Introduction
Globally, an estimated 13.4 million babies are born preterm, which is 9.9% of all births, and this number has been stable over the past decade, with only a minimal decline [1]. Preterm births, defined as delivery before 37 weeks of gestation, are a major cause of newborn mortality and are associated with long-term neurodevelopmental impairments [2-4]. Neurodevelopmental impairments may be triggered through stress responses due to unexpected parent-infant separation and trauma [5], auditory deprivation (eg, lack of exposure to intrauterine maternal heartbeat and the mother’s voice), and the overstimulating, stressful, noisy neonatal intensive care unit (NICU) context [6,7].
The traumatic nature of preterm birth, combined with uncertainties regarding the infant’s health and future and the stressful situation in the NICU, profoundly affects parents as well, resulting in increased rates of anxiety [3,8], depression [3,8], posttraumatic stress [8], and feelings of helplessness [9,10] or disempowerment [11]. Such psychological issues and the physical separation of parents and infants can impact the parent-infant relationship, interaction, and the formation of a secure attachment—an emotional bond, which is formed in the first 18 months of life [3,12] and is associated with the infant’s later socioemotional, behavioral, and cognitive development [3,5,13].
Conversely, in NICUs supporting active parental involvement, such as applying kangaroo-care, improved outcomes have been observed, including reductions in infant mortality and morbidity [14]. This underscores the importance of family-centered care, including free parental access to the NICU and psychological support for parents [15], as well as family-integrating care models with parents being acknowledged as primary caregivers [16].
Building on this foundation, further approaches promoting active parental involvement in the NICU include interventions such as family-integrating creative music therapy (CMT), which emphasizes meaningful multimodal stimulation. CMT uses infant-directed, lullaby-style singing to soothe and gently stimulate infants, while empowering parents through active involvement in the therapeutic process [17-19], that is, music therapy during skin-to-skin contact to foster bidirectional relaxation, attachment, and bonding. Throughout the music therapy process, parents are guided and empowered to recognize their infants’ cues and tailor their responses to the infants’ state and needs, while humming, speaking, and/or singing in a responsive way. CMT is associated with reduced parental stress and anxiety [20,21] and improved neurodevelopmental outcomes [5,18], as well as parent-infant bonding [20]. Moreover, previous systematic reviews demonstrated various beneficial effects of music on physiological parameters such as heart and respiratory rate, oral feeding, behavior, and stress in preterm infants [21,22], and a Cochrane review [23] confirmed an overall substantial beneficial effect of music and vocal interventions on the preterm infants‘ heart rate during and after the intervention. Despite these promising outcomes, access to CMT in NICUs is limited [24] due to the limited availability of therapists [25-27].
One way to address this limited access to CMT in the NICU is the use of mobile health (mHealth) interventions, delivered via an app or SMS text messages. They are increasingly applied in health care delivery and offer major advantages such as cost-effectiveness and accessibility compared to traditional face-to-face interventions and usual care [28-31]. Numerous mHealth interventions for parents exist [32], targeting pregnancy and postpartum care [33-36], parenting [35,37,38], and risk of preterm birth [39,40]. However, there is a notable lack of comprehensive mHealth interventions specifically designed for parents of preterm infants and infants born with serious illness, and, to the best of our knowledge, no music therapy-based mHealth intervention exists.
Another important consideration is that commercially available apps may not have been developed and tested with the same rigor as those created in research settings [41]. This raises concerns about their reliability, feasibility, usability, and real-world impact.
Therefore, a research and development (R&D) project was initiated [42]. It aims to develop a CMT-based mHealth intervention delivered through an app to support, coach, and motivate parents of preterm infants and health care professionals in the NICU and later at home to use their voice and music. This, in turn, will improve well-being and the parent-infant bond. The R&D project is based on a user-centered design (UCD) approach—an iterative process that involves end users throughout the whole development process to continuously refine and reshape the intervention’s design [43,44]. The UCD approach is complemented by a broader human-centered perspective, which considers emotional, social, and contextual realities in which the intervention will be used. This is especially relevant in sensitive settings such as the NICU [45,46].
This study represents the first working package of this project [42], aiming to explore primary (parents) and secondary (health care professionals) end users’ needs and preferences toward such an mHealth intervention. Its overall objective was to provide a basis for further iterative co-design steps, such as developing a prototype of the mHealth intervention, rapid usability testing, effectiveness evaluation, and implementation.
