Effectiveness of biofeedback therapies in pediatric populations: an umbrella review protocol

Effectiveness of biofeedback therapies in pediatric populations: an umbrella review protocol | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Systematic Review Effectiveness of biofeedback therapies in pediatric populations: an umbrella review protocol Maanya V, Dhananjaya G, Denny John, Ramesh Debur This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8635013/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Objective The objective of this umbrella review is to assess the effectiveness of biofeedback therapies in children and adolescents. Introduction: Biofeedback (BF) is a mind–body therapy that has been shown to produce sustained pain reduction using integrated computerised instruments to provide patients with real-time physiological data. BF teaches patients relaxation skills, instructing them to modify certain behavioural responses (e.g. - slow breathing) to affect physiological changes (e.g. -heart rate) that lead to reduced pain. Inclusion criteria: Systematic reviews, with or without meta-analysis, that examine the effectiveness of biofeedback therapies in children and adolescents will be considered. The review will not be limited to any single medical conditions. The review will be limited to children and adolescents without any physical or mental disability. Methods JBI methods will be used to conduct a comprehensive review and to search evidence sources in MEDLINE (Ovid), Scopus, CINAHL, Cochrane Central, and JBI Evidence Synthesis. Grey and gray literature sources will also be searched, including ProQuest Dissertations and Theses, OAIster, and Google Scholar. The review will focus on works published in english between the creation of the database and the present. Two independent reviewers will assess titles, abstracts, and full texts, and data will be extracted using a custom form. The JBI critical appraisal checklist will be used for the systematic review and research synthesis. The reliability of the evidence regarding the effectiveness of biofeedback therapy will be examined using the GRADE approach Pediatrics Translational Medicine biofeedback pediatrics effectiveness disorders Introduction Managing chronic pain, anxiety disorders, attention-deficit/hyperactivity disorder (ADHD), and psychosomatic diseases in young patients during medical procedures presents a substantial challenge, necessitating the development of novel therapeutic techniques. Biofeedback-assisted relaxation training and virtual reality (VR)-based distraction therapy have emerged as potentially effective treatments for these and other illnesses. Ostojic et al. (2022) conducted a crossover randomized controlled experiment to investigate the efficacy of combining biofeedback-assisted relaxation training with distraction therapy on children undergoing botulinum neurotoxin treatment 1 . In addition to managing pain and anxiety, biofeedback has demonstrated potential in the treatment of other pediatric ailments. A thorough review of biofeedback's clinical uses, such as its use in treating functional gastrointestinal diseases such functional abdominal discomfort, speech and motor problems, and ADHD, is given by Malik and Dua (2023) 2 . Wider medical applications of biofeedback have been demonstrated, highlighting its adaptability in treating ailments like urine incontinence and visual-motor integration impairments in children with cerebral palsy 3 . In order to improve treatment outcomes for illnesses like anxiety and cleft lip and palate, biofeedback has recently been integrated with cutting-edge technology like virtual reality and game-based therapies 4,5,6,7,8 . With its non-invasive and adaptable approach to treating a range of physical and psychological illnesses in children and adolescents, biofeedback has become a significant therapeutic technique in pediatric treatment. Numerous randomized controlled trials have shown that it works well under various circumstances. Biofeedback has been demonstrated to be an effective technique in pediatric dentistry for reducing dental anxiety. According to Padminee et al. (2022), using biofeedback relaxation and audio-visual distraction techniques when administering local anesthesia to children ages 7 to 12 not only decreased anxiety but also improved the experience 9 . In children receiving dental restorations, biofeedback therapy had a good impact on both behavioral and physiological responses, suggesting that it may enhance coping mechanisms during stressful dental operations 10 . Through the modulation of autonomic nervous system responses, heart rate variability (HRV) biofeedback has proven effective in managing chronic pain in children and adolescents 11 . Children with lower urinary tract dysfunction (LUTD) responded well to electromyographic (EMG) biofeedback because it improved bladder control, resulting in notable improvements in voiding patterns and fewer episodes of incontinence. In order to effectively manage LUTD, EMG biofeedback helps patients recognize and control pelvic floor muscle activity 13 . By measuring cerebral blood flow, hemoencephalographic (HEG) biofeedback is a neurofeedback approach that helps people self-regulate brain activity. This can assist children with Attention-Deficit/Hyperactivity Disorder (ADHD) improve their cognitive abilities and behavioral control. Regardless of the placebo-related teaching, HEG biofeedback was successful in enhancing behavioral outcomes, self-regulation, and attention in children with ADHD 14 . There is evidence that in pediatric neurorehabilitation, biofeedback improves both motor and cognitive abilities. Children with spastic hemiplegic cerebral palsy showed significant improvements in visual-motor integration, visual perception, and motor coordination when augmented biofeedback training was paired with physical therapy 12 . When compared to bilateral transcutaneous posterior tibial nerve stimulation, biofeedback therapy was more successful in improving bowel control and lowering symptoms of functional non-retentive fecal incontinence in children 15 . In young people with cerebral palsy, biofeedback and therapeutic training through video games significantly enhanced motor control. Real-time muscle feedback was given via the biofeedback, and increased engagement through the video game format improved motor performance and therapeutic adherence 16 . These studies show the potential of biofeedback as a complete pediatric care strategy for children and teenagers, emphasizing its versatility in responding to a wide range of disorders. Biofeedback empowers patients and improves the efficacy of medical interventions by allowing children and adolescents to actively participate in their treatment and control their physiological