Summary of the Study
This study synthesized evidence from 38 randomized controlled trials (RCTs) examining the analgesic effects of music intervention (MI) for pediatric pain management. Ting (et al., 2022) defined MI as an intervention that includes rhythm, melody and harmony delivered by a therapist or provider. Ting (et al., 2022) included 5601 total participants under age 18 experiencing various types of acute or chronic pain.
Ting (et al., 2022) found that overall, MI significantly reduced self-reported pain levels, with a medium standardized mean difference (SMD) of -0.57 (95% CI -0.87 to -0.27, p<0.001). This indicates a moderate clinically relevant effect size. According to Ting (et al., 2022), MI also improved physiological indicators of pain, including stabilizing heart rate (SMD=-0.50), respiratory rate (SMD=-0.60) and oxygen saturation (SMD=0.44). However, it did not influence blood pressure (p=0.063). Subgroup analyses provided more detailed evidence. MI relieved pain in newborns (SMD=-0.75) and infants/children (SMD=-0.44), but evidence in adolescents was insufficient. It also reduced chronic, procedural and postoperative pain. Classical music produced the greatest pain reduction (SMD=-0.71), followed by kids’ and pop music (Ting et al., 2022). Music delivery via headphones, earphones or speakers worked well, but live music showed no effect.
Was the development and implementation of the intervention described in detail?
Ting (et al., 2022) provided detailed descriptions of MI interventions implemented across the 38 RCTs. Ting (et al., 2022) systematically extracted key data on the MI methods, music styles, equipment used to deliver music and other intervention details. Table 1 displays this information for each trial. Ting (et al., 2022) also summarized the number of trials utilizing different music types and delivery modalities. This level of detail offers valuable insights into the specifics of the interventions being tested rather than broad categorizations.
Based on a theoretical framework?
Ting (et al., 2022) briefly mentioned theories about how MIs may provide distraction, prompt emotional regulation, and induce relaxation to relieve pain. However, the included trials did not need to base their MI approach explicitly on a specified theoretical framework. Future research might benefit from grounding MI design and hypotheses in behavioural and neurophysiological theories regarding pain perception versus coping responses. Drawing from theories such as the Gate Control Theory could be important. For instance, the Gate Control Theory suggests that music can reduce or manage pain because of its ability to affect the emotional and physiological aspects of pain (Ropero Peláez & Taniguchi, 2016). Linking mechanisms of action to intervention components can enhance the interpretation of results and guide refinement.
Did the study’s design promote investigation of the effects of the study—for example, was there a comparison of experimental and control groups?
Restricting eligibility to RCTs ensured the included studies employed a rigorous experimental design to determine cause-effect relationships between MIs and pediatric pain outcomes (Ting et al., 2022). The vast majority were parallel-group RCTs comparing MI versus non-MI control groups. By meta-analyzing standardized mean differences between groups, the effects of the intervention itself could be isolated (Ting et al., 2022).). Subgroup analysis by pain type, music genre and delivery method further illuminated which intervention factors modified treatment effects (Ting et al., 2022). Limiting to RCTs also minimized the influence of confounding variables. The design and the meta-analytic approach enabled compelling quantification of MI efficacy for alleviating children’s pain under controlled conditions (Ting et al., 2022).
Were there variables not part of the intervention that could have impacted the findings?
While the RCT study design helped reduce confounding, the authors recognize some variables may still have partially influenced results. First, individual music preferences likely affected how engaging or soothing children perceived the MI, especially in adolescents. The preferred music genre would enhance relaxation. Second, some studies employed multimodal interventions, utilizing pharmacologic analgesics alongside MI. Isolating MI’s additive impact is difficult. Third, most studies could not successfully blind participants or personnel administering MI. Awareness of the assigned intervention arm may have introduced bias in outcome assessment or reporting. Researchers need improved sham controls and double-masked protocols.
Was there evidence of efforts to monitor the safety of participants?
Ting (et al., 2022) did not report whether the included studies documented any adverse events, discontinuations or efforts taken to monitor participant safety. Although MI is very low risk, tracking safety parameters demonstrates methodological thoroughness and ethical rigour. Safety outcomes should be discussed in systematic reviews, even for benign interventions. Ensuring children complete interventions without harm is imperative, so reviewing this data and noting its absence provides useful information about potential clinical applications.
Could the study have been improved?
Ting (et al., 2022) suggested excellent improvements for upcoming RCTs testing pediatric pain management with MI. Firstly, larger, more homogeneous samples would enhance generalizability to varied populations. Many included trials have less than 50 participants; limited sample size reduces precision and power. Secondly, double-masked protocols should be implemented whenever feasible to minimize the risk of biased outcome assessment or reporting based on pre-existing beliefs about MI efficacy. Thirdly, collecting and reporting safety data should become standard practice even in low-risk MI trials to uphold ethical diligence and enable risk-benefit appraisal. Fourthly, endeavours should be made to increase the standardization of pain measurement scales across similar trials to facilitate comparison and meta-analysis of specific clinical indications. Finally, more high-quality RCTs focused distinctly on adolescents are needed to fill the evidence gap for this demographic. However, while select shortcomings exist in the current literature, Ting (et al., 2022) systematic review and meta-analysis demonstrated that MIs could provide an effective non-pharmacological approach to managing many types of pediatric pain. Understanding the influences of developmental stage, music type, delivery method, and measurement tools helps inform appropriate integration into clinical practice.
