hypermobility: Cross-sectional Study JO - JMIR Pediatr Parent SP - e41930 VL - 5 IS - 4 KW - hypermobility syndrome KW - Ehlers-Danlos syndrome KW - hypermobility KW - hypermobile KW - mobile application KW - mobile app KW - pain measurement KW - pain KW - validation KW - validate KW - scale KW - measure KW - pain severity KW - pediatric KW - visual analogue scale KW - mHealth KW - mobile health KW - children KW - adolescent KW - youth KW - child KW - digital health tool N2 - Background: Rapid advances in mobile apps for clinical data collection for pain evaluation have resulted in more efficient data handling and analysis than traditional paper-based approaches. As paper-based visual analogue scale (p-VAS) scores are commonly used to assess pain levels, new emerging apps need to be validated prior to clinical application with symptomatic children and adolescents. Objective: This study aimed to assess the validity and reliability of an electronic visual analogue scale (e-VAS) method via a mobile health (mHealth) App in children and adolescents diagnosed with hypermobility spectrum disorder/hypermobile Ehlers-Danlos syndrome (HSD/HEDS) in comparison with the traditional p-VAS. Methods: Children diagnosed with HSD/HEDS aged 5-18 years were recruited from a sports medicine center in Sydney (New South Wales, Australia). Consenting participants assigned in random order to the e-VAS and p-VAS platforms were asked to indicate their current lower limb pain level and completed pain assessment e-VAS or p-VAS at one time point. Instrument agreement between the 2 methods was determined from the intraclass correlation coefficient (ICC) and through Bland?Altman analysis. Results: In total, 43 children with HSD/HEDS aged 11 (SD 3.8) years were recruited and completed this study. The difference between the 2 VAS platforms of median values was 0.20. Bland?Altman analysis revealed a difference of 0.19 (SD 0.95) with limits of agreement ranging ?1.67 to 2.04. An ICC of 0.87 (95% CI 0.78-0.93) indicated good reliability. Conclusions: These findings suggest that the e-VAS mHealth App is a validated tool and a feasible method of collecting pain recording scores when compared with the traditional paper format in children and adolescents with HSD/HEDS. The e-VAS App can be reliably used for pediatric pain evaluation, and it could potentially be introduced into daily clinical practice to improve real-time symptom monitoring. Further research is warranted to investigate the usage of the app for remote support in real clinical settings. UR - https://pediatrics.jmir.org/2022/4/e41930 UR - http://dx.doi.org/10.2196/41930 UR - http://www.ncbi.nlm.nih.gov/pubmed/36287606 ID - info:doi/10.2196/41930 ER - TY - JOUR AU - Lalloo, Chitra AU - Nishat, Fareha AU - Zempsky, William AU - Bakshi, Nitya AU - Badawy, Sherif AU - Ko, Joo Yeon AU - Dampier, Carlton AU - Stinson, Jennifer AU - Palermo, M. Tonya PY - 2022/8/30 TI - Characterizing User Engagement With a Digital Intervention for Pain Self-management Among Youth With Sickle Cell Disease and Their Caregivers: Subanalysis of a Randomized Controlled Trial JO - J Med Internet Res SP - e40096 VL - 24 IS - 8 KW - engagement KW - adolescents KW - caregivers KW - sickle cell KW - pain KW - mHealth KW - self-management KW - digital health analytics KW - mixed methods KW - youth KW - management KW - disease KW - acute pain KW - chronic pain KW - coping KW - North America KW - intervention KW - child KW - digital health KW - program N2 - Background: Sickle cell disease (SCD) is characterized by severe acute pain episodes as well as risk for chronic pain. Digital delivery of SCD pain self-management support may enhance pain self-management skills and accessibility for youth. However, little is known about how youth with SCD and their caregivers engage with digital health programs. iCanCope with pain is a digital pain self-management platform adapted for youth with SCD and caregivers through a user-centered design approach. The program was delivered via a website (separate versions for youth and caregiver) and mobile app (youth only). Objective: We aimed to characterize patterns of user engagement with the iCanCope with SCD program among youth with SCD and their caregivers. Methods: A randomized controlled trial was completed across multiple North American SCD clinics. Eligible youth were aged 12-18 years, diagnosed with SCD, English-speaking, and experiencing moderate-to-severe pain interference. Eligible caregivers were English-speaking with a child enrolled in the study. Dyads were randomized to receive the iCanCope intervention or attention-control education for 8-12 weeks. This report focused on engagement among dyads who received the intervention. User-level analytics were captured. Individual interviews were conducted with 20% of dyads. Descriptive statistics characterized quantitative engagement. Content analysis summarized qualitative interview data. Exploratory analysis tested the hypothesis that caregiver engagement would be positively associated with child engagement. Results: The cohort included primarily female (60% [34/57] of youth; 91% [49/56] of caregivers) and Black (>90% of youth [53/57] and caregivers [50/56]) participants. Among 56 dyads given program access, differential usage patterns were observed: both the youth and caregiver engaged (16/56, 29%), only the youth engaged (24/56, 43%), only the caregiver engaged (1/56, 2%), and neither individual engaged (16/56, 29%). While most youth engaged with the program (40/57, 70%), most caregivers did not (39/56, 70%). Youth were more likely to engage with the app than the website (85% [34/57] versus 68% [23/57]), and the most popular content categories were goal setting, program introduction, and symptom history. Among caregivers, program introduction, behavioral plans, and goal setting were the most popular content areas. As hypothesized, there was a moderate positive association between caregiver and child engagement (?21=6.6; P=.01; ?=0.34). Interviews revealed that most dyads would continue to use the program (11/12, 92%) and recommend it to others (10/12, 83%). The reasons for app versus website preference among youth were ease of use, acceptable time commitment, and interactivity. Barriers to caregiver engagement included high time burden and limited perceived relevance of content. Conclusions: This is one of the first studies to apply digital health analytics to characterize patterns of engagement with SCD self-management among youth and caregivers. The findings will be used to optimize the iCanCope with SCD program prior to release. Trial Registration: ClinicalTrials.gov NCT03201874; https://clinicaltrials.gov/ct2/show/NCT03201874 UR - https://www.jmir.org/2022/8/e40096 UR - http://dx.doi.org/10.2196/40096 UR - http://www.ncbi.nlm.nih.gov/pubmed/36040789 ID - info:doi/10.2196/40096 ER - TY - JOUR AU - Benoit, Britney AU - Cassidy, Christine AU - van Wijlen, Jacqueline AU - Correll, Quinn AU - Campbell-Yeo, Marsha AU - Hendra, Sionnach AU - Martin-Misener, Ruth AU - MacDougall, Jennifer AU - Cameron, Ashley PY - 2022/8/5 TI - Codevelopment of Implementation Interventions to Support Parent-Led Care for Pain in Infants: Protocol for a Qualitative Descriptive Study JO - JMIR Res Protoc SP - e33770 VL - 11 IS - 8 KW - breastfeeding KW - chestfeeding KW - skin-to-skin contact KW - infant pain KW - implementation KW - qualitative N2 - Background: Untreated pain in infants is associated with adverse health outcomes. Despite strong evidence for accessible, effective, and low-cost parent-led pain-relieving interventions such as breastfeeding or chestfeeding and skin-to-skin contact, these interventions are not routinely used. Objective: The objective of this study is to support the implementation of parent-led pain interventions by identifying barriers to and facilitators of parent-led, evidence-informed pain care in infants during acute procedures. In addition, this study aims to develop theory-informed, contextually relevant implementation interventions for supporting the use of parent-led pain care for infants in hospital and community contexts. Methods: This study will consist of 2 phases that follow a systematic, theoretically informed approach guided by the Theoretical Domains Framework and Behavior Change Wheel. In phase 1, we will use a qualitative descriptive design to explore barriers and facilitators to using parent-led pain care in infants from the perspectives of hospital and community-based clinicians, clinical leaders, and families. In phase 2, we will use the Behavior Change Wheel to design tailored implementation interventions that have evidence for effectively addressing identified barriers in collaboration with an advisory committee of administrative, clinical, and family leaders. Results: Ethics approval for this study was obtained in December 2020. As of May 2022, a total of 15 participants have been enrolled in phase 1. The results from all phases will be reported in 2023. Conclusions: Following the completion of this study, we will have co-designed theoretically informed implementation interventions that can be pilot-tested and experimentally applied. The findings will be used to implement parent-led interventions that improve patient safety and health outcomes for diverse families. International Registered Report Identifier (IRRID): DERR1-10.2196/33770 UR - https://www.researchprotocols.org/2022/8/e33770 UR - http://dx.doi.org/10.2196/33770 UR - http://www.ncbi.nlm.nih.gov/pubmed/35930339 ID - info:doi/10.2196/33770 ER - TY - JOUR AU - Cho, Yen-Hua AU - Chiang, Yi-Chien AU - Chu, Tsung-Lan AU - Chang, Chi-Wen AU - Chang, Chun-Chu AU - Tsai, Hsiu-Min PY - 2022/4/29 TI - The Effectiveness of the Buzzy Device for Pain Relief in Children During Intravenous Injection: Quasirandomized Study JO - JMIR Pediatr Parent SP - e15757 VL - 5 IS - 2 KW - hospitalized children KW - intravenous injection KW - pain KW - Buzzy N2 - Background: Intravenous injection is the most common medical treatment and the main cause of pain in hospitalized children. If there is no appropriate health care for pain relief, the proportion of moderate and severe pain often exceeds 70%. With nonpharmaceutical-based pain management, Buzzy is recognized as an effective device for rapidly relieving injection pain in hospitalized children. However, Buzzy is not widely used in Asia and very few experimental studies in Asia have addressed the effectiveness of the Buzzy device at treating needle pain in hospitalized children. Objective: The main purpose of this study was to investigate the effectiveness of the Buzzy device for diminishing pain levels among hospitalized children in Taiwan. Methods: We applied a quasiexperimental design with random assignment. According to the time of admission, child participants were randomly assigned to treatment and nontreatment groups. The Buzzy device was applied as an intervention in this study. The samples size was 30 per group. The study participants were recruited from the pediatric ward of a medical center in northern Taiwan. The research data were collected longitudinally at three time points: before, during, and after intravenous injection. Three instruments were used for assessment: a demographic information sheet, the Wong-Baker Face Scale (WBFS), and the Faces Legs Activity Cry Consolability (FLACC) scale. The data were analyzed by descriptive analysis, the Mann-Whitney U test, the Wilcoxon signed-rank test, and the ?2 test. Results: A total of 60 hospitalized children aged 3 to 7 years participated in this study, including 30 participants in the treatment group and 30 participants in the nontreatment group. The average age of children in the treatment and nontreatment groups was 5.04 years and 4.38 years, respectively. Buzzy significantly mitigated pain in children during intravenous injection with a significant difference between the two groups in pain-related response (FLACC) and actual pain (WBFS) (Z=?3.551, P<.001 and Z=?3.880, P<.001, respectively). The children in the treatment group had a significantly more pleasant experience than those in the nontreatment group (Z=?2.387, P=.02). When Buzzy was employed, the children experienced less pain than they did during previous intravenous injections (Z=?3.643, P<.001). Conclusions: The intervention of using the Buzzy device was effective in reducing pain levels of intravenous injection among hospitalized children. The specific focus on children in Asia makes a valuable contribution to the literature. For clinical application, the reliable pain relief measure of Buzzy can be used in other Asian children to help health care providers improve noninvasive care among children. For future applications, researchers could integrate Buzzy into therapy-related games and a technology-based app to increase the efficiency of use and provide more data collection functions. UR - https://pediatrics.jmir.org/2022/2/e15757 UR - http://dx.doi.org/10.2196/15757 UR - http://www.ncbi.nlm.nih.gov/pubmed/35486419 ID - info:doi/10.2196/15757 ER - TY - JOUR AU - Hoag, A. Jennifer AU - Karst, Jeffrey AU - Bingen, Kristin AU - Palou-Torres, Akasha AU - Yan, Ke PY - 2022/4/18 TI - Distracting Through Procedural Pain and Distress Using Virtual Reality and Guided Imagery in Pediatric, Adolescent, and Young Adult Patients: Randomized Controlled Trial JO - J Med Internet Res SP - e30260 VL - 24 IS - 4 KW - virtual reality KW - procedural KW - pain KW - anxiety KW - pediatric KW - guided imagery N2 - Background: Children with acute and chronic illness undergo frequent, painful, and distressing