responses. This enhances outcomes across a range of therapeutic circumstances. Two umbrella reviews on the subject were found after MEDLINE, the Cochrane Database of Systematic Reviews, and JBI Evidence Synthesis databases were searched in an initial search. The effectiveness of biofeedback therapies in pediatric populations has gained attention due to the growing need for non-invasive, non-pharmacological treatments for a wide range of physical and psychological conditions in children and adolescents. Despite promising results, the evidence on biofeedback therapies across different conditions and populations remains scattered. Previous umbrella reviews, such as Markozannes et al. (2017) and Correll et al. (2021), have addressed biofeedback therapies, but they focused on narrow aspects of treatment, such as pain management and neurological disorders. Psychological therapies specifically aimed at pain management in children and adolescents, such as chronic pain disorders, recurring abdominal pain, and needle-related pain, were studied by Markozannes et al. (2017) 17 . The effectiveness, acceptability, and tolerance of pharmacological, psychosocial, and brain stimulation therapies for mental disorders are examined by Correll et al. (2021) 18 . Only research pertaining to children and adolescents is included. Pediatric and adolescent populations benefit greatly from biofeedback therapies because they help manage illnesses like migraines, ADHD, anxiety disorders, and problems with bladder or bowel control, as well as developmental hurdles (Suter, 1999) 28 . In order to keep younger people interested, biofeedback techniques are frequently modified using gamified or visually appealing approaches. Shorter sessions and caregiver participation are also used to improve adherence (Hammel et al., 2007) 29 . The emphasis is on imparting self-control abilities that have long-term advantages. Adult biofeedback, on the other hand, tends to be more goal-oriented, focusing on stress management, performance enhancement, and chronic health concerns. Its simple techniques are well-suited to break old patterns and increase intrinsic motivation (Yucha & Montgomery, 2008) 31 . According to Peper et al. (2010), adults usually take longer to learn biofeedback techniques but can obtain long-lasting health improvements, whereas children may adapt to them more rapidly but still need consistent instruction 30 . Overall, biofeedback is a versatile and effective therapeutic technique that focuses on controlling chronic diseases in adults while underlining developmental stages in children. This umbrella review is required to consolidate the rising database of literature on biofeedback therapy in children and adolescents. This review will cover a wide range of biofeedback applications in pediatric populations, including its efficacy in anxiety, ADHD, chronic pain, and neurodevelopmental disorders. Numerous systematic reviews on the efficacy of biofeedback for diseases like ADHD, cerebral palsy, anxiety, recurrent headaches, and muscular strengthening have been carried out in recent years among children and adolescents 19,20,21 . Our objective, in this review, is to evaluate the effectiveness of biofeedback therapies in paediatric populations across a range of disease conditions. Review question What is the effectiveness of biofeedback therapies in pediatric populations? Inclusion criteria Participants The review will be restricted to children and adolescent populations. Participants in the review are not limited to those who have any particular medical condition. To encourage consistency and comparability, established criteria or principles will be applied whenever possible. In the case of mixed populations, stratification (i.e., children and adolescents) will be undertaken where appropriate. Interventions This review will focus on looking at biofeedback therapy as a treatment modality for a variety of systemic illnesses. Biofeedback is a technique used to monitor and change physiological activity, that has been used clinically to address a myriad of both adult and pediatric diagnoses. In order to help patients make long-term generalizations of these physiological changes, biofeedback is a type of treatment where patients receive input on how to alter their physiological activity, such as their breathing, heart rate, muscle contractions, skin temperature, and brainwaves 2 . Comparators Studies that will have a control group, either a placebo or any alternative treatments will be considered. Outcomes The primary outcomes that will be considered for effectiveness of biofeedback therapies are “Improvements in attention and cognitive function” 21 , “Functional Mobility and Quality of Life improvement” 19 , “Behavioural improvements and emotional regulation” 20,21 . Any follow-up period outcomes will be included. Context There will be no restrictions on the review's scope, and it will incorporate systematic reviews of research conducted in general or public hospitals in addition to private clinics. In addition, there will be no geographical restrictions on context. Type of studies This research will take into account quantitative systematic reviews that evaluate the effectiveness of biofeedback therapy in the pediatric population, whether or not they include meta-analyses. Along with comparators, systematic reviews of pre-post intervention designs, quasi-experimental trials, randomized controlled trials, non-randomized controlled trials, and other experimental study designs will be included. Systematic reviews including mixed populations (adults and children/adolescents) will only be considered if a separate synthesis/meta-analysis is presented for children and adolescents. Reviews that are opinion-based, narrative, qualitative, or textual will not be accepted. A well-defined search strategy that incorporates several data sources and a consistent methodology are essential for the systematic review 22 . Systematic reviews must be critically appraised or risk of bias assessed before being included in this review. Methods The umbrella review has been prospectively filed in PROSPERO (CRD42024604976) and will be carried out in compliance with JBI methodology 23 . To ensure comprehensive reporting, the review will comply with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines 24 . Search strategy Three-step search method will be used to find both published and unpublished systematic reviews in order to gain a thorough understanding of the topic. To find pertinent publications, a limited search of MEDLINE (PubMed) will be conducted first. On the basis of the title, abstract, and index terms used to describe these articles, a thorough search strategy will be created for the final databases (Appendix I). Each database and information source covered