An Intervention With Dance and Yoga for Girls With Functional Abdominal Pain Disorders (Just in TIME): Protocol for a Randomized Controlled Trial

BACKGROUND: Functional abdominal pain disorders (FAPDs) affect many children worldwide, predominantly girls, and cause considerable long-term negative consequences for individuals and society. Evidence-based and cost-effective treatments are therefore strongly needed. Physical activity has shown promising effects in the practical management of FAPDs. Dance and yoga are both popular activities that have been shown to provide significant psychological and pain-related benefits with minimal risk. The activities complement each other, in that dance involves dynamic, rhythmic physical activity, while yoga enhances relaxation and focus. OBJECTIVE: This study aims to evaluate the effects of a dance and yoga intervention among girls aged 9 to 13 years with FAPDs. METHODS: The study is a prospective randomized controlled trial among girls aged 9 to 13 years with functional abdominal pain, irritable bowel syndrome, or both. The target sample size was 150 girls randomized into 2 arms: an intervention arm that receives dance and yoga sessions twice weekly for 8 months and a control arm that receives standard care. Outcomes will be measured at baseline and after 4, 8, 12, and 24 months, and long-term follow-up will be conducted 5 years from baseline. Questionnaires, interviews, and biomarker measures, such as cortisol in saliva and fecal microbiota, will be used. The primary outcome is the proportion of girls in each group with reduced pain, as measured by the faces pain scale-revised in a pain diary, immediately after the intervention. Secondary outcomes are gastrointestinal symptoms, general health, mental health, stress, and physical activity. The study also includes qualitative evaluations and health economic analyses. This study was approved by the Regional Ethical Review Board in Uppsala (No. 2016/082 1-2). RESULTS: Data collection began in October 2016. The intervention has been performed in 3 periods from 2016 through 2019. The final 5-year follow-up is anticipated to be completed by fall 2023. CONCLUSIONS: Cost-effective and easily accessible interventions are warranted to reduce the negative consequences arising from FAPDs in young girls. Physical activity is an effective strategy, but intervention studies are needed to better understand what types of activities facilitate regular participation in this target group. The Just in TIME (Try, Identify, Move, and Enjoy) study will provide insights regarding the effectiveness of dance and yoga and is anticipated to contribute to the challenging work of reducing the burden of FAPDs for young girls. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02920268); https://clinicaltrials.gov/ct2/show/NCT02920268 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/19748