Study Two: Challenges and Successes of Digital Health Programs for Chronic Disease Management
Summary
This interventional study by Chrysi (et al., 2023) developed and tested a modern web-based health promotion program for patients in Greece with type 2 diabetes and obesity over 12 months. A total of 72 patients meeting eligibility criteria were randomly assigned to either an intervention group that utilized a customized website for education and support (n=36) or a control group (n=36) that received traditional printed health information and infrequent group lectures (Chrysi et al., 2023). Several validated questionnaires were administered at baseline, six months, and 12 months, assessing variables such as patient knowledge, attitudes/beliefs, anxiety/depression levels, and quality of life (Chrysi (et al., 2023). Clinical markers such as BMI, blood glucose, and blood pressure were also evaluated.
The findings showed that patients in the intervention group demonstrated significantly greater improvements across all measures – knowledge scores increased nearly four times higher than controls; attitude scores improved 13.6 points more than controls; anxiety decreased only among the website group; and nearly all quality-of-life indices (physical health, psychological health, social relationships) were higher for the website group (Chrysi (et al., 2023). This proves that a personalized, interactive web-based approach can successfully motivate behaviour change and improve management for chronic health conditions like diabetes and obesity. The modern platform enables tailoring education to individual needs and misconceptions while promoting engagement through technology integration, knowledge games, remote monitoring, and continual contact.
What challenges did the researchers face, and how were these challenges overcome (or not)?
Chrysi (et al., 2023) undertook an ambitious initiative to develop and evaluate a custom web-based health promotion program, which posed several technological and methodological hurdles. Foremost was the need to build an interactive website tailored to the behavioural intervention. This demanded extensive upfront investment in hiring software engineers, drafting educational content across various health topics, filming video tutorials for site navigation, confirming patient login/access protocols, and continual back-end maintenance (Chrysi et al., 2023). The level of IT infrastructure and troubleshooting required could have been more considered early on.
Once the website system was functional, user engagement and participation still needed to be guaranteed (Chrysi et al., 2023). Many patients needed more computer literacy or prior exposure to online health resources. Sustaining consistent website traffic week-to-week was challenging despite enrollment criteria requiring device access. Various promoter features were integrated, like personalized health games, weekly email reminders, monitoring site analytics to identify lapsed users, and setting achievable interaction expectations at only 15 minutes across two logins per week (Chrysi et al., 2023). Still, maximizing adherence in digital self-directed programs remains an obstacle.
All health behaviour studies face threats to validity from biases, especially self-reported data. Patient surveys and questionnaires carry risks of exaggeration, selective memory, or misinterpreted questions (Chrysi et al., 2023). However, using validated instruments and comparisons between groups with different intervention exposures helps strengthen confidence that observed knowledge/attitude differences resulted from online education rather than selection or reporting issues (Krantz et al. 2019). However, objective clinical data could have supplemented self-perceived health patterns.
Moreover, the COVID-19 pandemic arose during implementation, severely limiting the healthcare system’s capacity (Chrysi et al., 2023). However, the web-based program afforded continued patient engagement and support amidst office visit declines. This crisis highlighted the need for telehealth and remote chronic disease management when access barriers exist (Chrysi et al., 2023). However, the small sample size (n=72) did impact statistical power to detect smaller effect sizes. Multi-centre collaborative studies would enhance precision.
How could future research efforts be improved?
Firstly, expanded sample sizes with multiple Greek clinics would better represent population variation in usage, internet access parity, and age effects and improve generalizability (Andrade, 2020). If superiority to standard education persists across larger groups, it supports mainstream adoption. Besides, following patient health status for 2-5 years can evaluate long-term knowledge retention and clinical indicator trajectories after the intervention ceases. Sustained impact over longer periods, not just 12 months, is ideal to combat chronic disease progression (Cuzick, 2023).
Moreover, supplementing patient self-reported health patterns with objective data like blood biomarkers, vital sign changes, body composition analyzers, and cardiorespiratory fitness provides validating evidence aligned to medical standards, not just survey instruments prone to bias.
Enhancing website features can continually refine patient experience – whether integrating mobile app platforms to complement desktop access, virtual discussion forums for social support, video tutorials on proper injection techniques, or informational infographic downloads for reference. Lastly, cost-effectiveness and qualitative participant feedback should guide site refinements and evaluate implementation barriers to eventual payer coverage determinations or institutional purchasing decisions.
Population Estimates
References
Andrade, C. (2020). Sample size and its importance in research. Indian journal of psychological medicine, 42(1), 102-103. https://doi.org/10.4103%2FIJPSYM.IJPSYM_504_19
Chrysi, M. S., Michopoulos, I., Dimitriadis, G., & Peppa, M. (2023). A modern web-based health promotion program for patients in Greece with diabetes two and obesity: an interventional study. BMC Public Health, 23(1), 1-9. https://doi.org/10.1186/s12889-023-15557-3
Cuzick, J. (2023). The importance of long-term follow-up of participants in clinical trials. British journal of cancer, 128(3), 432-438. https://doi.org/10.1038/s41416-022-02038-4
Krantz, E., Wide, U., Trimpou, P., Bryman, I., & Landin-Wilhelmsen, K. (2019). Comparison between different instruments for measuring health-related quality of life in a population sample, the WHO MONICA Project, Gothenburg, Sweden: an observational, cross-sectional study. BMJ open, 9(4), e024454. https://doi.org/10.1136%2Fbmjopen-2018-024454
Ropero Peláez, F. J., & Taniguchi, S. (2016). The gate theory of pain revisited: modelling different pain conditions with a parsimonious neurocomputational model. Neural Plasticity, 2016. https://doi.org/10.1155%2F2016%2F4131395
Ting, B., Tsai, C. L., Hsu, W. T., Shen, M. L., Tseng, P. T., Chen, D. T. L., … & Jingling, L. (2022). Music intervention for pain control in the pediatric population: A systematic review and meta-analysis. Journal of Clinical Medicine, 11(4), 991. https://doi.org/10.3390%2Fjcm11040991
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