in the study will have a customized search strategy that includes both index terms and keywords. Moreover, the citations of all the sources that are part of the study will be carefully examined to find any relevant additional research, focusing on the references of studies that have already been reviewed. Due to resource constraints, the review will only take into account English-language publications from the beginning to the present. Publications that are withdrawn will not be included. MEDLINE (Ovid), Scopus, CINAHL (Ovid), The Cochrane Database of Systematic Reviews, JBI Evidence Synthesis (Ovid), and Epistemonikos are among the electronic resources that will be searched. We will also search unpublished and gray literature sources including Google Scholar, OAIster, and ProQuest Dissertation and Thesis. The search will also include official papers or documents (from government websites), research reports from health agencies, The Evidence for Policy and Practice Information and Co-ordinating Center, and the Open Science Framework. The first search queries tested in MEDLINE were “biofeedback”, “biofeedback therapy,” “neurofeedback,” “myofeedback,” “pediatric,” [Filter: “systematic review” OR “Meta-Analysis”]. Individual databases will have their own unique keywords and index terms. Study selection Following the search, references will be gathered and added to Mendeley v.2.64 (Mendeley Ltd., Elsevier, Netherlands), making sure that duplicates are eliminated. 20 records will be used in a pilot study, and reviewers MV and DG will evaluate titles and abstracts separately in accordance with the inclusion criteria. Titles and abstracts will be checked by two independent reviewers for comparison with the review's inclusion criteria after a pilot test of 20 records. Full-text screening will be carried out using the JBI System for the Unified Management, Assessment, and Review of Information (JBI SUMARI; Adelaide, Australia) 25 . The complete text of chosen citations will be thoroughly evaluated by two independent reviewers (MV, DG) in accordance with the inclusion criteria. The umbrella review will include a list of excluded articles that don't fit the requirements. A third reviewer (RD) will be consulted if there are differences amongst the reviewers at any point during the selection process. The final report will include a PRISMA flow diagram and a thorough presentation of the search findings 24 . The umbrella review will cover both systematic reviews if the primary investigations from them overlap. The review will incorporate a citation matrix and compute the corrected coverage area index to guarantee an accurate representation of the overlap of main studies in the systematic reviews 26 . Assessment of methodological quality Two independent reviewers (MV, DG) will conduct a methodological quality check on a subset of individual systematic reviews and use the standardized JBI critical appraisal instrument for systematic reviews and research synthesis to critically evaluate a subset of syntheses 27 . We will not critically evaluate every primary study that is included in the chosen systematic reviews. A third reviewer (RD) or discussion will be used to settle any disagreements between the reviewers. All syntheses will undergo data extraction and synthesis, irrespective of their methodological quality. The critical appraisal's findings will be shown in a table and as a narrative. Data extraction A customized JBI data extraction tool will be used to extract data from systematic reviews that were included by two independent reviewers (MV and DG) following an initial pilot. The process of data extraction will encompass specific details regarding the type of review, such as the number of studies included and the critical appraisal checklist. It will also cover information about the population, including sample size, age, and gender, as well as the condition or health issue being addressed, the country and environment where the review took place, specifics of the treatment (like delivery method, frequency, and duration), the outcome presented as rates, and the method of analysis. Additionally, it will include meta-analysis particulars like effect measure, effect size, level of significance, and reported heterogeneity. In situations where further information is required, the authors will be contacted personally to obtain the data (2 emails will be sent in a 2-week period). In cases where the reviewers cannot agree, a third reviewer (RD) will be consulted. Data summary and synthesis To evaluate the efficacy of biofeedback interventions for children, the information extracted from the chosen reviews will be organized into tables and analysed through narrative synthesis. The collected information will also be condensed using the characteristics of the incorporated systematic reviews, including the count of studies undertaken for the finding, themethodological assessment, and the timeframe. Furthermore, the narrative synthesis will tackle the specific queries and goals of the review. Any duplication among studies will be recognized and displayed in a table. The particulars of the intervention will be delineated based on its category, participants, and level of assimilation. The outcomes will encompass the count of observed occurrences for each group (n), the number of participants randomly allocated to each group (N), the effect estimate (either odds ratio or relative risk), the confidence interval (CI), the precise P values, if available, and the titles of any statistical analysis that were conducted. The findings of the umbrella review will be summarized in a Summary of Findings. Assessing certainty in the findings The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, utilizing GRADEpro GDT (McMaster University, ON, Canada), will be used to assess the degree of certainty in the evidence 22 . The evaluation at the result level will be carried out by two independent reviewers (MV, DG). Any differences will be discussed and resolved by the reviewers or a third reviewer (RD). The Summary of Findings will contain pertinent data, such as absolute and relative risk estimates for the intervention and control groups, as well as a quality assessment of the available data. Potential bias in the review outcomes, as well as their directness, heterogeneity, precision, and risk of publication bias, will all be considered in the ranking. When selecting various reviews that present meta-analyses for the same outcome, the following criteria will be used: meta-analyses from reviews with lower heterogeneity ( I 2 ), more studies, and a reduced risk of bias will be preferred. Health attendance and non-attendance rates will be the main topics of the results that are shown in the Summary of Findings. References Ostojic K, Paget SP, Webb A, Khut GP, Morrow AM. Biofeedback assisted relaxation training and distraction therapy for pain in children undergoing botulinum neurotoxin A injections: A crossover randomized controlled trial. 