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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.
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.
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.
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 (
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.
ClinicalTrials.gov NCT03686176; https://clinicaltrials.gov/ct2/show/NCT03686176
Venipuncture is a common pediatric emergency department procedure; yet, optimal psychological interventions to promote coping remain undetermined. Standard of care ranges from no intervention to certified child life specialist support with use of a variety of cognitive or behavioral strategies. Data on virtual reality (VR) have overall demonstrated improved pediatric pain and anxiety during venipuncture [
We conducted a pilot study to understand the feasibility of conducting a trial with a commercially available VR headset 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. The results of this study provide preliminary data for the planning of subsequent studies.
A convenience sample of patients aged 7-22 years who required a painful procedure (eg, venipuncture, laceration repair, burn debridement) in the pediatric emergency department were recruited. The study design was a stratified, randomized, controlled pilot trial that compared coping and distress between child life specialist–supported VR engagement and child life specialist support (clinicaltrials.gov NCT03686176). This study was conducted in an academic, urban, tertiary care pediatric emergency department. Randomization allocation was 1:1, performed in randomized blocks of 2, 4, 6, and 8 (R, Version 3.2.2, 2018), and stratified by the type of procedure. The block randomization allocation was imported into REDCap (version 10.0.28, 2019) [
Inclusion criteria were patients aged 7-22 years who were in the pediatric emergency department and were undergoing any of the following procedures: burn debridement or dressing change, laceration repair, venipuncture (intravenous line or blood draw), abscess incision and drainage, fracture reduction or cast placement, or implanted central venous port placement. Exclusion criteria included severe developmental delays, seizures, blindness, trauma/infection on the head/face, altered mental status, medical urgency, and non-English speakers. Caregivers provided verbal consent and patients provided verbal assent to participate in the study.
Patient eligibility was screened by research assistants. Eligible patients and caregivers were introduced to the study by research assistants. Research assistants discussed the aims, risks, and benefits of the study, described the VR intervention, and invited patients and caregivers to participate. If consent was obtained, patients were block randomized as described above. Patients randomized to VR played a game using a commercially available VR headset with child life specialist support (
The active control group received child life specialist support and distraction of the child’s choosing. The reference group received no standardized support. During the procedures, an independent evaluator (ie, research assistant) logged the frequency of patient coping/distress and caregiver coping-promoting/distress-promoting behaviors in 1-minute increments by using a validated scale (Child Adult Medical Procedure Interaction Scale-Short Form [CAMPIS-SF],
The primary (feasibility) outcomes were the recruitment rate, defined as the number of patients who enrolled divided by those invited to participate; the withdrawal rate of VR, defined as the number of patients who stopped VR engagement divided by the number of patients who completed a procedure and were randomized to VR; and completion percentage of CAMPIS-SF observations for each patient/caregiver dyad of completed procedures. Feasibility benchmarks for each outcome were set at 80% or higher, and the target sample size for the feasibility outcomes of this pilot trial was at least 12 patients in each arm [
The secondary (clinical) outcomes were CAMPIS-SF coping and distress scores. Coping scores were calculated by summing all coping events divided by the sum of all the coded behaviors exhibited during the procedure and reported as a proportion of the total behaviors (range 0-1.0). Distress scores were calculated similarly—the sum of all distress events divided by the sum of all behavior events. Secondary clinical outcomes also included change in pain and anxiety on a 10-point visual analog scale from baseline to peak levels during the procedure (range –10 to 10) and cybersickness symptoms [
Feasibility outcomes were summarized. Demographics and clinical characteristics and outcomes were compared across groups by using analysis of variance for continuous variables and Fisher exact tests for categorical variables. A
This study was approved by the Johns Hopkins University School of Medicine institutional review board (ID IRB00161331).
The eligibility, enrollment, and randomization procedures are shown in
CONSORT patient flow diagram.
Out of the 71 patients invited to participate, 66 (93%) were recruited and 5 (7%) declined to enroll. Of the 15 patients in this study population who were randomized to VR, 4 patients (27%) withdrew from using VR. Patients who withdrew had issues related to the fit of the headset or distress with a preference to watch the procedure (
Characteristics of the patients who withdrew from the use of virtual reality during pediatric procedures.