Discussion
Principal Findings
The thematic analysis of participant-generated inputs reveals a broad and multifaceted spectrum of user expectations across parents and professional groups for a CMT-based mHealth intervention as a means toward family-integrated care, which supports, coaches, and motivates parents of preterm infants in neonatal care and at home. Our findings underscore the need to develop digital solutions that focus on promoting parent-infant bonding and empowering parents to both sing to their infants and benefit from the emotional, relational, and developmental advantages of music therapy. Thereby, rather than focusing solely on technical functionalities, participants emphasized a diverse range of needs encompassing a straightforward and inclusive design, educational and motivational content, personalization of functions and content, social support and peer exchange, and features for cross-sectoral long-term use of the mHealth intervention. Health care professionals further stressed the importance of integrating the mHealth intervention in NICU routines to increase its acceptance. These needs reflect a broader understanding of mHealth tools as holistic systems that must consider not only instrumental use but also affective needs to engage users effectively.
The multidimensionality of user expectations beyond technical functionalities has long been recognized in diverse research, for instance on general user needs [53] in the technology acceptance model [54], the unified theory of technology acceptance [55], and in the consumption value theory, which posits that consumer choice is influenced by 5 types of value: functional, conditional, social, emotional, and epistemic [56]. These aspects have gained prominence in research on digital health and mHealth intervention development [57,58] and in the context of mHealth interventions supporting parents during, for instance, pregnancy and postpartum, or in child development [36,59,60]. Most studies agree on the importance of the following components: (1) health promotion, (2) communication—both peer interaction and communication with health care professionals, (3) health tracking, (4) personalization, (5) notifications and reminders, (6) scientific foundation, and (7) patient education [37,41,61].
All these components also emerged as prevalent themes in this study and will be discussed in the following sections, supplemented by a few additional major themes that arose only in our study.
Empowerment and Health Promotion
Most participants expected the app to inform parents about the comprehensive effects of CMT and guide them in using CMT elements to improve their own and their infant’s health actively. The combination of information and actionable instructions was seen as a way to increase motivation and foster a sense of self-efficacy, defined as perceived competence [62,63]. Beyond the anticipated increase in self-efficacy, across multiple themes, participants consistently perceived the mHealth intervention as a tool for empowerment in times of helplessness, with empowerment defined as gaining control over health-related decisions and taking actions [64]. This is particularly relevant in the NICU context, where parents often experience a profound loss of agency, and highlights the value of an intervention that helps parents feel in control of their child’s health and treatment. Indeed, parental empowerment is a key component of CMT [17,65,66]. It empowers parents, for instance, by promoting their sense of agency and self-confidence [17,67], reducing stress [17,20,68], and enhancing well-being, the parent-infant bond, and interaction quality [69,70]. This aligns with and extends the family-integrated care approach, which redefines parents as primary caregivers in the NICU rather than passive observers [16]. A previous randomized controlled trial suggests that this approach leads to improved outcomes for both preterm infants and their parents compared to standard NICU care [16] or even family-centered care [71,72].
However, while some participants of this study perceived the mHealth intervention as a solution to overcome hesitations to sing in a public space, previous research, which also observed this reluctance to sing in the NICU [70], emphasizes the essential role of guidance and support from music therapists. Similarly, other studies identified personal support complementary to the mHealth intervention as 1 out of 4 crucial factors for adherence to these interventions [73]. This suggests that a blended therapy approach might be needed at the beginning of the intervention, with the mHealth intervention complementing face-to-face interventions to receive the advantages from both [74].
Design: Inclusivity, User-Centeredness, and Simplicity
Given the intervention’s intended use across diverse user groups, inclusive design is crucial to ensure accessibility and usability for individuals with different physical, cognitive, and social backgrounds. Moreover, participants highlighted the need for a user-friendly and intuitive design that simplifies interaction.
This is in line with previous research showing that successful technology adoption and uptake depend on perceived costs, such as cognitive costs and self-efficacy beliefs [75,76]. Complex mHealth apps that are complicated to navigate can increase cognitive costs, reduce self-efficacy beliefs, and ultimately reduce the users’ willingness to engage with them.
Functions: Communication, Notifications, and Reminders
Participants clearly preferred an app that includes interactive elements enabling communication with health care professionals and peer-to-peer support. This interest in integrating social interaction and emotional support in mHealth tools aligns with previous studies, which found that both are crucial for engagement in all kinds of mHealth interventions [77,78]. Such features have been shown to foster feelings of support and connectedness, particularly when users perceive that someone has taken the time to send messages and engage with them [79]. Nevertheless, it indicates again that a blended therapy approach might be warranted to preserve the unique benefits of face-to-face communication [74].
