Meditation and yoga for irritable bowel syndrome: study protocol for a randomised clinical trial (MY-IBS study).

ABSTRACT

INTRODUCTION: When delivered in person, yoga has been shown to be effective in managing irritable bowel syndrome (IBS) symptoms. Research is needed to test the feasibility and effectiveness of yoga as a therapeutic option when delivered virtually. The primary aim of the mind and yoga for IBS randomised controlled trial is to determine the effects of an 8-week virtual meditation and yoga intervention on IBS symptom severity compared with an advice-only active control group. METHODS AND ANALYSIS: Adults diagnosed with IBS will be randomised to receive either a Upa Yoga intervention or an advice-only control group. The intervention will consist of weekly online classes for 8 weeks delivered by a facilitator using Microsoft Office Teams and daily home practice. Feasibility will be evaluated by examining recruitment and attrition rates, adherence, participant satisfaction with the programme and safety. The primary outcome is IBS symptom severity, and key secondary outcomes include (but not limited to) quality of life, anxiety and depression symptoms, COVID-19-related stress and anxiety, and fatigue. Outcomes will be assessed at baseline, 4 weeks and 8 weeks. An embedded design experimental model substudy will be conducted post intervention using qualitative research methods to identify participants' experiences in the yoga programme. ETHICS AND DISSEMINATION This study has been approved by the Conjoint Health Research Ethics Board (REB ID 20-0084). Findings will be disseminated through peer-reviewed publication, conference presentation and social media. TRIAL REGISTRATION NUMBER NCT04302623.