Age (years) | Sex | Reason for virtual reality withdrawal | CAMPIS-SFa scores (range 0-1.00) | Visual analog scale (range 0-10) | Cybersickness symptoms | ||
Patient coping | Patient distress | Peak pain | Peak anxiety | ||||
10 | Female | Declined because of poor headset fit and sliding down too much, virtual reality withdrawn before the procedure | 1.00 | 0.00 | 7 | 1 | No |
10 | Female | Distressed during the procedure, removed virtual reality to watch the procedure, withdrew in the middle of the procedure | 0.46 | 0.54 | 5 | 9 | No |
8 | Female | Patient rolling and flailing, virtual reality removed for safety and because the child preferred to see the procedure, withdrew in the middle of the procedure | 0.43 | 0.57 | 10 | 10 | No |
7 | Female | The patient was moving, virtual reality headset was slipping, so virtual reality removed at child life specialists’ and patient discretion, withdrawn near the end of the procedure. | 0.89 | 0.11 | 6 | 3 | No |
aCAMPIS-SF: Child Adult Medical Procedure Interaction Scale-Short Form.
A total of 55 patients undergoing venipuncture comprised the analysis of the clinical outcomes: 15 patients (15 caregivers) were randomized to VR group, 20 patients (15 caregivers) were randomized to child life specialist group, and 20 patients (17 caregivers) were included in the reference group. The mean age of all the patients was 14.1 (SD 4.1) years. Patient demographics were well-balanced across groups (
Patient coping differed across groups with higher coping in VR group and child life specialist group than in the reference group (
Patient demographics for clinical outcomes.
Patient demographics | Reference group | Child life specialist group | Virtual reality group | Total patients | |||
Patients, n (%) | 20 (36) | 20 (36) | 15 (27) | 55 (100) | N/Aa | ||
Age (years), mean (SD) | 14.5 (4.2) | 15.2 (4.0) | 12.1 (3.5) | 14.1 (4.1) | .08 | ||
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.19 | ||||||
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Child (age range 7-9 years) | 4 (20) | 1 (5) | 3 (20) | 9 (15) |
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Early adolescent (age range 10-13 years) | 3 (15) | 7 (35) | 6 (40) | 19 (31) |
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Middle adolescent (age range 14-17 years) | 9 (45) | 5 (25) | 5 (33) | 22 (35) |
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Late adolescent/adult (age ≥18+ years) | 4 (20) | 7 (35) | 1 (7) | 12 (19) |
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.72 | ||||||
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Female | 12 (60) | 12 (60) | 11 (73) | 35 (64) |
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Male | 8 (40) | 8 (40) | 4 (27) | 20 (36) |
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.20 | ||||||
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Black or African American | 11 (55) | 11 (55) | 4 (27) | 26 (47) |
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White | 8 (40) | 7 (35) | 9 (60) | 24 (44) |
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Unknown or not reported | 1 (5) | 2 (10) | 2 (13) | 5 (9) |
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.30 | ||||||
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Hispanic or Latino | 0 (0) | 2 (10) | 2 (13) | 4 (7) |
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Not Hispanic or Latino | 20 (100) | 18 (90) | 13 (87) | 51 (93) |
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aN/A: not applicable.
Clinical outcomes of the patients and caregivers.a
Outcome | Reference group | Child life specialist group | Virtual reality group | |||||
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Patients (N=55), n (%) | 20 (36) | 20 (36) | 15 (27) | N/Ab | |||
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Patient coping score | 0.70 (0.39) | 0.90 (0.14) | 0.88 (0.19) | .046c | ||
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Patient distress score | 0.20 (0.31) | 0.10 (0.14) | 0.12 (0.19) | .36 | ||
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Pain | 0.95 (2.35) | –1.20 (4.16) | –0.20 (4.31) | .19 | ||
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Anxiety | 1.45 (3.32) | –0.10 (1.74) | 0.53 (2.77) | .20 | ||
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Topical anesthetic used, n (%) | 1 (5) | 2 (10) | 2 (13) | .21 | |||
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.37 | ||||||
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Before virtual reality use | N/A | N/A | 3 (20) |
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After virtual reality use | N/A | N/A | 3 (20) |
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Caregivers, n (%) | 17 (36) | 15 (32) | 15 (32) | N/A | |||
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Caregiver coping promoting score | 0.57 (0.43) | 0.52 (0.48) | 0.63 (0.38) | .76 | ||
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Caregiver distress promoting score | 0.20 (0.31) | 0.08 (0.20) | 0.24 (0.30) | .28 | ||
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Caregiver’s perception of patient’s pain | 0.00 (2.52) | –2.47 (3.50) | –1.73 (3.49) | .09 | ||
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Caregiver’s perception of patient’s anxiety | 1.29 (2.47) | –1.60 (2.64) | –0.53 (3.85) | .03c | ||
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Caregiver’s own anxiety | 0.35 (1.32) | –0.73 (2.22) | –0.13 (3.09) | .41 |
aChange in pain and anxiety scores ranges from –10 to 10. A negative value signifies reduced pain or anxiety during the procedure.