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Peper E, Harvey R, Lin IM, Tylova H. Adapting biofeedback for children with learning disabilities or ADHD. Biofeedback. 2010;38(2):66–71. Yucha CB, Montgomery D, editors. Evidence-based practice in biofeedback and neurofeedback. Association for Applied Psychophysiology and Biofeedback; 2008. Additional Declarations The authors declare no competing interests. Supplementary Files AppendixI.docx Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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08:10:06","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":16936,"visible":true,"origin":"","legend":"","description":"","filename":"AppendixI.docx","url":"https://assets-eu.researchsquare.com/files/rs-8635013/v1/98524602e98ec603c5056850.docx"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003eEffectiveness of biofeedback therapies in pediatric populations: an umbrella review protocol\u003c/p\u003e","fulltext":[{"header":"Introduction","content":"\u003cp\u003eManaging chronic pain, anxiety disorders, attention-deficit/hyperactivity disorder (ADHD), and psychosomatic diseases in young patients during medical procedures presents a substantial challenge, necessitating the development of novel therapeutic techniques. Biofeedback-assisted relaxation training and virtual reality (VR)-based distraction therapy have emerged as potentially effective treatments for these and other illnesses. Ostojic et al. (2022) conducted a crossover randomized controlled experiment to investigate the efficacy of combining biofeedback-assisted relaxation training with distraction therapy on children undergoing botulinum neurotoxin treatment\u003csup\u003e1\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eIn addition to managing pain and anxiety, biofeedback has demonstrated potential in the treatment of other pediatric ailments. A thorough review of biofeedback's clinical uses, such as its use in treating functional gastrointestinal diseases such functional abdominal discomfort, speech and motor problems, and ADHD, is given by Malik and Dua (2023)\u003csup\u003e2\u003c/sup\u003e. Wider medical applications of biofeedback have been demonstrated, highlighting its adaptability in treating ailments like urine incontinence and visual-motor integration impairments in children with cerebral palsy\u003csup\u003e3\u003c/sup\u003e. In order to improve treatment outcomes for illnesses like anxiety and cleft lip and palate, biofeedback has recently been integrated with cutting-edge technology like virtual reality and game-based therapies\u003csup\u003e4,5,6,7,8\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eWith its non-invasive and adaptable approach to treating a range of physical and psychological illnesses in children and adolescents, biofeedback has become a significant therapeutic technique in pediatric treatment. Numerous randomized controlled trials have shown that it works well under various circumstances.\u003c/p\u003e \u003cp\u003eBiofeedback has been demonstrated to be an effective technique in pediatric dentistry for reducing dental anxiety. According to Padminee et al. (2022), using biofeedback relaxation and audio-visual distraction techniques when administering local anesthesia to children ages 7 to 12 not only decreased anxiety but also improved the experience\u003csup\u003e9\u003c/sup\u003e. In children receiving dental restorations, biofeedback therapy had a good impact on both behavioral and physiological responses, suggesting that it may enhance coping mechanisms during stressful dental operations\u003csup\u003e10\u003c/sup\u003e. Through the modulation of autonomic nervous system responses, heart rate variability (HRV) biofeedback has proven effective in managing chronic pain in children and adolescents\u003csup\u003e11\u003c/sup\u003e. Children with lower urinary tract dysfunction (LUTD) responded well to electromyographic (EMG) biofeedback because it improved bladder control, resulting in notable improvements in voiding patterns and fewer episodes of incontinence. In order to effectively manage LUTD, EMG biofeedback helps patients recognize and control pelvic floor muscle activity\u003csup\u003e13\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eBy measuring cerebral blood flow, hemoencephalographic (HEG) biofeedback is a neurofeedback approach that helps people self-regulate brain activity. This can assist children with Attention-Deficit/Hyperactivity Disorder (ADHD) improve their cognitive abilities and behavioral control. Regardless of the placebo-related teaching, HEG biofeedback was successful in enhancing behavioral outcomes, self-regulation, and attention in children with ADHD\u003csup\u003e14\u003c/sup\u003e. There is evidence that in pediatric neurorehabilitation, biofeedback improves both motor and cognitive abilities. Children with spastic hemiplegic cerebral palsy showed significant improvements in visual-motor integration, visual perception, and motor coordination when augmented biofeedback training was paired with physical therapy\u003csup\u003e12\u003c/sup\u003e. When compared to bilateral transcutaneous posterior tibial nerve stimulation, biofeedback therapy was more successful in improving bowel control and lowering symptoms of functional non-retentive fecal incontinence in children\u003csup\u003e15\u003c/sup\u003e. In young people with cerebral palsy, biofeedback and therapeutic training through video games significantly enhanced motor control. Real-time muscle feedback was given via the biofeedback, and increased engagement through the video game format improved motor performance and therapeutic adherence\u003csup\u003e16\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThese studies show the potential of biofeedback as a complete pediatric care strategy for children and teenagers, emphasizing its versatility in responding to a wide range of disorders. Biofeedback empowers patients and improves the efficacy of medical interventions by allowing children and adolescents to actively participate in their treatment and control their physiological responses. This enhances outcomes across a range of therapeutic circumstances.