Dataset used to refine a treatment protocol of a biofeedback-based virtual reality intervention for pain and anxiety in children and adolescents undergoing surgery.

There is a great need for nonpharmacologic pain management strategies, given the catastrophic effects of the opioid epidemic and the role of opioid prescription in precipitating addiction [1], particularly in children and adolescents at risk of chronic pain and opioid use after surgery [2], [3], [4]. Biofeedback-based virtual reality (VR-BF) is an innovative approach to managing pain that compliments and may even increase accessibility [5] and acceptability [6] of existing mind-body therapies for pain management, like biofeedback (BF). BF teaches patients behavioral modification techniques that impact involuntary processes [7,8]. For example, slow breathing increases heart rate variability (HRV) [9] to reduce pain through the downregulation of the sympathetic nervous system [10,11]. However, barriers to widespread use, such as the need for trained personnel and high costs of direct intervention, have hindered its widespread clinical use and access to this therapy [5,12]. VR-BF has not yet been integrated into perioperative care, and as such, no defined treatment protocols for preoperative training and postoperative application of VR-BF exist, particularly in children. The dataset presented in this article may help fill the unmet, critical need for accessible, effective, alternative therapeutic options for reducing postoperative pain and opioid exposure in children. This investigation aimed to establish measurable outcomes impacting a perioperative treatment protocol of VR-BF, a novel VR-based therapy that teaches patients relaxation techniques and monitors the sensitivity of heart rate variability (HRV) to different frequencies and durations of VR-BF sessions. Achievement of target physiological parameters, including HRV, was measured in children and adolescents undergoing surgery anticipated to cause moderate to severe pain (e.g., orthopedic, chest) requiring postoperative pain management by the Acute Pain Services at Nationwide Children's Hospital (NCH). This dataset included 23 surgical patients evaluated quantitatively and qualitatively to refine a treatment protocol for the feasibility and acceptability of (a) preoperative education and training in relaxation, and (b) postoperative application of a VR-BF intervention for pain management [13]. Qualitative data was collected using an investigator-derived questionnaire to obtain feedback and understand the patient and family experience using VR-BF. Descriptive statistics (mean±SD or median with interquartile range [IQR] for continuous variables; frequencies and percentages for categorical variables) and exploratory spline regression analyses were generated to define measurable outcomes for a future pilot, randomized clinical trial protocol.

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.

INTRODUCTION: Current clinical applications of virtual reality (VR) provide patients with transient pain relief during acutely painful events by redirecting attention. Biofeedback (BF) is a mind-body therapy that effectively produces sustained pain reduction, but there are obstacles to its routine use. Combined, BF-based VR (VR-BF) may increase accessibility while enhancing the benefits of BF. VR-BF has yet to be employed in perioperative care, and as such, no defined treatment protocol for VR-BF exists. The primary aim of this study is to assess the feasibility of the perioperative use of VR-BF in children and adolescents. The secondary aims are to assess the acceptability of VR-BF and to collect pilot efficacy data. METHODS AND ANALYSIS: This is a single-centre, randomised controlled pilot clinical trial. A total of 70 patients (12-18 years) scheduled for surgery anticipated to cause moderate to severe pain with ≥1 night of hospital admission will be randomised to one of two study arms (VR-BF or control). Participants randomised to VR-BF (n=35) will use the ForeVR VR platform to engage their breathing in gamified VR applications. Participants randomised to control (n=35) will interact with a pain reflection app, Manage My Pain. The primary outcome is feasibility of VR-BF use in adolescents undergoing surgery as assessed through recruitment, enrolment, retention and adherence to the protocol. Secondary outcomes are acceptability of VR-BF and pilot efficacy measures, including pain, anxiety and opioid consumption. ETHICS AND DISSEMINATION: The protocol was approved by the Nationwide Children's Hospital Institutional Review Board (IRB #STUDY00002080). Patient recruitment begins in March 2023. Written informed consent is obtained for all participants. All information acquired will be disseminated via scientific meetings and published in peer-reviewed journals. Data will be available per request and results will be posted on ClinicalTrials.gov. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04943874).

A qualitative study of risk and resilience in young adult women with a history of juvenile-onset fibromyalgia.