Another required function was notifications and reminders. Both are generally seen as helpful for improving user engagement and adherence to mHealth interventions. However, it appears crucial that notifications are tailored to individual progress and specific user needs—for instance, in terms of their schedule and routines, behaviors and preferences—rather than providing generic or frequent alerts, which can become annoying or be ignored [73,80,81]. Furthermore, the reminders’ language has been shown to play a role [80].
Reminders are not the only form of notifications, which might be worth implementing in an mHealth intervention. Preliminary evidence suggests that theory-driven trigger messages based on behavior change theories can have beneficial effects on user engagement by providing reinforcement and targeting motivation, self-efficacy, knowledge, and self-care [81].
Personalization
Personalization emerged as a cross-cutting theme across multiple topics, particularly regarding design and functionalities. For instance, participants would like the app to provide customized content, such as a tailored introduction to and progression through the use of music. This is consistent with other research on mHealth interventions, which shows that personalized designs and functions lead to greater satisfaction, long-term adherence, and effectiveness [73,77,82,83]. Gosetto et al [82] described 4 dimensions of personalization of mHealth: users, system functionalities, information, and app properties. All these aspects were also mentioned by participants, either explicitly or implicitly, in the context of personalization.
Content: Scientific Foundation, Education, and Health Tracking
Regarding content, participants emphasized the importance of providing scientifically validated information to ensure the intervention’s credibility and trustworthiness and, consequently, a reduction of stress. This suggests that participants viewed the app not only as a tool for using music for health but also as a means of transmitting medical and health education. Furthermore, clear instructions and tutorials on how to use the app and interpret the information were seen as crucial for facilitating usability. This finding aligns with previous literature underlining the importance of mHealth interventions with high standards of content quality, ensuring that information is not only accurate but also understandable and actionable (eg, [84]). Additionally, increasing parents’ knowledge on essential aspects of preterm birth can improve their decision-making, which, in turn, affects maternal and infant health [40].
Thereby, to foster adherence to the intervention, it appears especially important to emphasize the positive effects of music therapy [19,52,85] and kangaroo care alone [14] on parents and preterm infants as well as the additional effects stemming from a combination of both [70,86].
Furthermore, incorporating a diary option was frequently mentioned as a valuable tool for parents. This might be explained by the positive impact of narrative diaries in the NICU, which has already been shown [87]. According to a systematic review, these diaries can “improve humanization, communication between NICU staff and parents, parents’ coping, and closeness to their newborn” [87]. A diary as part of an mHealth intervention might have similar promising effects. Another advantage is that they can easily be integrated into existing routines, which, as mentioned above, might enhance an mHealth intervention’s acceptance. Diaries are already implemented in many NICUs and could just be expanded by adding music and sounds next to pictures of the infants.
Sustainability and Long-Term Use
The concept of sustainable, long-term use emerged as another critical topic. Previous research indicates that music therapy generally has potential for long-term use and impact on preterm infants and their families, even after NICU discharge [70,88,89]. For instance, combining music with reading has been shown to improve language development in preterm infants at 2-3 years of age [89], and music became an integral part of their families’ daily life even after supervised interventions ended [70].
Many participants indicated that the long-term use of mHealth interventions depends on the app’s usability across different stages of the child’s development. As mentioned earlier, personalization in the form of tailored, acutely relevant content, functions, and design might play a key role in long-term intervention adherence. Previous research supports the importance of personalized design, functions, and knowledge transfer and adds personal goals as crucial factors for long-term application of mHealth interventions [83].
Therefore, an mHealth intervention integrating music therapy elements, ongoing support, tailored information, personalization, and coaching is likely to enhance the intervention’s sustainability, long-term use, and overall effectiveness.
Acceptance: Addressing Diverse User Needs, Updates, Data Security
Acceptance emerged as a recurring theme, with participants—in particular health care professionals—underscoring the importance of addressing the diverse needs of both parents and clinical staff, particularly given the time constraints faced by the latter. This demonstrates that a human-centered design is imperative, considering the perspectives and daily realities of both as well as the context of use from early on in the design process [45], thereby reinforcing the value of the ECOUTER approach’s participatory principles. In addition, participants expressed the need for regular updates to ensure that the app content remains relevant and engaging. This is also reflected in their desire for continuous improvement and responsiveness to users’ needs. Furthermore, data security was identified as a critical concern. Participants stressed that ensuring privacy and protection of personal health data would significantly influence their willingness to adopt and continue using the app. This aligns with existing literature on digital health adoption, which emphasizes privacy concerns as a considerable barrier to the widespread use of health technologies (eg, [79,90]). Interestingly, in other studies on digital interventions, this concern was not shared by patients or therapists [91], suggesting that perceived risks may vary depending on the type of data involved.