procedures. Objective: This randomized controlled trial was used to evaluate the effectiveness of guided imagery (GI) versus virtual reality (VR) on the procedural pain and state anxiety of children and young adults undergoing unsedated procedures. We explored the role of trait anxiety and pain catastrophizing in intervention response. Methods: Children and young adults were recruited from the hematology, oncology, and blood and marrow transplant clinics at a children?s hospital. Each study participant completed the GI and VR intervention during separate but consecutive unsedated procedures. Self-report measures of pain and anxiety were completed before and after the procedures. Results: A total of 50 participants (median age 13 years) completed both interventions. GI and VR performed similarly in the management of procedural pain. Those with high pain catastrophizing reported experiencing less nervousness about pain during procedures that used VR than those using GI. State anxiety declined pre- to postprocedure in both interventions; however, the decrease reached the level of significance during the VR intervention only. Those with high trait anxiety had less pain during GI. Conclusions: In our sample, VR worked as well as GI to manage the pain and distress associated with common procedures experienced by children with acute or chronic illnesses. Children who are primed for pain based on beliefs about pain or because of their history of chronic pain had a better response to VR. GI was a better intervention for those with high trait anxiety. Trial Registration: ClinicalTrials.gov NCT04892160; https://clinicaltrials.gov/ct2/show/NCT04892160 UR - https://www.jmir.org/2022/4/e30260 UR - http://dx.doi.org/10.2196/30260 UR - http://www.ncbi.nlm.nih.gov/pubmed/35436209 ID - info:doi/10.2196/30260 ER - TY - JOUR AU - de la Cruz Herrera, Mercedes AU - Fuster-Casanovas, Aďna AU - Miró Catalina, Queralt AU - Cigarrán Mensa, Mireia AU - Alcántara Pinillos, Pablo AU - Vilanova Guitart, Isabel AU - Grau Carrión, Sergi AU - Vidal-Alaball, Josep PY - 2022/4/7 TI - Use of Virtual Reality in the Reduction of Pain After the Administration of Vaccines Among Children in Primary Care Centers: Protocol for a Randomized Clinical Trial JO - JMIR Res Protoc SP - e35910 VL - 11 IS - 4 KW - children KW - virtual reality KW - pain KW - pain perception KW - anxiety KW - vaccination KW - immunization schedule N2 - Background: Pain and anxiety caused by vaccination and other medical procedures in childhood can result in discomfort for both patients and their parents. Virtual reality (VR) is a technology that is capable of entertaining and distracting the user. Among its many applications, we find the improvement of pain management and the reduction of anxiety in patients undergoing medical interventions. Objective: We aim to publish the protocol of a clinical trial for the reduction of pain and anxiety after the administration of 2 vaccines in children aged 3 to 6 years. Methods: We will conduct a randomized, parallel, controlled clinical trial with 2 assigned groups. The intervention group will wear VR goggles during the administration of 2 vaccines, while the control group will receive standard care from a primary care center for the procedure. Randomization will be carried out by using the RandomizedR computer system?a randomization tool of the R Studio program. This trial will be an open or unblinded trial; both the subjects and the investigators will know the assigned treatment groups. Due to the nature of the VR intervention, it will be impossible to blind the patients, caregivers, or observers. However, a blind third-party assessment will be carried out. The study population will include children aged 3 to 6 years who are included in the patient registry and cared for in a primary care center of the region of Central Catalonia. They will receive the following vaccines during the Well-Child checkup: the triple viral+varicella vaccine at 3 years of age and the hepatitis A+diphtheria-tetanus-pertussis vaccine at 6 years of age. Results: The study is scheduled to begin in January 2022 and is scheduled to end in January 2023, which is when the statistical analysis will begin. As of March 2022, a total of 23 children have been recruited, of which 13 have used VR during the vaccination process. In addition, all of the guardians have found that VR helps to reduce pain during vaccination. Conclusions: VR can be a useful tool in pediatric procedures that generate pain and anxiety. International Registered Report Identifier (IRRID): PRR1-10.2196/35910 UR - https://www.researchprotocols.org/2022/4/e35910 UR - http://dx.doi.org/10.2196/35910 UR - http://www.ncbi.nlm.nih.gov/pubmed/35388793 ID - info:doi/10.2196/35910 ER - TY - JOUR AU - Butler, Sonia AU - Sculley, Dean AU - Santos, Derek AU - Fellas, Antoni AU - Girončs, Xavier AU - Singh-Grewal, Davinder AU - Coda, Andrea PY - 2022/2/2 TI - Effectiveness of eHealth and mHealth Interventions Supporting Children and Young People Living With Juvenile Idiopathic Arthritis: Systematic Review and Meta-analysis JO - J Med Internet Res SP - e30457 VL - 24 IS - 2 KW - eHealth KW - mobile health KW - mHealth KW - juvenile idiopathic arthritis KW - pediatric KW - effectiveness KW - pain KW - physical activity KW - health-related quality of life KW - self-management KW - education KW - mobile phone N2 - Background: Juvenile idiopathic arthritis (JIA) management aims to promote remission through timely, individualized, well-coordinated interdisciplinary care using a range of pharmacological, physical, psychological, and educational interventions. However, achieving this goal is workforce-intensive. Harnessing the burgeoning eHealth and mobile health (mHealth) interventions could be a resource-efficient way of supplementing JIA management. Objective: This systematic review aims to identify the eHealth and mHealth interventions that have been proven to be effective in supporting health outcomes for children and young people (aged 1-18 years) living with JIA. Methods: We systematically searched 15 databases (2018-2021). Studies were eligible if they considered children and young people (aged 1-18 years) diagnosed with JIA, an eHealth or mHealth intervention, any comparator, and health outcomes related to the used interventions. Independently, 2 reviewers screened the studies for inclusion and appraised the study quality using the Downs and Black (modified) checklist. Study outcomes were summarized using a narrative, descriptive method and, where possible, combined for a meta-analysis using a random-effects model. Results: Of the 301 studies identified in the search strategy, 15 (5%) fair-to-good?quality studies met the inclusion criteria, which identified 10 interventions for JIA (age 4-18.6 years). Of these 10 interventions, 5 (50%) supported symptom monitoring by capturing real-time data using health applications, electronic diaries, or web-based portals to monitor pain or health-related quality of life (HRQoL). Within individual studies, a preference was demonstrated for real-time pain monitoring over recall pain assessments because of a peak-end effect, improved time efficiency (P=.002), and meeting children?s and young people?s HRQoL needs (P<.001) during pediatric rheumatology consultations. Furthermore, 20% (2/10) of interventions supported physical activity promotion using a web-based program or a wearable activity tracker. The web-based program exhibited a moderate effect, which increased endurance time, physical activity levels, and moderate to vigorous physical activity (standardized mean difference [SMD] 0.60, SD 0.02-1.18; I2=79%; P=.04). The final 30% (3/10) of interventions supported self-management development through web-based programs, or apps, facilitating a small effect, reducing pain intensity (SMD ?0.14, 95% CI ?0.43 to 0.15; I2=53%; P=.33), and increasing disease knowledge and self-efficacy (SMD 0.30, 95% CI 0.03-0.56; I2=74%; P=.03). These results were not statistically significant. No effect was seen regarding pain interference, HRQoL, anxiety, depression, pain coping, disease activity, functional ability, or treatment adherence. Conclusions: Evidence that supports the inclusion of eHealth and mHealth interventions in JIA management is increasing. However, this evidence needs to be considered cautiously because of the small sample size, wide CIs, and moderate to high statistical heterogeneity. More rigorous research is needed on the longitudinal effects of real-time monitoring, web-based pediatric rheumatologist?children and young people interactions, the comparison among different self-management programs, and the use of wearable technologies as an objective measurement for monitoring physical activity before any recommendations that inform current practice can be given. UR - https://www.jmir.org/2022/2/e30457 UR - http://dx.doi.org/10.2196/30457 UR - http://www.ncbi.nlm.nih.gov/pubmed/35107431 ID - info:doi/10.2196/30457 ER - TY - JOUR AU - Lu, Zhaohua AU - Sim, Jin-ah AU - Wang, X. Jade AU - Forrest, B. Christopher AU - Krull, R. Kevin AU - Srivastava, Deokumar AU - Hudson, M. Melissa AU - Robison, L. Leslie AU - Baker, N. Justin AU - Huang, I-Chan PY - 2021/11/3 TI - Natural Language Processing and Machine Learning Methods to Characterize Unstructured Patient-Reported Outcomes: Validation Study JO - J Med Internet Res SP - e26777 VL - 23 IS - 11 KW - natural language processing KW - machine learning KW - PROs KW - pediatric oncology N2 - Background: Assessing patient-reported outcomes (PROs) through interviews or conversations during clinical encounters provides insightful information about survivorship. Objective: This study aims to test the validity of natural language processing (NLP) and machine learning (ML) algorithms in identifying different attributes of pain interference and fatigue symptoms experienced by child and adolescent survivors of cancer versus the judgment by PRO content experts as the gold standard to validate NLP/ML algorithms. Methods: This cross-sectional study focused on child and adolescent survivors of cancer, aged 8 to 17 years, and caregivers, from whom 391 meaning units in the pain interference domain and 423 in the fatigue domain were generated for analyses. Data were collected from the After Completion of Therapy Clinic at St. Jude Children?s Research Hospital. Experienced pain interference and fatigue symptoms were reported through in-depth interviews. After verbatim transcription, analyzable sentences (ie, meaning units) were semantically labeled by 2 content experts for each attribute (physical, cognitive, social, or unclassified). Two NLP/ML methods were used to extract and validate the semantic features: bidirectional encoder representations from transformers (BERT) and Word2vec plus one of the ML methods, the support vector machine or extreme gradient boosting. Receiver operating characteristic and precision-recall curves were used to evaluate the accuracy and validity of the NLP/ML methods. Results: Compared with Word2vec/support vector machine and Word2vec/extreme gradient boosting, BERT demonstrated higher accuracy in both symptom domains, with 0.931 (95% CI 0.905-0.957) and 0.916 (95% CI 0.887-0.941) for problems with cognitive and social attributes on pain interference, respectively, and 0.929 (95% CI 0.903-0.953) and 0.917 (95% CI 0.891-0.943) for problems with cognitive and social attributes on fatigue, respectively. In addition, BERT yielded superior areas under the receiver operating characteristic curve for cognitive attributes on pain interference and fatigue domains (0.923, 95% CI 0.879-0.997; 0.948, 95% CI 0.922-0.979) and superior areas under the precision-recall curve for cognitive attributes on pain interference and fatigue domains (0.818, 95% CI 0.735-0.917; 0.855, 95% CI 0.791-0.930). Conclusions: The BERT method performed better than the other methods. As an alternative to using standard PRO surveys, collecting unstructured PROs via interviews or conversations during clinical encounters and applying NLP/ML methods can facilitate PRO assessment in child and adolescent cancer survivors. UR - https://www.jmir.org/2021/11/e26777 UR - http://dx.doi.org/10.2196/26777 UR - http://www.ncbi.nlm.nih.gov/pubmed/34730546 ID - info:doi/10.2196/26777 ER - TY - JOUR AU - Canares, Therese AU - Parrish, Carisa AU - Santos, Christine AU - Badawi, Alia AU - Stewart, Alyssa AU - Kleinman, Keith AU - Psoter, Kevin AU - McGuire, Joseph PY - 2021/7/28 TI - Pediatric Coping During Venipuncture With Virtual Reality: Pilot Randomized Controlled Trial JO - JMIR Pediatr Parent SP - e26040 VL - 4 IS - 3 KW - pediatrics KW - psychological distress KW - virtual reality KW - procedural pain KW - anxiety KW - phlebotomy N2 - Background: Virtual reality (VR) has shown promise in reducing children?s pain and anxiety during venipuncture, but studies on VR lack objective observations of pediatric coping. Notably, the process of capturing objective behavioral coping data can be labor- and personnel-intensive. Objective: The primary aims of this pilot trial were to assess the feasibility of conducting a trial of VR in a pediatric emergency department and the feasibility of documenting observed coping behaviors during pediatric procedures. Secondarily, this study examined whether VR affects child and caregiver coping and distress during venipuncture in the pediatric emergency department. Methods: This stratified, randomized, controlled pilot trial compared coping and distress between child life?supported VR engagement and child life specialist support without