BACKGROUND: Juvenile-onset Fibromyalgia (JFM) is a chronic pain condition characterized by widespread musculoskeletal pain, fatigue, sleep difficulties, mood concerns, and other associated symptoms. Although diagnosed in childhood, JFM often persists into adulthood can result in continued physical, social, and psychological impairment. The purpose of this qualitative study was to identify themes of risk and resilience for long-term outcomes among young adults diagnosed with JFM in childhood. METHODS: The sample included 13 young adults (ages 26-34) who had been diagnosed with JFM in adolescence. Focus groups were used to elicit qualitative information about living with JFM and perceived challenges and buffering factors impacting their adjustment. RESULTS: The majority of participants (80%, N = 12) continued to meet criteria for fibromyalgia (FM). An iterative, thematic analysis revealed themes of resilience (e.g., greater acceptance, re-setting expectations, active coping, addressing mental health) and risk (e.g., lack of information, stigma, isolation, negative healthcare experiences). CONCLUSION: Results suggest the need for longer follow-up of youth with JFM as they transition to adulthood with multidisciplinary care and more attention to education about JFM and associated symptoms such as fatigue, as well as ongoing support for coping and mental health needs. A holistic approach to care during the transition years could be beneficial to minimize impact of JFM on long-term functioning.

Randomized clinical trial of Fibromyalgia Integrative Training (FIT teens) for adolescents with juvenile fibromyalgia - Study design and protocol.

OBJECTIVE: Juvenile-onset fibromyalgia (JFM) is a chronic debilitating pain condition that negatively impacts physical, social and academic functioning. Cognitive-behavioral therapy (CBT) is beneficial in reducing functional disability among adolescents with JFM but has only a modest impact on pain reduction and does not improve physical exercise participation. This randomized controlled trial (RCT) aims to test whether a novel intervention that combines CBT with specialized neuromuscular exercise training (the Fibromyalgia Integrative Training program for Teens "FIT Teens") is superior to CBT alone or a graded aerobic exercise (GAE) program. DESIGN/METHODS: This 3-arm multi-site RCT will examine the efficacy of the FIT Teens intervention in reducing functional disability (primary outcome) and pain intensity (secondary outcome), relative to CBT or GAE. All interventions are 8-weeks (16 sessions) in duration and are delivered in small groups of 4-6 adolescents with JFM. A total of 420 participants are anticipated to be enrolled across seven sites with approximately equal allocation to each treatment arm. Functional disability and average pain intensity in the past week will be assessed at baseline, post-treatment and at 3-, 6-, 9- and 12-month follow-up. The 3-month follow-up is the primary endpoint to evaluate treatment efficacy; longitudinal assessments will determine maintenance of treatment gains. Changes in coping, fear of movement, biomechanical changes and physical fitness will also be evaluated. CONCLUSIONS: This multi-site RCT is designed to evaluate whether the combined FIT Teens intervention will have significantly greater effects on disability and pain reduction than CBT or GAE alone for youth with JFM. Clinical trials.gov registration: NCT03268421.

Brain mechanisms impacted by psychological therapies for pain: identifying targets for optimization of treatment effects.

Psychological therapies, such as cognitive behavioral therapy, are widely used multifaceted approaches that have been shown to improve pain-related functioning. A small but growing number of studies have used brain imaging to support the use of psychological therapies for pain. Although these studies have led to an increased understanding of how therapies may engage neural systems, there are multiple technical and conceptual challenges to consider. Based on the current literature, several components of effective psychological therapies for pain may be supported by changes in neural circuitry, which are most consistently represented by diminished activation and/or reduced hyperconnectivity in brain regions related to pain processing, emotion, and cognitive control. Findings may vary based on methodological approaches used and may also differ depending on targets of treatment. To provide a nuanced understanding of the current literature, specific targets and components of effective treatments for which a neural basis has been investigated are reviewed. These treatment components include catastrophic thinking about pain, increasing self-efficacy, mindfulness, anxiety symptom reduction, and exposure-based approaches. In general, such strategies have the potential to normalize regional hyperactivations and reduce hyperconnectivity in brain regions associated with nociceptive processing, cognition, and emotion, although additional research is needed. By determining if there are indeed distinct brain mechanisms engaged by different components of psychological therapy and evidence for specific changes in neural function after these interventions, future therapies may be more optimally tailored for individuals afflicted with chronic pain.

Mindfulness-Based Stress Reduction for Adolescents with Functional Somatic Syndromes: A Pilot Cohort Study.

