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冥想和瑜伽治疗肠易激综合征的随机临床试验研究方案(MY-IBS 研究)。

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

机构信息

Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada.

Faculty of Health Disciplines, Athabasca University, Athabasca, Alberta, Canada.

出版信息

BMJ Open. 2022 May 26;12(5):e059604. doi: 10.1136/bmjopen-2021-059604.

DOI:10.1136/bmjopen-2021-059604
PMID:35618329
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9137346/
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.

摘要

简介

当瑜伽以面对面的方式进行时,已经被证明对管理肠易激综合征(IBS)症状有效。当瑜伽以虚拟的方式进行时,需要研究来检验其作为一种治疗选择的可行性和有效性。该研究旨在确定 8 周的虚拟冥想和瑜伽干预对 IBS 症状严重程度的影响,与仅提供建议的积极对照组相比。

方法和分析

被诊断患有 IBS 的成年人将被随机分配接受 Upa Yoga 干预或仅提供建议的对照组。干预将包括每周一次的在线课程,持续 8 周,由一名导师使用 Microsoft Office Teams 进行授课,以及每天在家进行练习。通过检查招募和流失率、依从性、参与者对该计划的满意度和安全性,来评估可行性。主要结果是 IBS 症状严重程度,关键次要结果包括(但不限于)生活质量、焦虑和抑郁症状、与 COVID-19 相关的压力和焦虑以及疲劳。将在基线、4 周和 8 周时评估结果。干预后将使用定性研究方法进行嵌入式设计实验模型子研究,以确定参与者在瑜伽计划中的体验。

伦理和传播

这项研究已经得到卡尔加里大学 Conjoint 健康伦理审查委员会的批准(REB ID 20-0084)。研究结果将通过同行评审的出版物、会议演讲和社交媒体进行传播。

试验注册号

NCT04302623。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54b0/9137346/d940aef7d008/bmjopen-2021-059604f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54b0/9137346/d940aef7d008/bmjopen-2021-059604f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54b0/9137346/d940aef7d008/bmjopen-2021-059604f01.jpg

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