VR during painful procedures in children aged 7-22 years in the pediatric emergency department. An external control (reference group) received no standardized support. Primary feasibility outcomes included rates of recruitment, rates of withdrawal from VR, and rates of completed Child Adult Medical Procedure Interaction Scale-Short Form (CAMPIS-SF) observations. Secondary clinical outcomes were applied to venipuncture procedures and included CAMPIS-SF coping and distress (range 0-1.0), pain and anxiety on a visual analog scale (range 0-10), and cybersickness symptoms. Results: Overall recruitment was 93% (66/71), VR withdrawal rate was 27% (4/15), and of the completed procedures, 100% (63/63) CAMPIS-SF observations were completed. A total of 55 patients undergoing venipuncture in the pediatric emergency department were included in the analyses of clinical outcomes: 15 patients (15 caregivers) randomized to VR, 20 patients (15 caregivers) randomized to child life specialist support, and 20 patients (17 caregivers) in the reference group. Patient coping differed across groups with higher coping in the VR group and child life specialist group than in the reference group (P=.046). There were no significant differences in the distress and pain ratings for patients and caregivers between the groups. Caregivers rated the lowest perceived anxiety in the child life specialist group (P=.03). There was no apparent change in cybersickness symptoms before and after VR use (P=.37). Conclusions: Real-time documentation of observed behaviors in patients and caregivers was feasible during medical procedures in which VR was utilized, particularly with the availability of research staff. VR and child life specialists improved coping in children during venipuncture procedures. Given the high participation rate, future studies to evaluate the efficacy of VR are recommended to determine whether an off-the-shelf VR headset can be a low-cost and low-risk tool to improve children?s coping during venipuncture or other related procedures. Trial Registration: ClinicalTrials.gov NCT03686176; https://clinicaltrials.gov/ct2/show/NCT03686176 UR - https://pediatrics.jmir.org/2021/3/e26040 UR - http://dx.doi.org/10.2196/26040 UR - http://www.ncbi.nlm.nih.gov/pubmed/34319249 ID - info:doi/10.2196/26040 ER - TY - JOUR AU - Logan, E. Deirdre AU - Simons, E. Laura AU - Caruso, J. Thomas AU - Gold, I. Jeffrey AU - Greenleaf, Walter AU - Griffin, Anya AU - King, D. Christopher AU - Menendez, Maria AU - Olbrecht, A. Vanessa AU - Rodriguez, Samuel AU - Silvia, Megan AU - Stinson, N. Jennifer AU - Wang, Ellen AU - Williams, E. Sara AU - Wilson, Luke PY - 2021/4/26 TI - Leveraging Virtual Reality and Augmented Reality to Combat Chronic Pain in Youth: Position Paper From the Interdisciplinary Network on Virtual and Augmented Technologies for Pain Management JO - J Med Internet Res SP - e25916 VL - 23 IS - 4 KW - virtual reality KW - pediatric KW - chronic pain N2 - Background: Virtual reality (VR) and augmented reality (AR) interventions are emerging as promising tools in the treatment of pediatric chronic pain conditions. However, in this young field, there is little consensus to guide the process of engaging in the development and evaluation of targeted VR-based interventions. Objective: The INOVATE-Pain (Interdisciplinary Network on Virtual and Augmented Technologies for Pain management) consortium aims to advance the field of VR for pediatric chronic pain rehabilitation by providing guidance for best practices in the design, evaluation, and dissemination of VR-based interventions targeting this population. Methods: An interdisciplinary meeting of 16 academics, clinicians, industry partners, and philanthropy partners was held in January 2020. Results: Reviewing the state of the field, the consortium identified important directions for research-driven innovation in VR and AR clinical care, highlighted key opportunities and challenges facing the field, and established a consensus on best methodological practices to adopt in future efforts to advance the research and practice of VR and AR in pediatric pain. The consortium also identified important next steps to undertake to continue to advance the work in this promising new area of digital health pain interventions. Conclusions: To realize the promise of this realm of innovation, key ingredients for success include productive partnerships among industry, academic, and clinical stakeholders; a uniform set of outcome domains and measures for standardized evaluation; and widespread access to the latest opportunities, tools, and resources. The INOVATE-Pain collaborative hopes to promote the creation, rigorous yet efficient evaluation, and dissemination of innovative VR-based interventions to reduce pain and improve quality of life for children. UR - https://www.jmir.org/2021/4/e25916 UR - http://dx.doi.org/10.2196/25916 UR - http://www.ncbi.nlm.nih.gov/pubmed/33667177 ID - info:doi/10.2196/25916 ER - TY - JOUR AU - Griffin, Anya AU - Wilson, Luke AU - Feinstein, B. Amanda AU - Bortz, Adeline AU - Heirich, S. Marissa AU - Gilkerson, Rachel AU - Wagner, FM Jenny AU - Menendez, Maria AU - Caruso, J. Thomas AU - Rodriguez, Samuel AU - Naidu, Srinivas AU - Golianu, Brenda AU - Simons, E. Laura PY - 2020/11/23 TI - Virtual Reality in Pain Rehabilitation for Youth With Chronic Pain: Pilot Feasibility Study JO - JMIR Rehabil Assist Technol SP - e22620 VL - 7 IS - 2 KW - digital health care KW - virtual reality KW - immersive technology KW - chronic pain management KW - adolescents N2 - Background: In the field of pain, virtual reality (VR) technology has been increasingly common in the context of procedural pain management. As an interactive technology tool, VR has the potential to be extended beyond acute pain management to chronic pain rehabilitation with a focus on increasing engagement with painful or avoided movements. Objective: We outline the development and initial implementation of a VR program in pain rehabilitation intervention to enhance function in youth with chronic pain. Methods: We present the development, acceptability, feasibility, and utility of an innovative VR program (Fruity Feet) for pediatric pain rehabilitation to facilitate increased upper and lower extremity engagement. The development team was an interdisciplinary group of pediatric experts, including physical therapists, occupational therapists, pain psychologists, anesthesiologists, pain researchers, and a VR software developer. We used a 4-phase iterative development process that engaged clinicians, parents, and patients via interviews and standardized questionnaires. Results: This study included 17 pediatric patients (13 female, 4 male) enrolled in an intensive interdisciplinary pain treatment (IIPT) program, with mean age of 13.24 (range 7-17) years, completing a total of 63 VR sessions. Overall reports of presence were high (mean 28.98; max 40; SD 4.02), suggestive of a high level of immersion. Among those with multisession data (n=8), reports of pain (P<.001), fear (P=.003), avoidance (P=.004), and functional limitations (P=.01) significantly decreased. Qualitative analysis revealed (1) a positive experience with VR (eg, enjoyed VR, would like to utilize the VR program again, felt VR was a helpful tool); (2) feeling distracted from pain while engaged in VR; (3) greater perceived mobility; and (4) fewer clinician-observed pain behaviors during VR. Movement data support the targeted impact of the Fruity Feet compared to other available VR programs. Conclusions: The iterative development process yielded a highly engaging and feasible VR program based on qualitative feedback, questionnaires, and movement data. We discuss next steps for the refinement, implementation, and assessment of impact of VR on chronic pain rehabilitation. VR holds great promise as a tool to facilitate therapeutic gains in chronic pain rehabilitation in a manner that is highly reinforcing and fun. UR - http://rehab.jmir.org/2020/2/e22620/ UR - http://dx.doi.org/10.2196/22620 UR - http://www.ncbi.nlm.nih.gov/pubmed/33226346 ID - info:doi/10.2196/22620 ER - TY - JOUR AU - Smith, Vinayak AU - Warty, Rikain Ritesh AU - Sursas, Arun Joel AU - Payne, Olivia AU - Nair, Amrish AU - Krishnan, Sathya AU - da Silva Costa, Fabricio AU - Wallace, Morrison Euan AU - Vollenhoven, Beverley PY - 2020/11/2 TI - The Effectiveness of Virtual Reality in Managing Acute Pain and Anxiety for Medical Inpatients: Systematic Review JO - J Med Internet Res SP - e17980 VL - 22 IS - 11 KW - virtual reality KW - VR KW - pain management KW - anxiety KW - procedural pain KW - wound management KW - acute pain KW - analgesia KW - pain N2 - Background: Virtual reality is increasingly being utilized by clinicians to facilitate analgesia and anxiolysis within an inpatient setting. There is however, a lack of a clinically relevant review to guide its use for this purpose. Objective: To systematically review the current evidence for the efficacy of virtual reality as an analgesic in the management of acute pain and anxiolysis in an inpatient setting. Methods: A comprehensive search was conducted up to and including January 2019 on PubMed, Ovid Medline, EMBASE, and Cochrane Database of Systematic reviews according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Search terms included virtual reality, vr, and pain. Primary articles with a focus on acute pain in the clinical setting were considered for the review. Primary outcome measures included degree of analgesia afforded by virtual reality therapy, degree of anxiolysis afforded by virtual reality therapy, effect of virtual reality on physiological parameters, side effects precipitated by virtual reality, virtual reality content type, and type of equipment utilized. Results: Eighteen studies were deemed eligible for inclusion in this systematic review; 67% (12/18) of studies demonstrated significant reductions in pain with the utilization of virtual reality; 44% (8/18) of studies assessed the effects of virtual reality on procedural anxiety, with 50% (4/8) of these demonstrating significant reductions; 28% (5/18) of studies screened for side effects with incidence rates of 0.5% to 8%; 39% (7/18) of studies evaluated the effects of virtual reality on autonomic arousal as a biomarker of pain, with 29% (2/7) demonstrating significant changes; 100% (18/18) of studies utilized a head mounted display to deliver virtual reality therapy, with 50% being in active form (participants interacting with the environment) and 50% being in passive form (participants observing the content only). Conclusions: Available evidence suggests that virtual reality therapy can be applied to facilitate analgesia for acute pain in a variety of inpatient settings. Its effects, however, are likely to vary by patient population and indication. This highlights the need for individualized pilot testing of virtual reality therapy?s effects for each specific clinical use case rather than generalizing its use for the broad indication of facilitating analgesia. In addition, virtual reality therapy has the added potential of concurrently providing procedural anxiolysis, thereby improving patient experience and cooperation, while being associated with a low incidence of side effects (nausea, vomiting, eye strain, and dizziness). Furthermore, findings indicated a head mounted display should be utilized to deliver virtual reality therapy in a clinical setting with a slight preference for active over passive virtual reality for analgesia. There, however, appears to be insufficient evidence to substantiate the effect of virtual reality on autonomic arousal, and this should be considered at best to be for investigational uses, at present. UR - https://www.jmir.org/2020/11/e17980 UR - http://dx.doi.org/10.2196/17980 UR - http://www.ncbi.nlm.nih.gov/pubmed/33136055 ID - info:doi/10.2196/17980 ER - TY - JOUR AU - Stinson, N. Jennifer AU - Lalloo, Chitra AU - Hundert, S. Amos AU - Campillo, Sarah AU - Cellucci, Tania AU - Dancey, Paul AU - Duffy, Ciaran AU - Ellsworth, Janet AU - Feldman, M. Brian AU - Huber, M. Adam AU - Johnson, Nicole AU - Jong, Geert't AU - Oen, Kiem AU - Rosenberg, M. Alan AU - Shiff, J. Natalie AU - Spiegel, Lynn AU - Tse, L. Shirley M. AU - Tucker, Lori AU - Victor, Charles Joseph PY - 2020/7/29 TI - Teens Taking Charge: A Randomized Controlled Trial of a Web-Based Self-Management Program With Telephone Support for Adolescents With Juvenile Idiopathic Arthritis JO - J Med Internet Res SP - e16234 VL - 22 IS - 7 KW - eHealth KW - randomized controlled trial KW - adolescents KW - juvenile idiopathic arthritis KW - self-management KW - self-efficacy KW - technology KW - patient education KW - internet KW - pediatric pain N2 - Background: Juvenile idiopathic arthritis (JIA) is a serious and potentially debilitating pediatric illness. Improved disease self-management may help to improve health outcomes. Objective: This study aimed to evaluate the effectiveness of the Teens Taking Charge Web-based self-management intervention in reducing symptoms and improving health-related quality of life (HRQL) in adolescents with JIA compared with a Web-based education control condition. Methods: Adolescents with JIA aged 12 to 18 years were recruited from 11 Canadian pediatric rheumatology centers. Caregivers were invited to participate along with their child. In addition to standard medical care, participants were randomized to receive either (1) the Teens Taking Charge self-management intervention or (2) a Web-based education control condition for a period of 12 weeks. Adolescents