OBJECTIVE: To assess the feasibility of a mindfulness-based stress reduction (MBSR) program for adolescents with widespread chronic pain and other functional somatic symptoms and to make preliminary assessments of its clinical utility. STUDY DESIGN: Three cohorts of subjects completed an 8-week MBSR program. Child- and parent-completed measures were collected at baseline and 8 and 12 weeks later. Measures included the Functional Disability Inventory (FDI), the Fibromyalgia/Symptom Impact Questionnaire-Revised (FIQR/SIQR), the Pediatric Quality of Life Inventory, the Multidimensional Anxiety Scale (MASC2), and the Perceived Stress Scale. Subjects and parents were interviewed following the program to assess feasibility. RESULTS: Fifteen of 18 subjects (83%) completed the 8-week program. No adverse events occurred. Compared with baseline scores, significant changes were found in mean scores on the FDI (33% improvement, P = .026), FIQR/SIQR (26% improvement, P = .03), and MASC2 (child: 12% improvement, P = .02; parent report: 17% improvement, P = .03) at 8 weeks. MASC2 scores (child and parent) and Perceived Stress Scale scores were significantly improved at 12 weeks. More time spent doing home practice was associated with better outcomes in the FDI and FIQR/SIQR (44% and 26% improvement, respectively). Qualitative interviews indicated that subjects and parents reported social support as a benefit of the MBSR class, as well as a positive impact of MBSR on activities of daily living, and on pain and anxiety. CONCLUSIONS: MBSR is a feasible and acceptable intervention in adolescents with functional somatic syndromes and has preliminary evidence for improving functional disability, symptom impact, and anxiety, with consistency between parent and child measures. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02190474.

Preliminary Outcomes of a Cross-Site Cognitive-Behavioral and Neuromuscular Integrative Training Intervention for Juvenile Fibromyalgia.

OBJECTIVE: Cognitive-behavioral therapy (CBT) is effective in reducing disability among youth with juvenile fibromyalgia (FM); however, engagement in moderate to vigorous physical activity remains poor, even after CBT. The purpose of this study was to evaluate the feasibility and preliminary outcomes of an innovative program combining CBT with specialized neuromuscular exercise: the Fibromyalgia Integrative Training for Teens (FIT Teens) program. METHODS: Adolescents with juvenile FM (n = 22, all female, ages 12-18 years) from 2 urban children's hospitals participated in the 8-week FIT Teens intervention. Participants completed measures of pain intensity, functional disability, depressive symptoms, pain catastrophizing, fear of movement, and readiness to change at baseline and after the intervention. RESULTS: The feasibility of the intervention across 2 sites was documented, including high retention rates (80%). Participants showed significant decreases in functional disability (P < 0.05), depression (P < 0.001), fear of movement (P < 0.01), and pain catastrophizing (P < 0.001) from pre- to postintervention. Results of the readiness to change measure indicated a significant decrease in precontemplation (P < 0.01) and increase in action/maintenance scores (P < 0.001). All results demonstrated medium to large effect sizes. CONCLUSION: Adolescents with juvenile FM reported significant improvements in physical function and reduced fear of movement following the intervention. Improvement in physical function was achieved in a shorter time frame than in a prior trial of CBT without an exercise component. Further work is needed to compare the FIT Teens program with existing approaches and determine whether objective changes in exercise participation are achieved.

A survey of conventional and complementary therapies used by youth with juvenile-onset fibromyalgia.

Little is known regarding treatment choices of youth diagnosed with juvenile-onset fibromyalgia (JFM) as they move into young adulthood. Additionally, there is little empirical evidence to guide youth with FM into appropriate treatment options, leading to a variety of therapies used to manage FM symptoms. The purpose of this descriptive study was to examine all therapies used by individuals with JFM as they entered young adulthood and the perceived effectiveness of these treatments. As part of a larger follow-up study, participants completed a web-based survey of all current and past treatments received for FM symptoms 2 years after their initial presentation and diagnosis at a pediatric rheumatology clinic. One hundred ten out of 118 eligible patients participated in the follow-up assessment as young adults (mean age 18.97 years; 93.6% female). A majority of participants reported use of conventional medications (e.g., antidepressants, anticonvulsants) and nondrug therapies (e.g., psychotherapy). Currently and within the past 2 years, antidepressant medications were the most commonly used to manage FM. Complementary treatments were used less often, with massage being the most popular choice. Although currently used treatments were reported as being effective, past treatments, especially medications, were viewed as being more variably effective. This is a potential reason why young adults with JFM might try more complementary and alternative approaches to managing their symptoms. More controlled studies are needed to investigate the effectiveness of these complementary methods to assist treatment providers in giving evidence-based treatment recommendations.

Nonpharmacological treatment of pain in rheumatic diseases and other musculoskeletal pain conditions.

Pain is a complex phenomenon affected by biological, psychological, and social factors. Treatment of pain is most effective when using a multidisciplinary approach consisting of a careful selection of pharmacological and non-pharmacological interventions based upon disease factors, pain characteristics, psychological coping abilities, and lifestyle factors. In this review we focus on research-based evidence for non-pharmacological intervention including psychological intervention, physical exercise, patient education, and complementary approaches for pain management for patients with rheumatic diseases and common musculoskeletal pain conditions, such as low back pain. The vast majority of research studies on chronic pain conditions are focused on adults but pediatric studies are also reviewed wherever possible, to give the reader a more inclusive view of non-pharmacological approaches for pain management across the lifespan.