\u003c/p\u003e \u003cp\u003eTwo umbrella reviews on the subject were found after MEDLINE, the Cochrane Database of Systematic Reviews, and JBI Evidence Synthesis databases were searched in an initial search. The effectiveness of biofeedback therapies in pediatric populations has gained attention due to the growing need for non-invasive, non-pharmacological treatments for a wide range of physical and psychological conditions in children and adolescents. Despite promising results, the evidence on biofeedback therapies across different conditions and populations remains scattered. Previous umbrella reviews, such as Markozannes et al. (2017) and Correll et al. (2021), have addressed biofeedback therapies, but they focused on narrow aspects of treatment, such as pain management and neurological disorders. Psychological therapies specifically aimed at pain management in children and adolescents, such as chronic pain disorders, recurring abdominal pain, and needle-related pain, were studied by Markozannes et al. (2017)\u003csup\u003e17\u003c/sup\u003e. The effectiveness, acceptability, and tolerance of pharmacological, psychosocial, and brain stimulation therapies for mental disorders are examined by Correll et al. (2021)\u003csup\u003e18\u003c/sup\u003e. Only research pertaining to children and adolescents is included.\u003c/p\u003e \u003cp\u003ePediatric and adolescent populations benefit greatly from biofeedback therapies because they help manage illnesses like migraines, ADHD, anxiety disorders, and problems with bladder or bowel control, as well as developmental hurdles (Suter, 1999)\u003csup\u003e28\u003c/sup\u003e. In order to keep younger people interested, biofeedback techniques are frequently modified using gamified or visually appealing approaches. Shorter sessions and caregiver participation are also used to improve adherence (Hammel et al., 2007)\u003csup\u003e29\u003c/sup\u003e. The emphasis is on imparting self-control abilities that have long-term advantages. Adult biofeedback, on the other hand, tends to be more goal-oriented, focusing on stress management, performance enhancement, and chronic health concerns. Its simple techniques are well-suited to break old patterns and increase intrinsic motivation (Yucha \u0026amp; Montgomery, 2008)\u003csup\u003e31\u003c/sup\u003e. According to Peper et al. (2010), adults usually take longer to learn biofeedback techniques but can obtain long-lasting health improvements, whereas children may adapt to them more rapidly but still need consistent instruction\u003csup\u003e30\u003c/sup\u003e. Overall, biofeedback is a versatile and effective therapeutic technique that focuses on controlling chronic diseases in adults while underlining developmental stages in children.\u003c/p\u003e \u003cp\u003eThis umbrella review is required to consolidate the rising database of literature on biofeedback therapy in children and adolescents. This review will cover a wide range of biofeedback applications in pediatric populations, including its efficacy in anxiety, ADHD, chronic pain, and neurodevelopmental disorders. Numerous systematic reviews on the efficacy of biofeedback for diseases like ADHD, cerebral palsy, anxiety, recurrent headaches, and muscular strengthening have been carried out in recent years among children and adolescents\u003csup\u003e19,20,21\u003c/sup\u003e. Our objective, in this review, is to evaluate the effectiveness of biofeedback therapies in paediatric populations across a range of disease conditions.\u003c/p\u003e"},{"header":"Review question","content":"\u003cp\u003eWhat is the effectiveness of biofeedback therapies in pediatric populations?\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eInclusion criteria\u003c/h2\u003e \u003cdiv id=\"Sec4\" class=\"Section3\"\u003e \u003ch2\u003eParticipants\u003c/h2\u003e \u003cp\u003eThe review will be restricted to children and adolescent populations. Participants in the review are not limited to those who have any particular medical condition. To encourage consistency and comparability, established criteria or principles will be applied whenever possible. In the case of mixed populations, stratification (i.e., children and adolescents) will be undertaken where appropriate.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e\n\u003ch3\u003eInterventions\u003c/h3\u003e\n\u003cp\u003eThis review will focus on looking at biofeedback therapy as a treatment modality for a variety of systemic illnesses. Biofeedback is a technique used to monitor and change physiological activity, that has been used clinically to address a myriad of both adult and pediatric diagnoses. In order to help patients make long-term generalizations of these physiological changes, biofeedback is a type of treatment where patients receive input on how to alter their physiological activity, such as their breathing, heart rate, muscle contractions, skin temperature, and brainwaves\u003csup\u003e2\u003c/sup\u003e.\u003c/p\u003e\n\u003ch3\u003eComparators\u003c/h3\u003e\n\u003cp\u003eStudies that will have a control group, either a placebo or any alternative treatments will be considered.\u003c/p\u003e\n\u003ch3\u003eOutcomes\u003c/h3\u003e\n\u003cp\u003eThe primary outcomes that will be considered for effectiveness of biofeedback therapies are \u0026ldquo;Improvements in attention and cognitive function\u0026rdquo;\u003csup\u003e21\u003c/sup\u003e, \u0026ldquo;Functional Mobility and Quality of Life improvement\u0026rdquo;\u003csup\u003e19\u003c/sup\u003e, \u0026ldquo;Behavioural improvements and emotional regulation\u0026rdquo;\u003csup\u003e20,21\u003c/sup\u003e. Any follow-up period outcomes will be included.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eContext\u003c/h2\u003e \u003cp\u003eThere will be no restrictions on the review's scope, and it will incorporate systematic reviews of research conducted in general or public hospitals in addition to private clinics. In addition, there will be no geographical restrictions on context.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eType of studies\u003c/h3\u003e\n\u003cp\u003eThis research will take into account quantitative systematic reviews that evaluate the effectiveness of biofeedback therapy in the pediatric population, whether or not they include meta-analyses. Along with comparators, systematic reviews of pre-post intervention designs, quasi-experimental trials, randomized controlled trials, non-randomized controlled trials, and other experimental study designs will be included.\u003c/p\u003e \u003cp\u003eSystematic reviews including mixed populations (adults and children/adolescents) will only be considered if a separate synthesis/meta-analysis is presented for children and adolescents. Reviews that are opinion-based, narrative, qualitative, or textual will not be accepted. A well-defined search strategy that incorporates several data sources and a consistent methodology are essential for the systematic review\u003csup\u003e22\u003c/sup\u003e. Systematic reviews must be critically appraised or risk of bias assessed before being included in this review.