in the intervention group completed website modules addressing cognitive behavioral coping skills, stress management, and other self-management topics, while also receiving monthly telephone calls from a trained health coach. Adolescents in the education control group were instructed to view a series of preselected public JIA educational websites and received monthly calls from a coach who asked about their own best efforts at managing JIA. Caregivers in the intervention group completed website modules related to promoting independence and disease self-management in their child. Caregivers in the education control group were instructed to view a series of preselected public JIA educational websites. Outcome assessment occurred at baseline, 12 weeks (posttreatment), and at 6 and 12 months postrandomization. The primary outcomes were pain intensity, pain interference, and HRQL. Secondary outcomes were emotional symptoms, adherence, coping, knowledge, and self-efficacy. Results: In total, 333 adolescents and 306 caregivers were enrolled. Significant overall reductions in pain intensity (P=.02) and pain interference (P=.007) were observed for intervention group participants compared with those in the education control group, after adjusting for baseline levels. There was a significant overall improvement in HRQL related to problems with pain (P=.02) and problems with daily activities (P=.01). There was also a significant difference in the intervention group over time (P=.008) for HRQL related to treatment problems, with the intervention group participants demonstrating improved HRQL by 12 months compared with education control group participants. Both groups showed nonsignificant improvements compared with baseline in other primary outcomes. There were no significant differences between the groups in any secondary outcomes or caregiver-reported outcomes. Conclusions: The results of this randomized trial suggest that the Teens Taking Charge Web-based intervention is effective at reducing both pain intensity and pain interference, as well as improving HRQL in adolescents with JIA, compared with education control. These effects are sustained for up to 12 months following program completion. The Teens Taking Charge program is now publicly available at no cost. Trial Registration: ClinicalTrials.gov NCT01572896; https://clinicaltrials.gov/ct2/show/NCT01572896 UR - https://www.jmir.org/2020/7/e16234 UR - http://dx.doi.org/10.2196/16234 UR - http://www.ncbi.nlm.nih.gov/pubmed/32723728 ID - info:doi/10.2196/16234 ER - TY - JOUR AU - Ahmadpour, Naseem AU - Weatherall, David Andrew AU - Menezes, Minal AU - Yoo, Soojeong AU - Hong, Hanyang AU - Wong, Gail PY - 2020/7/17 TI - Synthesizing Multiple Stakeholder Perspectives on Using Virtual Reality to Improve the Periprocedural Experience in Children and Adolescents: Survey Study JO - J Med Internet Res SP - e19752 VL - 22 IS - 7 KW - virtual reality KW - periprocedural anxiety KW - children KW - adolescents KW - stakeholder perspective KW - design KW - VR KW - pediatrics KW - patient experience KW - app KW - eHealth N2 - Background: Virtual reality (VR) technology is a powerful tool for augmenting patient experience in pediatric settings. Incorporating the needs and values of stakeholders in the design of VR apps in health care can contribute to better outcomes and meaningful experiences for patients. Objective: We used a multiperspective approach to investigate how VR apps can be designed to improve the periprocedural experiences of children and adolescents, particularly those with severe anxiety. Methods: This study included a focus group (n=4) and a survey (n=56) of clinicians. Semistructured interviews were conducted with children and adolescents in an immunization clinic (n=3) and perioperative setting (n=65) and with parents and carers in an immunization clinic (n=3) and perioperative setting (n=35). Results: Qualitative data were examined to determine the experience and psychological needs and intervention and design strategies that may contribute to better experiences for children in three age groups (4-7, 8-11, and 12-17 years). Quantitative data were used to identify areas of priority for future VR interventions. Conclusions: We propose a set of ten design considerations for the creation of future VR experiences for pediatric patients. Enhancing patient experience may be achieved by combining multiple VR solutions through a holistic approach considering the roles of clinicians and carers and the temporality of the patient?s experience. These situations require personalized solutions to fulfill the needs of pediatric patients before and during the medical procedure. In particular, communication should be placed at the center of preprocedure solutions, while emotional goals can be embedded into a procedure-focused VR app to help patients shift their focus in a meaningful way to build skills to manage their anxiety. UR - http://www.jmir.org/2020/7/e19752/ UR - http://dx.doi.org/10.2196/19752 UR - http://www.ncbi.nlm.nih.gov/pubmed/32706671 ID - info:doi/10.2196/19752 ER - TY - JOUR AU - Toupin April, Karine AU - Stinson, Jennifer AU - Cavallo, Sabrina AU - Proulx, Laurie AU - Wells, A. George AU - Duffy, M. Ciarán AU - ElHindi, Tania AU - Longmuir, E. Patricia AU - Brosseau, Lucie PY - 2020/7/6 TI - Yoga and Aerobic Dance for Pain Management in Juvenile Idiopathic Arthritis: Protocol for a Pilot Randomized Controlled Trial JO - JMIR Res Protoc SP - e12823 VL - 9 IS - 7 KW - juvenile idiopathic arthritis KW - yoga KW - aerobic exercise KW - dance KW - pain management KW - pilot N2 - Background: Juvenile idiopathic arthritis (JIA) is one of the most common types of arthritis among children. According to JIA guidelines for physical activity (PA), structured PA interventions led to improved health outcomes. However, many PA programs, such as yoga and aerobic dance, have not been studied in this population despite being popular among youth. Web-based PA programs could provide patients with accessible and affordable interventions. Objective: The primary aims of the proposed pilot randomized controlled trial (RCT) are to examine (1) the feasibility of conducting a full-scale RCT to evaluate the effectiveness of two popular types of PA: a yoga training program and an aerobic dance training program, in female adolescents (aged 13-18 years) with JIA compared with an electronic pamphlet control group; and (2) the acceptability of these interventions. Methods: A three-arm prospective randomized open-label study with a parallel group design will be used. A total of 25 female adolescents with JIA who have pain will be randomized in a ratio of 2:2:1 to one of the 3 groups: (1) online yoga training program (group A: n=10); (2) online aerobic dance training program (group B: n=10); and (3) electronic pamphlet control group (group C: n=5). Participants in groups A and B will complete 3 individual 1-hour sessions per week using online exercise videos, as well as a 1-hour virtual group session per week using a videoconferencing platform for 12 weeks. Participants from all groups will have access to an electronic educational pamphlet on PA for arthritis developed by the Arthritis Society. All participants will also take part in weekly online consultations with a research coordinator and discussions on Facebook with participants from their own group. Feasibility (ie, recruitment rate, self-reported adherence to the interventions, dropout rates, and percentage of missing data), acceptability, and usability of Facebook and the videoconferencing platform will be assessed at the end of the program. Pain intensity, participation in general PA, morning stiffness, functional status, fatigue, self-efficacy, patient global assessment, disease activity, and adverse events will be assessed using self-administered electronic surveys at baseline and then weekly until the end of the 12-week program. Results: This pilot RCT has been funded by the Arthritis Health Professions Association. This protocol was approved by the Children?s Hospital of Eastern Ontario Research Ethics Board (#17/08X). As of May 11, 2020, recruitment and data collection have not started. Conclusions: To our knowledge, this is the first study to evaluate the effectiveness of yoga and aerobic dance as pain management interventions for female adolescents with JIA. The use of online programs to disseminate these 2 PA interventions may facilitate access to alternative methods of pain management. This study can lead to a full-scale RCT. International Registered Report Identifier (IRRID): PRR1-10.2196/12823 UR - https://www.researchprotocols.org/2020/7/e12823 UR - http://dx.doi.org/10.2196/12823 UR - http://www.ncbi.nlm.nih.gov/pubmed/32442139 ID - info:doi/10.2196/12823 ER - TY - JOUR AU - Slater, Helen AU - Stinson, N. Jennifer AU - Jordan, E. Joanne AU - Chua, Jason AU - Low, Ben AU - Lalloo, Chitra AU - Pham, Quynh AU - Cafazzo, A. Joseph AU - Briggs, M. Andrew PY - 2020/6/5 TI - Evaluation of Digital Technologies Tailored to Support Young People?s Self-Management of Musculoskeletal Pain: Mixed Methods Study JO - J Med Internet Res SP - e18315 VL - 22 IS - 6 KW - musculoskeletal pain KW - mHealth KW - eHealth KW - self-management KW - adolescent KW - mobile phone KW - smartphone N2 - Background: Digital technologies connect young people with health services and resources that support their self-care. The lack of accessible, reliable digital resources tailored to young people with persistent musculoskeletal pain is a significant gap in the health services in Australia. Recognizing the intense resourcing required to develop and implement effective electronic health (eHealth) interventions, the adaptation of extant, proven digital technologies may improve access to pain care with cost and time efficiencies. Objective: This study aimed to test the acceptability and need for adaptation of extant digital technologies, the painHEALTH website and the iCanCope with Pain app, for use by young Australians with musculoskeletal pain. Methods: A 3-phased, mixed methods evaluation was undertaken from May 2019 to August 2019 in Australia. Young people aged 15 to 25 years with musculoskeletal pain for >3 months were recruited. Phases were sequential: (1) phase 1, participant testing (3 groups, each of n=5) of co-designed website prototypes compared with a control website (painHEALTH), with user tasks mapped to eHealth quality and engagement criteria; (2) phase 2, participants? week-long use of the iCanCope with Pain app with engagement data captured using a real-time analytic platform (daily check-ins for pain, interference, sleep, mood, physical activity, and energy levels; goal setting; and accessing resources); and (3) phase 3, semistructured interviews were conducted to gain insights into participants? experiences of using these digital technologies. Results: Fifteen young people (12/15, 80% female; mean age 20.5 [SD 3.3] years; range 15-25 years) participated in all 3 phases. The phase 1 aggregated group data informed the recommendations used to guide 3 rapid cycles of prototype iteration. Adaptations included optimizing navigation, improving usability (functionality), and enhancing content to promote user engagement and acceptability. In phase 2, all participants checked in, with the highest frequency of full check-ins attributed to pain intensity (183/183, 100.0%), pain interference (175/183, 95.6%), and mood (152/183, 83.1%), respectively. Individual variability was evident for monitoring progress with the highest frequency of history views for pain intensity (51/183, 32.3%), followed by pain interference (24/183, 15.2%). For the goals set feature, 87% (13/15) of participants set a total of 42 goals covering 5 areas, most frequently for activity (35/42, 83%). For phase 3, metasynthesis of qualitative data highlighted that these digital tools were perceived as youth-focused and acceptable. A total of 4 metathemes emerged: (1) importance of user-centered design to leverage user engagement; (2) website design (features) promoting user acceptability and engagement; (3) app functionality supporting self-management; and (4) the role of wider promotion, health professional digital prescriptions, and strategies to ensure longer-term engagement. Conclusions: Leveraging extant digital tools, with appropriate user-informed adaptations, can help to build capacity tailored to support young people?s self-management of musculoskeletal pain. UR - https://www.jmir.org/2020/6/e18315 UR - http://dx.doi.org/10.2196/18315 UR - http://www.ncbi.nlm.nih.gov/pubmed/32442143 ID - info:doi/10.2196/18315 ER - TY - JOUR AU - Alonso Puig, Mario AU - Alonso-Prieto, Mercedes AU - Miró, Jordi AU - Torres-Luna, Raquel AU - Plaza López de Sabando, Diego AU - Reinoso-Barbero, Francisco PY - 2020/3/30 TI - The Association Between Pain Relief Using Video Games and an Increase in Vagal Tone in Children With Cancer: Analytic Observational Study With a Quasi-Experimental Pre/Posttest Methodology JO - J Med Internet Res SP - e16013 VL - 22 IS - 3 KW - hematology oncology KW - pediatric patient KW - acute pain KW - patient-controlled analgesia KW - video pupilometer KW - analgesia nociception index N2 - Background: Patients with secondary pain due to mucositis after chemotherapy require treatment with morphine. Use of electronic video games (EVGs) has been shown to be an effective method of analgesia in other clinical settings. Objective: The main objective of this study was to assess the association between the use of EVGs and the intensity of pain caused by chemotherapy-induced