bN/A: not applicable.
cSignificant at
This study found that real-time objective behavior observations of patient and caregiver coping were feasible to perform in a study of VR use in the pediatric emergency department. The addition of objective behavioral observations in this study is a novel addition within the VR literature and may provide a complementary endpoint for future VR studies. Observations of patients’ behavior during medical procedures offer rich objective data that can support past studies on the effectiveness of VR on pain and anxiety [
Distraction is a psychological intervention that is effective at reducing pain in children undergoing needle-based interventions [
Our protocol offered VR to children as young as 7 years. Other study protocols that used standard-sized VR headsets included children as young as 7-10 years [
Another novel aspect of this protocol was the observation of caregiver behaviors during pediatric VR use. Caregivers’ comments and actions (eg, reassuring comments, apology, or empathetic statements) are well described antecedents of children’s distress [
This pilot study has several limitations. First, as this was a pilot study, we were not powered to detect clinically meaningful differences in several patient outcomes. Furthermore, owing to the nature of the study interventions, blinding was not possible for patients or study personnel. Thus, the effect of the novelty of VR or biases through informed consent may have influenced the clinical outcomes (eg, objective coping/distress or subjective self-reported pain/anxiety). Nevertheless, we have demonstrated that the collection of observational measures during VR is feasible and results obtained from this study provide important preliminary data for the design of larger interventional investigations. Next, owing to pediatric emergency department procedures, child life specialists were present to support children during VR use. Therefore, it is not possible to separate the effect of child life specialists from VR, and this is of particular concern for the patients who discontinued VR. This can also limit generalizability to clinical sites that use VR without child life specialists present. Of note, the procedures were not video recorded for later reviews and accordingly, intraobserver reliability of the evaluators was not calculated after their training period. For a future large-scale study using CAMPIS-SF, recordings of the procedures could be included in the protocol to ensure evaluator consistency. Finally, we found that an individual who was not performing the venipuncture procedure was needed to support VR use. This may have broader implications for scalability of VR use as child life specialists assisted patients with the fitting of the VR headset, navigation of menus or games, helped remove the headset urgently when it was not tolerated, and observed for cybersickness symptoms.
The findings of this study demonstrate that real-time documentation of observed behaviors in pediatric patients and caregivers is feasible in a study protocol evaluating VR during medical procedures, particularly with sufficient research staff for recruitment. Better coping was observed in children receiving VR or child life specialist support during venipuncture procedures. Further studies including children/early adolescents is warranted to fully evaluate the benefits of VR on pediatric coping and on the child-caregiver dynamics.
Child adult medical procedure interaction scale-short form codes.
CONSORT-EHEALTH checklist (V. 1.6.1).
Child Adult Medical Procedure Interaction Scale-Short Form
virtual reality
This work was supported by the Thomas Wilson Foundation, Baltimore, MD. Anna Biddle, Patrice Brylske, and Peyton Pike contributed to the development of the research protocol. The research protocol and individual participant data that underlie the results reported in this paper after deidentification are accessible on clinicaltrials.gov.
The following authors have made substantial contributions to the content of this manuscript. TC, CP, AS, KK, and JM conceptualized this study. The methodology was performed by TC, CP, CS, AS, KK, KP, and JM. AB and KP performed formal analysis, while TC, CS, AB, and AS performed the investigations. Resources were provided by TC and AS, and data were curated by TC, CS, and AB. The original draft was written by TC, CS, and AB. TC, CP, CS, AB, AS, KK, KP, and JM wrote, reviewed, and edited the manuscript. Visualization was performed by TC, CS, and AB, while supervision was performed by CP and JM. The project was administered by CS and AB, and funds were acquired by TC, CP, AS, KK, and JM.
TC is the CEO and Founder of CurieDx, a medical software company. This company's work is unrelated to the content described in the present manuscript. The other authors have no conflicts of interest to declare.