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eThe umbrella review has been prospectively filed in PROSPERO (CRD42024604976) and will be carried out in compliance with JBI methodology\u003csup\u003e23\u003c/sup\u003e. To ensure comprehensive reporting, the review will comply with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines\u003csup\u003e24\u003c/sup\u003e.\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eSearch strategy\u003c/h2\u003e \u003cp\u003eThree-step search method will be used to find both published and unpublished systematic reviews in order to gain a thorough understanding of the topic. To find pertinent publications, a limited search of MEDLINE (PubMed) will be conducted first. On the basis of the title, abstract, and index terms used to describe these articles, a thorough search strategy will be created for the final databases (Appendix I).\u003c/p\u003e \u003cp\u003eEach database and information source covered in the study will have a customized search strategy that includes both index terms and keywords. Moreover, the citations of all the sources that are part of the study will be carefully examined to find any relevant additional research, focusing on the references of studies that have already been reviewed. Due to resource constraints, the review will only take into account English-language publications from the beginning to the present. Publications that are withdrawn will not be included.\u003c/p\u003e \u003cp\u003eMEDLINE (Ovid), Scopus, CINAHL (Ovid), The Cochrane Database of Systematic Reviews, JBI Evidence Synthesis (Ovid), and Epistemonikos are among the electronic resources that will be searched. We will also search unpublished and gray literature sources including Google Scholar, OAIster, and ProQuest Dissertation and Thesis. The search will also include official papers or documents (from government websites), research reports from health agencies, The Evidence for Policy and Practice Information and Co-ordinating Center, and the Open Science Framework.\u003c/p\u003e \u003cp\u003eThe first search queries tested in MEDLINE were \u0026ldquo;biofeedback\u0026rdquo;, \u0026ldquo;biofeedback therapy,\u0026rdquo; \u0026ldquo;neurofeedback,\u0026rdquo; \u0026ldquo;myofeedback,\u0026rdquo; \u0026ldquo;pediatric,\u0026rdquo; [Filter: \u0026ldquo;systematic review\u0026rdquo; OR \u0026ldquo;Meta-Analysis\u0026rdquo;]. Individual databases will have their own unique keywords and index terms.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eStudy selection\u003c/h2\u003e \u003cp\u003eFollowing the search, references will be gathered and added to Mendeley v.2.64 (Mendeley Ltd., Elsevier, Netherlands), making sure that duplicates are eliminated. 20 records will be used in a pilot study, and reviewers MV and DG will evaluate titles and abstracts separately in accordance with the inclusion criteria. Titles and abstracts will be checked by two independent reviewers for comparison with the review's inclusion criteria after a pilot test of 20 records. Full-text screening will be carried out using the JBI System for the Unified Management, Assessment, and Review of Information (JBI SUMARI; Adelaide, Australia)\u003csup\u003e25\u003c/sup\u003e. The complete text of chosen citations will be thoroughly evaluated by two independent reviewers (MV, DG) in accordance with the inclusion criteria. The umbrella review will include a list of excluded articles that don't fit the requirements. A third reviewer (RD) will be consulted if there are differences amongst the reviewers at any point during the selection process. The final report will include a PRISMA flow diagram and a thorough presentation of the search findings\u003csup\u003e24\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eThe umbrella review will cover both systematic reviews if the primary investigations from them overlap. The review will incorporate a citation matrix and compute the corrected coverage area index to guarantee an accurate representation of the overlap of main studies in the systematic reviews\u003csup\u003e26\u003c/sup\u003e.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eAssessment of methodological quality\u003c/h2\u003e \u003cp\u003eTwo independent reviewers (MV, DG) will conduct a methodological quality check on a subset of individual systematic reviews and use the standardized JBI critical appraisal instrument for systematic reviews and research synthesis to critically evaluate a subset of syntheses\u003csup\u003e27\u003c/sup\u003e. We will not critically evaluate every primary study that is included in the chosen systematic reviews. A third reviewer (RD) or discussion will be used to settle any disagreements between the reviewers. All syntheses will undergo data extraction and synthesis, irrespective of their methodological quality. The critical appraisal's findings will be shown in a table and as a narrative.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eData extraction\u003c/h2\u003e \u003cp\u003eA customized JBI data extraction tool will be used to extract data from systematic reviews that were included by two independent reviewers (MV and DG) following an initial pilot.\u003c/p\u003e \u003cp\u003eThe process of data extraction will encompass specific details regarding the type of review, such as the number of studies included and the critical appraisal checklist. It will also cover information about the population, including sample size, age, and gender, as well as the condition or health issue being addressed, the country and environment where the review took place, specifics of the treatment (like delivery method, frequency, and duration), the outcome presented as rates, and the method of analysis. Additionally, it will include meta-analysis particulars like effect measure, effect size, level of significance, and reported heterogeneity. In situations where further information is required, the authors will be contacted personally to obtain the data (2 emails will be sent in a 2-week period). In cases where the reviewers cannot agree, a third reviewer (RD) will be consulted.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eData summary and synthesis\u003c/h2\u003e \u003cp\u003eTo evaluate the efficacy of biofeedback interventions for children, the information extracted from the chosen reviews will be organized into tables and analysed through narrative synthesis. The collected information will also be condensed using the characteristics of the incorporated systematic reviews, including the count of studies undertaken for the finding, themethodological assessment, and the timeframe. Furthermore, the narrative synthesis will tackle the specific queries and goals of the review. Any duplication among studies will be recognized and displayed in a table. The particulars of the intervention will be delineated based on its category, participants, and level of assimilation. The outcomes will encompass the count of observed occurrences for each group (n), the number of participants randomly allocated to each group (N), the effect estimate (either odds ratio or relative risk), the confidence interval (CI), the precise P values, if available, and the titles of any statistical analysis that were conducted. The findings of the umbrella review will be summarized in a Summary of Findings.