Strengths and Limitations
Given the increasing focus on family-centered and family-integrating care in neonatology, involving family members of preterm infants in developing this mHealth intervention appears crucial for ensuring their needs are met. At the same time, experts from a range of health care professions could contribute valuable expertise and insights into the needs of NICU staff and how a CMT-based intervention may be integrated into the dense and demanding setting of NICUs. Thus, including both groups of participants and the diversity of their roles is a clear strength of this study. Moreover, the large number of contributions, their level of detail and their diversity—reflecting the broad spectrum of perspectives—along with continuous coediting and iterative restructuring led to a comprehensive framework of user needs and preferences for a usable and acceptable mHealth intervention. Saturation was assumed once no new input emerged, and participants confirmed that nothing more could be added. This demonstrates that following the ECOUTER approach was both meaningful and effective. Furthermore, as the approach is based on iterative feedback loops, it allowed us to conduct multiple rounds of participant engagement and to focus on purposeful sampling for the final round, specifically recruiting scientific advisory board members, experts, and parent representatives from premature infant organizations.
However, several limitations of this study should also be acknowledged, primarily related to the study sample. First, while the qualitative design and iterative ECOUTER-informed engagement enabled in-depth exploration and yielded convergent themes across multiple rounds of participant input, the overall sample size was small, which may limit the transferability of the findings. However, the ECOUTER approach facilitated sustained, reflective engagement and enhanced analytic depth, partially mitigating constraints typically associated with single focus group designs [48]. In addition, participants were purposefully selected to represent a range of relevant stakeholder perspectives (including parents, clinicians, music therapists, and psychologists), which strengthened the relevance of findings for intervention development but also resulted in a sample with a high overall educational level. As all participants had completed tertiary education, the perspectives of people with lower socioeconomic status and lower health literacy may be underrepresented, potentially limiting applicability to more socioeconomically diverse populations due to potential differences in information needs, comprehension, and access. Furthermore, participants were recruited from several countries; however, these countries are culturally comparable, and the study did not aim to examine or compare health care systems. While contextual differences may still have influenced individual perspectives, this relative cultural similarity supports thematic coherence. Nonetheless, these factors should be considered when interpreting the findings and applying them to the development of an mHealth intervention for parents.
Second, the questions posed during the focus groups were primarily formulated by FBH. Her professional background and experience as a music therapist in the NICU might have influenced them. However, the question guide was cocreated with other interdisciplinary members of the core research team, and all discussions were held and documented by several interdisciplinary researchers.
Third, this study adopted a real-world, pragmatic approach based on an online collaboration tool. Due to this and anonymization requirements, the contributions on the digital board could not always be attributed to individual participants. Meanwhile, the online format of focus groups may have limited spontaneous, dynamic discussions that are typically seen in in-person settings and are characteristic of group processes. Prior research suggests that virtual focus groups may hinder nuanced dialogues and the ability to pick up nonverbal communication cues (eg, [92,93]). However, these ambiguities were considered a trade-off in favor of the flexibility the online format offers in terms of time and location.
Finally, while stickers allowed participants to visually emphasize certain aspects of the mind map, this method may have created the impression of a consensus or dominant views. Items marked more frequently might be perceived as more important than they are, and it might have biased those prioritizing later. Despite this potential bias, the approach provided valuable insights into participants’ priorities and highlighted the path for future developmental work.
Conclusion and Implications
To our knowledge, this is the first study that provides in-depth insights into the needs, expectations, and concerns of parents and health care professionals regarding a CMT-based mHealth intervention in neonatal care. The NICU—characterized by emotional intensity, parental vulnerability, and clinical pressure—requires particularly sensitive and well-integrated digital solutions. Findings from this study highlight the importance of a user-centered and participatory design approach, engaging diverse user groups, to respond to their individual needs and ensure emotional sensitivity as well as clinical acceptability in the NICU.
The results show that the proposed CMT-based mHealth intervention is seen as a meaningful complement to traditional CMT, which ensures wider access, promotes equity, and fosters parental engagement and empowerment in a situation often marked by helplessness. Key user needs toward the intervention include a simple and inclusive design, personalization, interaction possibilities with health care professionals and peers, and the integration into the daily realities of users. Addressing those needs is critical for the mHealth intervention’s acceptance and effectiveness.
Findings from this study provide a unique, valuable foundation for developing and codesigning the intervention. Subsequently, following a UCD approach, the intervention will be tested for usability, feasibility, and effectiveness, with each research step followed by system refinements before advancing to the next step [42].