mucositis in pediatric patients with cancer. The secondary objective was to assess the association between changes in pain intensity and sympathetic-parasympathetic balance in this sample of pediatric patients. Methods: Clinical records were compared between the day prior to the use of EVGs and the day after the use of EVGs. The variables were variations in pupil size measured using the AlgiScan video pupilometer (IDMed, Marseille, France), heart rate variability measured using the Analgesia Nociception Index (ANI) monitor (Mdoloris Medical Systems, Loos, France), intensity of pain measured using the Numerical Rating Scale (score 0-10), and self-administered morphine pump parameters. Results: Twenty patients (11 girls and nine boys; mean age 11.5 years, SD 4.5 years; mean weight 41.5 kg, SD 20.7 kg) who met all the inclusion criteria were recruited. EVGs were played for a mean of 2.3 (SD 1.3) hours per day, resulting in statistically significant changes. After playing EVGs, there was significantly lower daily morphine use (before vs after playing EVGs: 35.9 vs 28.6 µg/kg/day, P=.003), lower demand for additional pain relief medication (17 vs 9.6 boluses in 24 hours, P=.001), lower scores of incidental pain intensity (7.7 vs 5.4, P=.001), lower scores of resting pain (4.8 vs 3.2, P=.01), and higher basal parasympathetic tone as measured using the ANI monitor (61.8 vs 71.9, P=.009). No variation in pupil size was observed with the use of EVGs. Conclusions: The use of EVGs in pediatric patients with chemotherapy-induced mucositis has a considerable analgesic effect, which is associated physiologically with an increase in parasympathetic vagal tone despite lower consumption of morphine. UR - http://www.jmir.org/2020/3/e16013/ UR - http://dx.doi.org/10.2196/16013 UR - http://www.ncbi.nlm.nih.gov/pubmed/32224482 ID - info:doi/10.2196/16013 ER - TY - JOUR AU - Chambers, T. Christine AU - Dol, Justine AU - Parker, A. Jennifer AU - Caes, Line AU - Birnie, A. Kathryn AU - Taddio, Anna AU - Campbell-Yeo, Marsha AU - Halperin, A. Scott AU - Langille, Jennifer PY - 2020/3/4 TI - Implementation Effectiveness of a Parent-Directed YouTube Video (?It Doesn?t Have To Hurt?) on Evidence-Based Strategies to Manage Needle Pain: Descriptive Survey Study JO - JMIR Pediatr Parent SP - e13552 VL - 3 IS - 1 KW - pain management KW - child KW - knowledge translation KW - social media N2 - Background: Despite the availability of high-quality evidence and clinical practice guidelines for the effective management of pediatric pain, this evidence is rarely used in practice for managing children?s pain from needle procedures such as vaccinations. Parents are generally unaware of pain management strategies they can use with their children. Objective: This study aimed to develop, implement, and evaluate the implementation effectiveness of a parent-directed YouTube video on evidence-based strategies to manage needle pain in children. Methods: This was a descriptive study. Analytics were extracted from YouTube to describe video reach. A Web-based survey was used to seek parent and health care professional (HCP) feedback about the video. The 2-minute 18-second video was launched on YouTube on November 4, 2013. In the video, a 4-year-old girl tells parents what they should and should not do to help needles hurt less. The key evidence-based messages shared in the video were distraction, deep breathing, and topical anesthetic creams. A group of parents (n=163) and HCPs (n=278) completed the Web-based survey. Measures of reach included number of unique views, country where the video was viewed, sex of the viewer, and length of watch time. The Web-based survey assessed implementation outcomes of the video, such as acceptability, appropriateness, penetration, and adoption. Results: As of November 4, 2018 (5 years after launch), the video had 237,132 unique views from 182 countries, with most viewers watching an average of 55.1% (76/138 seconds) of the video. Overall, both parents and HCPs reported strong acceptance of the video (ie, they liked the video, found it helpful, and felt more confident) and reported significant improvements in plans to use distraction, deep breathing, and topical anesthetic creams. Conclusions: This parent-directed YouTube video was an acceptable and appropriate way to disseminate evidence about the procedure of pain management to a large number of parents. UR - http://pediatrics.jmir.org/2020/1/e13552/ UR - http://dx.doi.org/10.2196/13552 UR - http://www.ncbi.nlm.nih.gov/pubmed/32130190 ID - info:doi/10.2196/13552 ER - TY - JOUR AU - Ahmadpour, Naseem AU - Keep, Melanie AU - Janssen, Anna AU - Rouf, Saiyara Anika AU - Marthick, Michael PY - 2020/1/31 TI - Design Strategies for Virtual Reality Interventions for Managing Pain and Anxiety in Children and Adolescents: Scoping Review JO - JMIR Serious Games SP - e14565 VL - 8 IS - 1 KW - virtual reality KW - distraction KW - pain KW - anxiety KW - children KW - adolescents KW - design N2 - Background: Virtual reality (VR) technology has been explored in the health sector as a novel tool for supporting treatment side effects, including managing pain and anxiety. VR has recently become more available with the launch of low-cost devices and apps. Objective: This study aimed to provide an updated review of the research into VR use for pain and anxiety in pediatric patients undergoing medical procedures. Specifically, we wanted to gain an understanding of the techniques and goals used in selecting or designing VR apps in this context. Methods: We performed a scoping review. To identify relevant studies, we searched three electronic databases. Two authors screened the titles and abstracts for relevance and eligibility criteria. Results: Overall, 1386 articles published between 2013 and 2018 were identified. In total 18 articles were included in the review, with 7 reporting significant reduction in pediatric pain or anxiety, 3 testing but finding no significant impact of the VR apps employed, and the rest not conducting any test of significance. We identified 9 articles that were based on VR apps specifically designed and tailored for pediatric patients. The findings were analyzed to develop a holistic model and describe the product, experience, and intervention aspects that need to be considered in designing such medical VR apps. Conclusions: VR has been demonstrated to be a viable choice for managing pain and anxiety in a range of medical treatments. However, commercial products lack diversity and meaningful design strategies are limited beyond distraction techniques. We propose future VR interventions to explore skill-building goals in apps characterized by dynamic feedback to the patient and experiential and product qualities that enable them to be an active participant in managing their own care. To achieve this, design must be part of the development. UR - http://games.jmir.org/2020/1/e14565/ UR - http://dx.doi.org/10.2196/14565 UR - http://www.ncbi.nlm.nih.gov/pubmed/32012042 ID - info:doi/10.2196/14565 ER - TY - JOUR AU - Lee, Rachael Rebecca AU - Shoop-Worrall, Stephanie AU - Rashid, Amir AU - Thomson, Wendy AU - Cordingley, Lis PY - 2020/1/30 TI - ?Asking Too Much??: Randomized N-of-1 Trial Exploring Patient Preferences and Measurement Reactivity to Frequent Use of Remote Multidimensional Pain Assessments in Children and Young People With Juvenile Idiopathic Arthritis JO - J Med Internet Res SP - e14503 VL - 22 IS - 1 KW - mHealth KW - pain KW - pain assessment KW - juvenile idiopathic arthritis KW - patient reported outcomes KW - pediatrics N2 - Background: Remote monitoring of pain using multidimensional mobile health (mHealth) assessment tools is increasingly being adopted in research and care. This assessment method is valuable because it is challenging to capture pain histories, particularly in children and young people in diseases where pain patterns can be complex, such as juvenile idiopathic arthritis (JIA). With the growth of mHealth measures and more frequent assessment, it is important to explore patient preferences for the timing and frequency of administration of such tools and consider whether certain administrative patterns can directly impact on children?s pain experiences. Objective: This study aimed to explore the feasibility and influence (in terms of objective and subjective measurement reactivity) of several time sampling strategies in remote multidimensional pain reporting. Methods: An N-of-1 trial was conducted in a subset of children and young people with JIA and their parents recruited to a UK cohort study. Children were allocated to 1 of 4 groups. Each group followed a different schedule of completion of MPT for 8 consecutive weeks. Each schedule included 2 blocks, each comprising 4 different randomized time sampling strategies, with each strategy occurring once within each 4-week block. Children completed MPT according to time sampling strategies: once-a-day, twice-a-day, once-a-week, and as-and-when pain was experienced. Adherence to each strategy was calculated. Participants completed the Patient-Reported Outcomes Measurement Information System Pain Interference Scale at the end of each week to explore objective reactivity. Differences in pain interference scores between time sampling strategies were assessed graphically and using Friedman tests. Children and young people and their parents took part in a semistructured interview about their preferences for different time sampling strategies and to explore subjective reactivity. Results: A total of 14 children and young people (aged 7-16 years) and their parents participated. Adherence to pain reporting was higher in less intense time sampling strategies (once-a-week=63% [15/24]) compared with more intense time sampling strategies (twice-a-day=37.8% [127/336]). There were no statistically significant differences in pain interference scores between sampling strategies. Qualitative findings from interviews suggested that children preferred once-a-day (6/14, 43%) and as-and-when pain reporting (6/14, 43%). Creating routine was one of the most important factors for successful reporting, while still ensuring that comprehensive information about recent pain was captured. Conclusions: Once-a-day pain reporting provides rich contextual information. Although patients were less adherent to this preferred sampling strategy, once-a-day reporting still provides more frequent assessment opportunities compared with other less intense or overburdensome schedules. Important issues for the design of studies and care incorporating momentary assessment techniques were identified. We demonstrate that patient reporting preferences are key to accommodate and are important where data capture quality is key. Our findings support frequent administration of such tools, using daily reporting methods where possible. UR - http://www.jmir.org/2020/1/e14503/ UR - http://dx.doi.org/10.2196/14503 UR - http://www.ncbi.nlm.nih.gov/pubmed/32012051 ID - info:doi/10.2196/14503 ER - TY - JOUR AU - Shaballout, Nour AU - Neubert, Till-Ansgar AU - Boudreau, Shellie AU - Beissner, Florian PY - 2019/09/05 TI - From Paper to Digital Applications of the Pain Drawing: Systematic Review of Methodological Milestones JO - JMIR Mhealth Uhealth SP - e14569 VL - 7 IS - 9 KW - pain drawing KW - digital pain drawing KW - pain chart KW - pain map KW - pain body map KW - pain diagram KW - ehealth KW - medical app N2 - Background: In a pain drawing (PD), the patient shades or marks painful areas on an illustration of the human body. This simple yet powerful tool captures essential aspects of the subjective pain experience, such as localization, intensity, and distribution of pain, and enables the extraction of meaningful information, such as pain area, widespreadness, and segmental pattern. Starting as a simple pen-on-paper tool, PDs are now sophisticated digital health applications paving the way for many new and exciting basic translational and clinical applications. Objective: Grasping the full potential of digital PDs and laying the groundwork for future medical PD apps requires an understanding of the methodological developments that have shaped our current understanding of uses and design. This review presents methodological milestones in the development of both pen-on-paper and digital PDs, thereby offering insight into future possibilities created by the transition from paper to digital. Methods: We conducted a systematic literature search covering PD acquisition, conception of PDs, PD analysis, and PD visualization. Results: The literature search yielded 435 potentially relevant papers, from which 53 methodological milestones were identified. These milestones include, for example, the grid method to quantify pain area, the pain-frequency maps, and the use of artificial neural networks to facilitate diagnosis. Conclusions: Digital technologies have had a significant influence on the evolution of PDs, whereas their versatility is leading to ever new applications in the field of medical apps and beyond. In this process, however, there is a clear need for better standardization and a re-evaluation of methodological and technical limitations that no longer apply today. UR - https://mhealth.jmir.org/2019/9/e14569/ UR - http://dx.doi.org/10.2196/14569 UR - http://www.ncbi.nlm.nih.gov/pubmed/31489841 ID - info:doi/10.2196/14569 ER - TY - JOUR AU - Dunsmuir, Dustin AU - Wu, Helen AU - Sun, Terri AU - West, C. Nicholas AU - Lauder, R. Gillian AU - Görges, Matthias AU - Ansermino, Mark J. PY - 2019/07/04 TI - A Postoperative Pain Management Mobile