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eAssessing certainty in the findings\u003c/h2\u003e \u003cp\u003eThe Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, utilizing GRADEpro GDT (McMaster University, ON, Canada), will be used to assess the degree of certainty in the evidence\u003csup\u003e22\u003c/sup\u003e. The evaluation at the result level will be carried out by two independent reviewers (MV, DG). Any differences will be discussed and resolved by the reviewers or a third reviewer (RD).\u003c/p\u003e \u003cp\u003eThe Summary of Findings will contain pertinent data, such as absolute and relative risk estimates for the intervention and control groups, as well as a quality assessment of the available data. Potential bias in the review outcomes, as well as their directness, heterogeneity, precision, and risk of publication bias, will all be considered in the ranking. When selecting various reviews that present meta-analyses for the same outcome, the following criteria will be used: meta-analyses from reviews with lower heterogeneity (\u003cem\u003eI\u003c/em\u003e\u003csup\u003e\u003cem\u003e2\u003c/em\u003e\u003c/sup\u003e), more studies, and a reduced risk of bias will be preferred. Health attendance and non-attendance rates will be the main topics of the results that are shown in the Summary of Findings.\u003c/p\u003e \u003c/div\u003e"},{"header":"References ","content":"\u003col\u003e\n\u003cli\u003eOstojic K, Paget SP, Webb A, Khut GP, Morrow AM. Biofeedback assisted relaxation training and distraction therapy for pain in children undergoing botulinum neurotoxin A injections: A crossover randomized controlled trial. Dev Med Child Neurol. 2022; 64(12): 1507\u0026ndash;1516. https://doi.org/10.1111/dmcn.15303\u003c/li\u003e\n\u003cli\u003eMalik K, Dua A. Biofeedback. 2023 Mar 2. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan\u0026ndash;. PMID: 31971716.\u003c/li\u003e\n\u003cli\u003eFrank DL, Khorshid L, Kiffer JF, Moravec CS, McKee MG. Biofeedback in medicine: who, when, why and how? Ment Health Fam Med. 2010 Jun;7(2):85-91. PMID:22477926; PMCID: PMC2939454.\u003c/li\u003e\n\u003cli\u003eOrgil Z, Karthic A, Bell N, Williams SE, Ding L, Kashikar-Zuck S, King CD, Olbrecht VA. Dataset used to refine a treatment protocol of a biofeedback-based virtual reality intervention for pain and anxiety in children and adolescents undergoing surgery. Data Brief. 2023 Jun 21;49:109331. doi: 10.1016/j.dib.2023.109331. PMID:37456123; PMCID: PMC10338292.\u003c/li\u003e\n\u003cli\u003eOrgil Z, Johnson L, Karthic A, Williams SE, Ding L, Kashikar-Zuck S, King CD, Olbrecht VA. Feasibility and acceptability of perioperative application of biofeedback-based virtual reality versus active control for pain and anxiety in children and adolescents undergoing surgery: protocol for a pilot randomised controlled trial. BMJ Open. 2023 Jan 25;13(1):e071274. doi: 10.1136/bmjopen-2022-071274. PMID: 36697053; PMCID: PMC9884985.\u003c/li\u003e\n\u003cli\u003eThabrew H, Stasiak K, Kumar H, Naseem T, Frampton C, Merry S. A Cognitive Behavioral Therapy-, Biofeedback-, and Game-Based eHealth Intervention to Treat Anxiety in Children and Young People With Long-Term Physical Conditions (Starship Rescue): Co-design and Open Trial. JMIR Serious Games. 2021 Sep 24;9(3):e26084. doi: 10.2196/26084. PMID: 34559053; PMCID: PMC8501411.\u003c/li\u003e\n\u003cli\u003eCleland J, Crampin L, Campbell L, Dokovova M. Protocol for SonoSpeech Cleft Pilot: a mixed-methods pilot randomized control trial of ultrasound visual biofeedback versus standard intervention for children with cleft lip and palate. Pilot Feasibility Stud. 2022 Apr 27;8(1):93. doi: 10.1186/s40814-022-01051-x. PMID: 35477444; PMCID: PMC9043876.\u003c/li\u003e\n\u003cli\u003eOstojic K, Sharp N, Paget S, Khut G, Morrow A. BrightHearts: A pilot study of biofeedback assisted relaxation training for the management of chronic pain in children with cerebral palsy. Paediatr Neonatal Pain. 2021 Oct 15;4(1):34-43. doi:10.1002/pne2.12062. PMID: 35546913; PMCID: PMC8975200.\u003c/li\u003e\n\u003cli\u003ePadminee K, Hemalatha R, Shankar P, Senthil D, Jayakaran TG, Kabita S. Effectiveness of biofeedback relaxation and audio-visual distraction on dental anxiety among 7- to 12-year-old children while administering local anaesthesia: A randomized clinical trial. Int J Paediatr Dent. 2022 Jan;32(1):31-40. doi: 10.1111/ipd.12787. Epub 2021 May 7. PMID: 33735517.\u003c/li\u003e\n\u003cli\u003eDedeepya P, Nuvvula S, Kamatham R, Nirmala SV. Behavioural and physiological outcomes of biofeedback therapy on dental anxiety of children undergoing restorations: a randomised controlled trial. Eur Arch Paediatr Dent. 2014 Apr;15(2):97-103. doi: 10.1007/s40368-013-0070-3. Epub 2013 Aug 2. PMID: 23907736.\u003c/li\u003e\n\u003cli\u003eYetwin AK, Mahrer NE, Bell TS, Gold JI. Heart Rate Variability biofeedback therapy for children and adolescents with chronic pain: A pilot study. J Pediatr Nurs. 2022 Sep-Oct;66:151-159. doi: 10.1016/j.pedn.2022.06.008. Epub 2022 Jun 28. PMID: 35777250\u003c/li\u003e\n\u003cli\u003eAlwhaibi RM, Alsakhawi RS, ElKholi SM. Augmented Biofeedback Training with Physical Therapy Improves Visual-Motor Integration, Visual Perception, and Motor Coordination in Children with Spastic Hemiplegic Cerebral Palsy: A Randomised Control Trial. Phys Occup Ther Pediatr. 2020;40(2):134-151. doi: 10.1080/01942638.2019.1646375. Epub 2019 Jul 31. PMID: 31364896.\u003c/li\u003e\n\u003cli\u003eDos Reis JN, Mello MF, Cabral BH, Mello LF, Saiovici S, Rocha FET. EMG biofeedback or parasacral transcutaneous electrical nerve stimulation in children with lower urinary tract dysfunction: A prospective and randomized trial. Neurourol Urodyn. 2019 Aug;38(6):1588-1594. doi: 10.1002/nau.24009. Epub 2019 Apr 25. PMID: 31025397.\u003c/li\u003e\n\u003cli\u003eSkalski S. Impact of placebo-related instruction on HEG biofeedback outcomes in children with ADHD. Appl Neuropsychol Child. 2022 Jul-Sep;11(3):383-390. doi: 10.1080/21622965.2020.1861546. Epub 2020 Dec 21. PMID: 33349043.\u003c/li\u003e\n\u003cli\u003eAbdelrahman EM, Abdel Ghafar MA, Selim AO, Ali OI, Balbaa MA. Biofeedback versus bilateral transcutaneous posterior tibial nerve stimulation in the treatment of functional non-retentive fecal incontinence in children: A randomized controlled trial. J Pediatr Surg. 2021 Aug;56(8):1349-1355. doi: 10.1016/j.jpedsurg.2020.09.016. Epub 2020 Sep 30. PMID: 33092813.