App (Panda) for Children at Home After Discharge: Usability and Feasibility JO - JMIR Perioper Med SP - e12305 VL - 2 IS - 2 KW - pain management KW - pain, postoperative period KW - outpatients KW - mobile apps KW - child KW - parents N2 - Background: Emphasis on outpatient pediatric surgical procedures places the burden of responsibility for postoperative pain management on parents or guardians. Panda is a mobile phone app that provides scheduled medication alerts and allows parents to track their child?s pain and medication administration. We have previously tested and optimized the usability and feasibility of Panda within the hospital setting. Objective: The purpose of this study was to evaluate and optimize the usability and feasibility of Panda for use at home based on alert response adherence (response to any medication notification within 1 hour) and parents? satisfaction. Methods: Parents or guardians of children aged 3 to 18 years undergoing day surgery were recruited to use Panda at home for 1 to 7 days to manage their scheduled medications and to assess their child?s pain. After the surgical procedure, a research assistant guided parents through app setup before independent use at home. We aimed to recruit 10 child-caregiver pairs in each of three rounds of evaluation. Each user?s adherence with the recommended medication alerts was analyzed through audit-trail data generated during the use of the app. We used the Computer System Usability Questionnaire and a poststudy phone interview to evaluate the app?s ease of use and identify major barriers to adoption. Suggestions provided during the interviews were used to improve the app between each round. Results: Twenty-nine child-caregiver pairs participated in three rounds, using the app for 1 to 5 days. Alert response adherence (response to any medication notification within 1 hour) improved as the study progressed: participants responded to a median 30% (interquartile range [IQR] 22%-33%) of alerts within 1 hour in round 1, and subsequently to median 60% (IQR 44%-64%) in round 2 and median 64% (IQR 56%-72%) in round 3 (P=.005). Similarly, response times decreased from median 131 (IQR 77-158) minutes in round 1 to median 31 (IQR 18-61) minutes in round 2 and median 10 (IQR 2-14) minutes in round 3 (P=.002). Analysis of interview feedback from the first two rounds revealed usability issues, such as complaints of too many pages and trouble hearing app alerts, which were addressed to streamline app function, as well as improve visual appearance and audible alerts. Conclusions: It is feasible for parents or guardians to use Panda at home to manage their child?s medication schedule and track their pain. Simple modifications to the app?s alert sounds and user interface improved response times. UR - https://periop.jmir.org/2019/2/e12305/ UR - http://dx.doi.org/10.2196/12305 UR - http://www.ncbi.nlm.nih.gov/pubmed/33393928 ID - info:doi/10.2196/12305 ER - TY - JOUR AU - Lee, Rachael Rebecca AU - Rashid, Amir AU - Ghio, Daniela AU - Thomson, Wendy AU - Cordingley, Lis PY - 2019/07/02 TI - ?Seeing Pain Differently?: A Qualitative Investigation Into the Differences and Similarities of Pain and Rheumatology Specialists? Interpretation of Multidimensional Mobile Health Pain Data From Children and Young People With Juvenile Idiopathic Arthritis JO - JMIR Mhealth Uhealth SP - e12952 VL - 7 IS - 7 KW - mHeath KW - pain assessment KW - juvenile idiopathic arthritis KW - focus group KW - qualitative research N2 - Background: In contrast to the use of traditional unidimensional paper-based scales, a mobile health (mHealth) assessment of pain in children and young people (CYP) with juvenile idiopathic arthritis (JIA) enables comprehensive and complex multidimensional pain data to be captured remotely by individuals. However, how professionals use multidimensional pain data to interpret and synthesize pain reports gathered using mHealth tools is not yet known. Objective: The aim of this study was to explore the salience and prioritization of different mHealth pain features as interpreted by key stakeholders involved in research and management of pain in CYP with JIA. Methods: Pain and rheumatology specialists were purposively recruited via professional organizations. Face-to-face focus groups were conducted for each specialist group. Participants were asked to rank order 9 static vignette scenarios created from real patient mHealth multidimensional pain data. These data had been collected by a researcher in a separate study using My Pain Tracker, a valid and acceptable mHealth iPad pain communication tool that collects information about intensity, severity, location, emotion, and pictorial pain qualities. In the focus groups, specialists discussed their decision-making processes behind each rank order in the focus groups. The total group rank ordering of vignette scenarios was calculated. Qualitative data from discussions were analyzed using latent thematic analysis. Results: A total of 9 pain specialists took part in 1 focus group and 10 rheumatology specialists in another. In pain specialists, the consensus for the highest pain experience (44%) was poorer than their ranking of the lowest pain experiences (55%). Conversely, in rheumatology specialists, the consensus for the highest pain experience (70%) was stronger than their ranking of the lowest pain experience (50%). Pain intensity was a high priority for pain specialists, but rheumatology specialists gave high priority to intensity and severity taken together. Pain spread was highly prioritized, with the number of pain locations (particular areas or joints) being a high priority for both groups; radiating pain was a high priority for pain specialists only. Pain emotion was challenging for both groups and was only perceived to be a high priority when specialists had additional confirmatory evidence (such as information about pain interference or clinical observations) to validate the pain emotion report. Pain qualities such as particular word descriptors, use of the color red, and fire symbols were seen to be high priority by both groups in interpretation of CYP pain reports. Conclusions: Pain interpretation is complex. Findings from this study of specialists? decision-making processes indicate which aspects of pain are prioritized and weighted more heavily than others by those interpreting mHealth data. Findings are useful for developing electronic graphical summaries which assist specialists in interpreting patient-reported mHealth pain data more efficiently in clinical and research settings. UR - https://mhealth.jmir.org/2019/7/e12952/ UR - http://dx.doi.org/10.2196/12952 UR - http://www.ncbi.nlm.nih.gov/pubmed/31267979 ID - info:doi/10.2196/12952 ER - TY - JOUR AU - Hu, Xiao-Su AU - Nascimento, D. Thiago AU - Bender, C. Mary AU - Hall, Theodore AU - Petty, Sean AU - O?Malley, Stephanie AU - Ellwood, P. Roger AU - Kaciroti, Niko AU - Maslowski, Eric AU - DaSilva, F. Alexandre PY - 2019/06/28 TI - Feasibility of a Real-Time Clinical Augmented Reality and Artificial Intelligence Framework for Pain Detection and Localization From the Brain JO - J Med Internet Res SP - e13594 VL - 21 IS - 6 KW - pain KW - spectroscopy, near-infrared KW - virtual reality KW - artificial intelligence N2 - Background: For many years, clinicians have been seeking for objective pain assessment solutions via neuroimaging techniques, focusing on the brain to detect human pain. Unfortunately, most of those techniques are not applicable in the clinical environment or lack accuracy. Objective: This study aimed to test the feasibility of a mobile neuroimaging-based clinical augmented reality (AR) and artificial intelligence (AI) framework, CLARAi, for objective pain detection and also localization direct from the patient?s brain in real time. Methods: Clinical dental pain was triggered in 21 patients by hypersensitive tooth stimulation with 20 consecutive descending cold stimulations (32°C-0°C). We used a portable optical neuroimaging technology, functional near-infrared spectroscopy, to gauge their cortical activity during evoked acute clinical pain. The data were decoded using a neural network (NN)?based AI algorithm to classify hemodynamic response data into pain and no-pain brain states in real time. We tested the performance of several networks (NN with 7 layers, 6 layers, 5 layers, 3 layers, recurrent NN, and long short-term memory network) upon reorganized data features on pain diction and localization in a simulated real-time environment. In addition, we also tested the feasibility of transmitting the neuroimaging data to an AR device, HoloLens, in the same simulated environment, allowing visualization of the ongoing cortical activity on a 3-dimensional brain template virtually plotted on the patients? head during clinical consult. Results: The artificial neutral network (3-layer NN) achieved an optimal classification accuracy at 80.37% (126,000/156,680) for pain and no pain discrimination, with positive likelihood ratio (PLR) at 2.35. We further explored a 3-class localization task of left/right side pain and no-pain states, and convolutional NN-6 (6-layer NN) achieved highest classification accuracy at 74.23% (1040/1401) with PLR at 2.02. Conclusions: Additional studies are needed to optimize and validate our prototype CLARAi framework for other pains and neurologic disorders. However, we presented an innovative and feasible neuroimaging-based AR/AI concept that can potentially transform the human brain into an objective target to visualize and precisely measure and localize pain in real time where it is most needed: in the doctor?s office. International Registered Report Identifier (IRRID): RR1-10.2196/13594 UR - https://www.jmir.org/2019/6/e13594/ UR - http://dx.doi.org/10.2196/13594 UR - http://www.ncbi.nlm.nih.gov/pubmed/31254336 ID - info:doi/10.2196/13594 ER - TY - JOUR AU - Verschueren, Sarah AU - van Aalst, June AU - Bangels, Anne-Marie AU - Toelen, Jaan AU - Allegaert, Karel AU - Buffel, Connor AU - Vander Stichele, Geert PY - 2019/6/1 TI - Development of CliniPup, a Serious Game Aimed at Reducing Perioperative Anxiety and Pain in Children: Mixed Methods Study JO - JMIR Serious Games SP - e12429 VL - 7 IS - 2 KW - serious games for health KW - behavior change KW - perioperative pain KW - perioperative anxiety KW - pediatric KW - ambulatory surgery N2 - Background: An increasing number of children undergo ambulatory surgery each year, and a significant proportion experience substantial preoperative anxiety and postoperative pain. The management of perioperative anxiety and pain remains challenging in children and is inadequate, which negatively impacts the physical, psychosocial, and economic outcomes. Existing nonpharmacological interventions are costly, time consuming, vary in availability, and lack benefits. Therefore, there is a need for an evidence-based, accessible, nonpharmacological intervention as an adjunct to existing pharmacological alternatives to reduce perioperative anxiety and pain in children undergoing ambulatory surgery. Technology-enabled interventions have been proposed as a method to address the unmet need in this setting. In particular, serious games hold a unique potential to change health beliefs and behaviors in children. Objective: The objective of this research was to describe the rationale, scientific evidence, design aspects, and features of CliniPup, a serious game aimed at reducing perioperative anxiety and pain in children undergoing ambulatory surgery. Methods: The SERES Framework for serious game development was used to create the serious game, CliniPup. In particular, we used a mixed methods approach that consisted of a structured literature review supplemented with ethnographic research, such as expert interviews and a time-motion exercise. The resulting scientific evidence base was leveraged to ensure that the resulting serious game was relevant, realistic, and theory driven. A participatory design approach was applied, wherein clinical experts qualitatively reviewed several versions of the serious game, and an iterative creative process was used to integrate the applicable feedback. Results: CliniPup, a serious game, was developed to incorporate a scientific evidence base from a structured literature review, realistic content collected during ethnographic research such as expert interviews, explicit pedagogical objectives from scientific literature, and game mechanics and user interface design that address key aspects of the evidence. Conclusions: This report details the systematic development of CliniPup, a serious game aimed at reducing perioperative anxiety and pain in children undergoing ambulatory surgery. Clinical experts validated CliniPup?s underlying scientific evidence base and design foundations, suggesting that it was well designed for preliminary evaluation in the target population. An evaluation plan is proposed and briefly described. UR - http://games.jmir.org/2019/2/e12429/ UR - http://dx.doi.org/10.2196/12429 UR - http://www.ncbi.nlm.nih.gov/pubmed/31199333 ID - info:doi/10.2196/12429 ER - TY - JOUR AU - Birnie, A. Kathryn AU - Campbell, Fiona AU - Nguyen, Cynthia AU - Lalloo, Chitra AU - Tsimicalis, Argerie AU - Matava, Clyde AU - Cafazzo, Joseph AU - Stinson, Jennifer PY - 2019/04/22 TI - iCanCope PostOp: User-Centered Design of a Smartphone-Based App for Self-Management of Postoperative Pain in Children and Adolescents JO - JMIR Form Res SP - e12028 VL - 3 IS - 2 KW - postoperative pain KW - smartphone KW - mobile applications KW - mHealth KW - pain management KW - self-management KW - adolescent N2 - Background: Moderate to severe postoperative pain in children is common. Increased pediatric day surgeries have shifted postoperative pain management predominantly to the home setting. Mobile health technology has the potential to overcome barriers to pain care by improving access to self-management resources. However, pain apps generally lack scientific evidence and are highly underutilized due to lack of involvement of end users in their development. Thus, an evidence-based pain self-management smartphone app that incorporates the needs and perspective of children and adolescents (end users) has potential to improve postoperative pain management. Objective: This paper aimed to describe how the principles of user-centered design were applied to the development of iCanCope PostOp, a smartphone-based pain self-management app for children and adolescents after surgery. Specifically, it presents 2 completed phases of the user-centered design process (concept generation and ideation) for the iCanCope PostOp app. Methods: Phase 1 was a multisite needs assessment from the perspective of 19 children and adolescents who had undergone various day surgeries, 19 parents, and 32 multidisciplinary health care providers. Children, adolescents, and parents completed individual semistructured interviews, and health care providers participated in focus groups. Data were summarized using qualitative content analysis. Phase 2 developed a pain care algorithm for the app using Delphi surveys and a 2-day in-person design workshop with 11 multidisciplinary pediatric postoperative pain experts and 2 people with lived experience with postoperative pain. Results: Phase 1 identified self-management challenges to postoperative pain management and recovery; limited available resources and reliance on medications as a predominant postoperative pain management strategy; and shared responsibility of postoperative pain care by children and adolescents, parents, and health care providers. Key app functions of tracking pain, pain self-management strategies, and goal setting were identified as priorities. Phase 2 led to the successful and efficient generation of a complete preliminary pain care algorithm for the iCanCope PostOp app, including clinically relevant inputs for feasible assessment and reassessment of pain and function (rest or sleep, movement or play, and mood or worry), as well as a catalog of pain management advice to be pushed to end users (psychological, physical, pharmacological, and education). Conclusions: The concept ideation and generation phases of the user-centered design approach were successfully completed for the iCanCope PostOp app. Next steps will include design finalization, app development (iOS or Android), evaluation through a randomized controlled trial, and subsequent implementation of the iCanCope PostOp app in clinical care. UR - http://formative.jmir.org/2019/2/e12028/ UR - http://dx.doi.org/10.2196/12028 UR - http://www.ncbi.nlm.nih.gov/pubmed/31008704 ID - info:doi/10.2196/12028 ER - TY - JOUR AU - Chen, T. Annie AU - Swaminathan, Aarti AU - Kearns, R. William AU - Alberts, M. Nicole AU - Law, F. Emily AU - Palermo, M. Tonya PY - 2019/04/15 TI - Understanding User Experience: Exploring Participants? Messages With a Web-Based Behavioral Health Intervention for Adolescents With Chronic Pain JO - J Med Internet Res SP - e11756 VL - 21 IS - 4 KW - data visualization KW - natural language processing KW - chronic pain KW - cluster analysis KW - technology N2 - Background: Delivery of behavioral health interventions on the internet offers many benefits, including accessibility, cost-effectiveness, convenience, and anonymity. In recent years, an increased number of internet interventions have been developed, targeting a range of conditions and behaviors, including depression, pain, anxiety, sleep disturbance, and eating disorders. Human support (coaching) is a common component of internet interventions that is intended to boost engagement; however, little is known about how participants interact with coaches and how this may relate to their experience with the intervention. By examining the data that participants produce during an intervention, we can characterize their interaction patterns and refine treatments to address different needs. Objective: In this study, we employed text mining and visual analytics techniques to analyze messages exchanged between coaches and participants in an internet-delivered pain management intervention for adolescents with chronic pain and their parents. Methods: We explored the main themes in coaches? and participants? messages using an automated textual analysis method, topic modeling. We then clustered participants? messages to identify subgroups of participants with similar engagement patterns. Results: First, we performed topic modeling on coaches? messages. The themes in coaches? messages fell into 3 categories: Treatment Content, Administrative and Technical, and Rapport Building. Next, we employed topic modeling to identify topics from participants? message histories. Similar to the coaches? topics, these were subsumed under 3 high-level categories: Health Management and Treatment Content, Questions and Concerns, and Activities and Interests. Finally, the cluster analysis identified 4 clusters, each with a distinguishing characteristic: Assignment-Focused, Short Message Histories, Pain-Focused, and Activity-Focused. The name of each cluster exemplifies the main engagement patterns of that cluster. Conclusions: In this secondary data analysis, we demonstrated how automated text analysis techniques could be used to identify messages of interest, such as questions and concerns from users. In addition, we demonstrated how cluster analysis could be used to identify subgroups of individuals who share communication and engagement patterns, and in turn facilitate personalization of interventions for different subgroups of patients. This work makes 2 key methodological contributions. First, this study is innovative in its use of topic modeling to provide a rich characterization of the textual content produced by coaches and participants in an internet-delivered behavioral health intervention. Second, to our knowledge, this is the first example of the use of a visual analysis method to cluster participants and identify similar patterns of behavior based on intervention message content. UR - http://www.jmir.org/2019/4/e11756/ UR - http://dx.doi.org/10.2196/11756 UR - http://www.ncbi.nlm.nih.gov/pubmed/30985288 ID - info:doi/10.2196/11756 ER - TY - JOUR AU - Lalloo, Chitra AU - Hundert, Amos AU - Harris, Lauren AU - Pham, Quynh AU - Campbell, Fiona AU - Chorney, Jill AU - Dick, Bruce AU - Simmonds, Mark AU - Cafazzo, Joseph AU - Stinson, Jennifer PY - 2019/01/17 TI - Capturing Daily Disease Experiences of Adolescents With Chronic Pain: mHealth-Mediated Symptom Tracking JO - JMIR Mhealth Uhealth SP - e11838 VL - 7 IS - 1 KW - adherence KW - adolescents KW - chronic pain KW - disease experience KW - feasibility KW - mHealth KW - self-report KW - smartphones KW - symptom monitoring KW - mobile phone N2 - Background: Chronic pain is a common problem in adolescents that can negatively impact all aspects of their health-related quality of life. The developmental period of adolescence represents a critical window of opportunity to optimize and solidify positive health behaviors and minimize future pain-related disability and impaired work productivity. This research focuses on the development and evaluation of a smartphone-based pain self-management app for adolescents with chronic pain. Objective: The objectives of this study were to characterize (1) the feasibility of deploying a mobile health (mHealth) app (iCanCope) to the personal smartphones of adolescent research participants; (2) adherence to daily symptom tracking over 55 consecutive days; (3) participant interaction with their symptom history; and (4) daily pain-related experiences of adolescents with chronic pain. Methods: We recruited adolescents aged 15-18 years from 3 Canadian pediatric tertiary care chronic pain clinics. Participants received standardized instructions to download the iCanCope app and use it once a day for 55 days. Detailed app analytics were captured at the user level. Adherence was operationally defined as per the relative proportion of completed symptom reports. Linear mixed models were used to examine the trajectories of daily symptom reporting. Results: We recruited 60 participants between March 2017 and April 2018. The mean age of the participants was 16.4 (SD 0.9) years, and 88% (53/60) of them were female. The app was deployed to 98% (59/60) devices. Among the 59 participants, adherence was as follows: low (4, 7%), low-moderate (14, 24%), high-moderate (16, 27%), and high (25, 42%). Most (49/59, 83%) participants chose to view their historical symptom trends. Participants reported pain intensity and pain-related symptoms of moderate severity, and these ratings tended to be stable over time. Conclusions: This study indicates that (1) the iCanCope app can be deployed to adolescents? personal smartphones with high feasibility; (2) adolescents demonstrated moderate-to-high adherence over 55 days; (3) most participants chose to view their symptom history; and (4) adolescents with chronic pain experience stable symptomology of moderate severity. Trial Registration: ClinicalTrials.gov NCT02601755; https://clinicaltrials.gov/ct2/show/NCT02601755 (Archived by WebCite at http://www.webcitation.org/74F4SLnmc) UR - http://mhealth.jmir.org/2019/1/e11838/ UR - http://dx.doi.org/10.2196/11838 UR - http://www.ncbi.nlm.nih.gov/pubmed/30664472 ID - info:doi/10.2196/11838 ER - TY - JOUR AU - Tougas, E. Michelle AU - Chambers, T. Christine AU - Corkum, Penny AU - Robillard, M. Julie AU - Gruzd, Anatoliy AU - Howard, Vivian AU - Kampen, Andrea AU - Boerner, E. Katelynn AU - Hundert, S. Amos PY - 2018/12/11 TI - Social Media Content About Children?s Pain and Sleep: Content and Network Analysis JO - JMIR Pediatr Parent SP - e11193 VL - 1 IS - 2 KW - child health KW - knowledge translation KW - pain KW - sleep KW - social media N2 - Background: Social media is often used for health communication and can facilitate fast information exchange. Despite its increasing use, little is known about child health information sharing and engagement over social media. Objective: The primary objectives of this study are to systematically describe the content of social media posts about child pain and sleep and identify the level of research evidence in these posts. The secondary objective is to examine user engagement with information shared over social media. Methods: Twitter, Instagram, and Facebook were searched by members of the research team over a 2-week period using a comprehensive search strategy. Codes were used to categorize the content of posts to identify the frequency of content categories shared over social media platforms. Posts were evaluated by content experts to determine the frequency of posts consistent with existing research evidence. User engagement was analyzed using Netlytic, a social network analysis program, to examine visual networks illustrating the level of user engagement. Results: From the 2-week period, nearly 1500 pain-related and 3800 sleep-related posts were identified and analyzed. Twitter was used most often to share knowledge about child pain (639/1133, 56.40% of posts), and personal experiences for child sleep (2255/3008, 75.00% of posts). For both topics, Instagram posts shared personal experiences (53/68, 78% pain; 413/478, 86.4% sleep), Facebook group posts shared personal experiences (30/49, 61% pain; 230/345, 66.7% sleep) and Facebook pages shared knowledge (68/198, 34.3% pain; 452/1026, 44.05% sleep). Across platforms, research evidence was shared in 21.96% (318/1448) of pain- and 9.16% (445/4857) of sleep-related posts; 5.38% (61/1133) of all pain posts and 2.82% (85/3008) of all sleep posts shared information inconsistent with the evidence, while the rest were absent of evidence. User interactions were indirect, with mostly one-way, rather than reciprocal conversations. Conclusions: Social media is commonly used to discuss child health, yet the majority of posts do not contain research evidence, and user engagement is primarily one-way. These findings represent an opportunity to expand engagement through open conversations with credible sources. Research and health care communities can benefit from incorporating specific information about evidence within social media posts to improve communication with the public and empower users to distinguish evidence-based content better. Together, these findings have identified potential gaps in social media communication that may be informative targets to guide future strategies for improving the translation of child health evidence over social media. UR - http://pediatrics.jmir.org/2018/2/e11193/ UR - http://dx.doi.org/10.2196/11193 UR - http://www.ncbi.nlm.nih.gov/pubmed/31518292 ID - info:doi/10.2196/11193 ER - TY - JOUR AU - Hollier, M. John AU - Vaughan, O. Adetola AU - Liu, Yan AU - van Tilburg, AL Miranda AU - Shulman, J. Robert AU - Thompson, I. Debbe PY - 2018/06/29 TI - Maternal and Child Acceptability of a Proposed Guided Imagery Therapy Mobile App Designed to Treat Functional Abdominal Pain Disorders in Children: Mixed-Methods Predevelopment Formative Research JO - JMIR Pediatr Parent SP - e6 VL - 1 IS - 1 KW - functional abdominal pain disorders KW - guided imagery therapy KW - mixed methods KW - mobile applications KW - pediatrics KW - parents KW - Technology Acceptance Model KW - imagery (psychotherapy) N2 - Background: Functional abdominal pain disorders are chronic abdominal pain conditions, which affect up to 20% of children worldwide. Of the various functional abdominal pain disorder treatment modalities, psychological therapies such as guided imagery therapy appear most effective. However, there are significant barriers to receiving psychological therapies, including access to trained therapists. Alternatively, remotely delivered psychological therapies for functional abdominal pain disorders have been efficacious. Objective: The objective of our study was to assess acceptability of a proposed guided imagery therapy app designed to treat functional abdominal pain disorders through remote delivery of prerecorded audio sessions and to evaluate user preferences for using such an app. Methods: Using a mixed-methods approach, we conducted a predevelopment formative study among children aged 7 to 12 years with a functional abdominal pain disorder and their parents. The parents completed our modified Technology Acceptance Model (TAM) questionnaire, which quantified behavioral intention and related factors for using a guided imagery therapy app. Dyads participated in separate in-person semistructured interviews to assess their attitudes toward and preferences for a guided imagery therapy app. Questionnaire and interview findings were collected concurrently, analyzed separately, and then integrated through methods triangulation. Results: Among the 15 participating parent-child dyads, 5 (33%) children were Hispanic and 11 (73%) had irritable bowel syndrome. They had diverse socioeconomic status. All parent participants were mothers. The TAM questionnaire indicated that mothers scored favorably on behavioral intention to use a guided imagery therapy app (mean score 12.0, SD 2.6, possible range 3-15). Scores for the TAM factors perceived usefulness, perceived ease of use, hedonic motivation, compatibility, and habit also were favorable. Maternal interviews confirmed positive attitudes toward the proposed app. They advocated a visual component to hold their child?s attention during the guided imagery therapy sessions; recommended incorporating background sounds into the sessions; favored session reminder notifications from the app; and thought the best time for their child to listen to the sessions would be in the evening or before bed. The child interviews also confirmed positive attitudes toward the proposed app. They suggested guided imagery therapy session topics such as sports and adventures; listening to sessions in their bedroom; and the need for parental supervision to install the app on their mobile device. Integration of the quantitative and qualitative methods findings complimented one another on acceptability. The favorable behavioral intention TAM score aligned well with expressed positive maternal and child attitudes toward the app and can be explained by the desire to avoid medications. The questionnaire and interviews also confirmed therapeutic benefit as an intrinsic motivator to promote routine use. Conclusions: A guided imagery therapy app designed to treat pediatric patients with functional abdominal pain disorders appears to be acceptable to both mothers and children. Incorporating parent and child preferences into a guided imagery therapy app could promote therapeutic compliance and increase access to optimal care. UR - http://pediatrics.jmir.org/2018/1/e6/ UR - http://dx.doi.org/10.2196/pediatrics.8535 UR - http://www.ncbi.nlm.nih.gov/pubmed/31518303 ID - info:doi/10.2196/pediatrics.8535 ER - TY - JOUR AU - Jibb, A. Lindsay AU - Stevens, J. Bonnie AU - Nathan, C. Paul AU - Seto, Emily AU - Cafazzo, A. Joseph AU - Johnston, L. Donna AU - Hum, Vanessa AU - Stinson, N. Jennifer PY - 2018/04/06 TI - Perceptions of Adolescents With Cancer Related to a Pain Management App and Its Evaluation: Qualitative Study Nested Within a Multicenter Pilot Feasibility Study JO - JMIR Mhealth Uhealth SP - e80 VL - 6 IS - 4 KW - pain KW - adolescent KW - cancer KW - supportive care KW - mHealth KW - qualitative N2 - Background: Pain in adolescents with cancer is common and negatively impacts health-related quality of life. The Pain Squad+ smartphone app, capable of providing adolescents with real-time pain management support, was developed to enhance pain management using a phased approach (ie, systematic review, consensus conference and vetting, iterative usability testing cycles). A 28-day Pain Squad+ pilot was conducted with 40 adolescents with cancer to evaluate the feasibility of implementing the app in a future clinical trial and to obtain estimates of treatment effect. Objective: The objective of our nested qualitative study was to elucidate the perceptions of adolescents with cancer to determine the acceptability and perceived helpfulness of Pain Squad+, suggestions for app improvement, and satisfaction with the pilot study protocol. Methods: Post pilot study participation, telephone-based, semistructured, and audio-recorded exit interviews were conducted with 20 adolescents with cancer (12-18 years). All interviews were transcribed and independently coded by 2 study team members. Content analysis was conducted to identify data categories and overarching themes. Results: Five major themes comprising multiple categories and codes emerged. These themes focused on the acceptability of the intervention, acceptability of the study, the perceived active ingredients of the intervention, the suitability of the intervention to adolescents? lives, and recommendations for intervention improvement. Conclusions: Overall, Pain Squad+ and the pilot study protocol were acceptable to adolescents with cancer. Suggestions for intervention and study improvements will be incorporated into the design of a future randomized clinical trial (RCT) aimed at assessing the effectiveness of Pain Squad+ on adolescents with cancer health outcomes. UR - http://mhealth.jmir.org/2018/4/e80/ UR - http://dx.doi.org/10.2196/mhealth.9319 UR - http://www.ncbi.nlm.nih.gov/pubmed/29625951 ID - info:doi/10.2196/mhealth.9319 ER - TY - JOUR AU - Lalouni, Maria AU - Ljótsson, Brjánn AU - Bonnert, Marianne AU - Hedman-Lagerlöf, Erik AU - Högström, Jens AU - Serlachius, Eva AU - Olén, Ola PY - 2017/08/10 TI - Internet-Delivered Cognitive Behavioral Therapy for Children With Pain-Related Functional Gastrointestinal Disorders: Feasibility Study JO - JMIR Ment Health SP - e32 VL - 4 IS - 3 KW - cognitive therapy KW - behavior therapy KW - functional gastrointestinal disorders KW - abdominal pain KW - irritable bowel syndrome N2 - Background: Pain-related functional gastrointestinal disorders (P-FGIDs; eg, irritable bowel syndrome) are highly prevalent in children and associated with low quality of life, anxiety, and school absence. Treatment options are scarce, and there is a need for effective and accessible treatments. Internet-delivered cognitive behavior therapy (Internet-CBT) based on exposure exercises is effective for adult and adolescent irritable bowel syndrome, but it has not been evaluated for younger children. Objective: The objective of this study was to assess acceptability, feasibility, and potential clinical efficacy of Internet-CBT for children with P-FGIDs. Methods: This was a feasibility study with a within-group design. We included 31 children aged 8-12 years and diagnosed with P-FGID, according to the ROME III criteria. Mean duration of abdominal symptoms at baseline was 3.8 years (standard deviation [SD] 2.6). The treatment was therapist-guided and consisted of 10 weekly modules of exposure-based Internet-CBT. The children were instructed to provoke abdominal symptoms in a graded manner and to engage in previously avoided activities. The parents were taught to decrease their attention to their children?s pain behaviors and to reinforce and support their work with the exposures. Assessments included treatment satisfaction, subjective treatment effect, gastrointestinal symptoms, quality of life, pain intensity, anxiety, depression, and school absence. Data were collected at pretreatment, posttreatment, and 6-month follow-up. Means, standard errors (SEs), and Cohen d effect sizes were estimated based on multi-level linear mixed models. Results: Most children 25/31 (81%) completed 9 or 10 of the 10 treatment modules. Almost all children, 28/31 (90%), reported that the treatment had helped them to deal more effectively with their symptoms, and 27/31 (87%) children declared that their symptoms had improved during the treatment. Assessments from the parents were in accordance with the children?s reports. No child or parent reported that the symptoms had worsened. We observed a large within-group effect size on the primary outcome measure, child-rated gastrointestinal symptoms from pretreatment to posttreatment (Cohen d=1.14, P<.001, 95% CI 0.69-1.61), and this effect size was maintained at 6-month follow-up (Cohen d=1.40, P<.001, 95% CI 1.04-1.81). We also observed significant improvements from pretreatment to posttreatment on a wide range of child- and parent-rated measures including quality of life, pain intensity, anxiety, depression, and school absence. All results remained stable or were further improved at 6-month follow-up. Conclusions: This study shows that children with longstanding P-FGIDs, and their parents, perceive exposure-based Internet-CBT as a helpful and feasible treatment. The included children improved significantly despite a long duration of abdominal symptoms before the intervention. The treatment shows potential to be highly effective for P-FGIDs. The results need to be confirmed in a randomized controlled trial (RCT). UR - http://mental.jmir.org/2017/3/e32/ UR - http://dx.doi.org/10.2196/mental.7985 UR - http://www.ncbi.nlm.nih.gov/pubmed/28798012 ID - info:doi/10.2196/mental.7985 ER - TY - JOUR AU - Stinson, N. Jennifer AU - Jibb, A. Lindsay AU - Nguyen, Cynthia AU - Nathan, C. Paul AU - Maloney, Marie Anne AU - Dupuis, Lee L. AU - Gerstle, Ted J. AU - Alman, Benjamin AU - Hopyan, Sevan AU - Strahlendorf, Caron AU - Portwine, Carol AU - Johnston, L. Donna AU - Orr, Mike PY - 2013/03/08 TI - Development and Testing of a Multidimensional iPhone Pain Assessment Application for Adolescents with Cancer JO - J Med Internet Res SP - e51 VL - 15 IS - 3 KW - neoplasms KW - pain KW - child KW - adolescent KW - youth KW - cellular phone KW - game N2 - Background: Pain is one of the most common and distressing symptoms reported by adolescents with cancer. Despite advancements in pain assessment and management research, pain due to cancer and/or its treatments continues to be poorly managed. Our research group has developed a native iPhone application (app) called Pain Squad to tackle the problem of poorly managed pain in the adolescent with cancer group. The app functions as an electronic pain diary and is unique in its ability to collect data on pain intensity, duration, location, and the impact pain has on an adolescent?s life (ie, relationships, school work, sleep, mood). It also evaluates medications and other physical and psychological pain management strategies used. Users are prompted twice daily at configurable times to complete 20 questions characterizing their pain and the app transmits results to a database for aggregate reporting through a Web interface. Each diary entry represents a pain case filed by an adolescent with cancer and a reward system (ie, moving up through law-enforcement team ranks, built-in videotaped acknowledgements from fictitious officers) encourages consistent use of the diary. Objective: Our objective was to design, develop, and test the usability, feasibility, compliance, and satisfaction of a game-based smartphone pain assessment tool for adolescents with cancer. Methods: We used both low- and high-fidelity qualitative usability testing with qualitative semi-structured, audio-taped interviews and iterative cycles to design and refine the iPhone based Pain Squad app. Qualitative thematic analysis of interviews using constant comparative methodology captured emergent themes related to app usability. Content validity was assessed using question importance-rating surveys completed by participants. Compliance and satisfaction data were collected following a 2-week feasibility trial where users were alarmed to record their pain twice daily on the app. Results: Thematic analysis of usability interviews showed the app to be appealing overall to adolescents. Analyses of both low- and high-fidelity testing resulted in minor revisions to the app to refine the theme and improve its usability. Adolescents resoundingly endorsed the game-based nature of the app and its virtual reward system. The importance of app pain diary questions was established by content validity analysis. Compliance with the app, assessed during feasibility testing, was high (mean 81%, SD 22%) and adolescents from this phase of the study found the app likeable, easy to use, and not bothersome to complete. Conclusions: A multifaceted usability approach demonstrated how the Pain Squad app could be made more appealing to children and adolescents with cancer. The game-based nature and built-in reward system of the app was appealing to adolescents and may have resulted in the high compliance rates and satisfaction ratings observed during clinical feasibility testing. UR - http://www.jmir.org/2013/3/e51/ UR - http://dx.doi.org/10.2196/jmir.2350 UR - http://www.ncbi.nlm.nih.gov/pubmed/23475457 ID - info:doi/10.2196/jmir.2350 ER -