\u003c/li\u003e\n\u003cli\u003eMacIntosh A, Desailly E, Vignais N, Vigneron V, Biddiss E. A biofeedback-enhanced therapeutic exercise video game intervention for young people with cerebral palsy: A randomized single-case experimental design feasibility study. PLoS One. 2020 Jun 22;15(6):e0234767. doi: 10.1371/journal.pone.0234767. PMID: 32569284; PMCID: PMC7307764.\u003c/li\u003e\n\u003cli\u003eMarkozannes G, Aretouli E, Rintou E, Dragioti E, Damigos D, Ntzani E, Evangelou E, Tsilidis KK. An umbrella review of the literature on the effectiveness of psychological interventions for pain reduction. BMC Psychol. 2017 Aug 31;5(1):31 \u003c/li\u003e\n\u003cli\u003eCorrell, C.U., Cortese, S., Croatto, G., Monaco, F., Krinitski, D., Arrondo, G., Ostinelli, E., Zangani, C., Fornaro, M., Estrad\u0026eacute;, A., Fusar-Poli, P., Carvalho, A.F. and Solmi, M. (2021), Efficacy and acceptability of pharmacological, psychosocial, and brain stimulation interventions in children and adolescents with mental disorders: an umbrella review. World Psychiatry, 20: 244-275\u003c/li\u003e\n\u003cli\u003eMoreau, N. G., Bodkin, A., Bjornson, K., Hobbs, A., Soileau, M., \u0026amp; Lahasky, K. (2016). Effectiveness of rehabilitation interventions to improve gait speed in children with cerebral palsy: systematic review and meta-analysis. Physical Therapy, 96(12), 1938-1954\u003c/li\u003e\n\u003cli\u003eDormal V, Vermeulen N, Mejias S. Is heart rate variability biofeedback useful in children and adolescents? A systematic review. J Child Psychol Psychiatry. 2021 Dec;62(12):1379-1390\u003c/li\u003e\n\u003cli\u003eMoreno-Garc\u0026iacute;a I, Cano-Crespo A, Rivera F. Results of Neurofeedback in Treatment of Children with ADHD: A Systematic Review of Randomized Controlled Trials. Appl Psychophysiol Biofeedback. 2022 Sep;47(3):145-181.\u003c/li\u003e\n\u003cli\u003eEden J, Levit L, Berg A, Morton S. Finding what works in health care: standards for systematic reviews. National Academies Press; 2011.\u003c/li\u003e\n\u003cli\u003eAromataris E, Fernandez R, Godfrey C, Holly C, Khalil H, Tungpunkom P Chapter 10: Umbrella reviews. In: Aromataris E, Munn Z, editors. JBI Manual for Evidence Synthesis [internet]. JBI; 2020 [cited 2022 May 30]. Available from: https://synthesismanual.jbi.global.\u003c/li\u003e\n\u003cli\u003ePage MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71.\u003c/li\u003e\n\u003cli\u003eMunn Z, Aromataris E, Tufanaru C, Stern C, Porritt K, Farrow J, et al. The development of software to support multiple systematic review types: the Joanna Briggs Institute System for the Unified Management, Assessment and Review of Information (JBI SUMARI). Int J Evid Based Healthc 2019;17(1):36\u0026ndash;43.\u003c/li\u003e\n\u003cli\u003ePieper D, Antoine SL, Mathes T, Neugebauer EAM, Eikermann M. Systematic review finds overlapping reviews were not mentioned in every other overview. J Clin Epidemiol 2014;67(4):368\u0026ndash;375.\u003c/li\u003e\n\u003cli\u003eGuyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336(7650):924\u0026ndash;926.\u003c/li\u003e\n\u003cli\u003eSuter SE. Biofeedback: techniques and applications for children and adolescents. J Behav Med. 1999;22(5):505\u0026ndash;20.\u003c/li\u003e\n\u003cli\u003eHammel J, Kesselring G, Litt B, Spijker L. Efficacy of biofeedback for stress management and physiological regulation in children: A review. Appl Psychophysiol Biofeedback. 2007;32(1):79\u0026ndash;88.\u003c/li\u003e\n\u003cli\u003ePeper E, Harvey R, Lin IM, Tylova H. Adapting biofeedback for children with learning disabilities or ADHD. Biofeedback. 2010;38(2):66\u0026ndash;71.\u003c/li\u003e\n\u003cli\u003eYucha CB, Montgomery D, editors. Evidence-based practice in biofeedback and neurofeedback. Association for Applied Psychophysiology and Biofeedback; 2008.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"M S Ramaiah University of Applied Sciences","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"biofeedback, pediatrics, effectiveness, disorders","lastPublishedDoi":"10.21203/rs.3.rs-8635013/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8635013/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eObjective\u003c/h2\u003e \u003cp\u003eThe objective of this umbrella review is to assess the effectiveness of biofeedback therapies in children and adolescents.\u003c/p\u003e\u003ch2\u003eIntroduction:\u003c/h2\u003e \u003cp\u003eBiofeedback (BF) is a mind\u0026ndash;body therapy that has been shown to produce sustained pain reduction using integrated computerised instruments to provide patients with real-time physiological data. BF teaches patients relaxation skills, instructing them to modify certain behavioural responses (e.g. - slow breathing) to affect physiological changes (e.g. -heart rate) that lead to reduced pain.\u003c/p\u003e\u003ch2\u003eInclusion criteria:\u003c/h2\u003e \u003cp\u003eSystematic reviews, with or without meta-analysis, that examine the effectiveness of biofeedback therapies in children and adolescents will be considered. The review will not be limited to any single medical conditions. The review will be limited to children and adolescents without any physical or mental disability.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eJBI methods will be used to conduct a comprehensive review and to search evidence sources in MEDLINE (Ovid), Scopus, CINAHL, Cochrane Central, and JBI Evidence Synthesis. Grey and gray literature sources will also be searched, including ProQuest Dissertations and Theses, OAIster, and Google Scholar. The review will focus on works published in english between the creation of the database and the present. Two independent reviewers will assess titles, abstracts, and full texts, and data will be extracted using a custom form. The JBI critical appraisal checklist will be used for the systematic review and research synthesis. The reliability of the evidence regarding the effectiveness of biofeedback therapy will be examined using the GRADE approach\u003c/p\u003e","manuscriptTitle":"Effectiveness of biofeedback therapies in pediatric populations: an umbrella review protocol","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-01-20 07:42:23","doi":"10.21203/rs.3.rs-8635013/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"c0708249-f6f6-4df0-8f79-a6f09c96303c","owner":[],"postedDate":"January 20th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":61335458,"name":"Pediatrics"},{"id":61335459,"name":"Translational Medicine"}],"tags":[],"updatedAt":"2026-01-20T07:42:23+00:00","versionOfRecord":[],"versionCreatedAt":"2026-01-20 07:42:23","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8635013","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8635013","identity":"rs-8635013","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}