Yoga to improve maternal mental health and immune function during the COVID-19 crisis (Yoga-M 2 trial): study protocol for a pilot randomized controlled trial.

Wellcome Open Research

article

Chitra Thanage¹  Rakhee Suradkar²  Kalpesh Game³  Vandana Pulate⁴  Sonali Tambe⁴  Vaibhav Murhar⁵  Rahul Kunkulol⁶  Rahul Shidhaye⁷  Vidyadhar Bangal⁹  Hemant Bhargav^1,10  Swanand Tilekar^1,11 

[1] Project Coordinator, Directorate of Research, Pravara Institute of Medical Sciences;Yoga Instructor, Directorate of Research, Pravara Institute of Medical Sciences;Clinical Research Coordinator, Directorate of Research, Pravara Institute of Medical Sciences;Tutor, Department of Pharmacology, Pravara Institute of Medical Sciences;Independent Researcher, Independent Researcher;Department of Pharmacology, Pravara Institute of Medical Sciences;Senior Research Scientist and Associate Professor of Psychiatry, Pravara Institute of Medical Sciences;Visiting Researcher, Department of Health, Ethics and Society, Care and Public Health Research Institute, Maastricht University;Department of Obstetrics and Gynecology, Pravara Institute of Medical Sciences;Department of Integrative Medicine, National Institute of Mental Health & Neurosciences;School of Public Health and Social Medicine, Pravara Institute of Medical Sciences

关键词: Yoga;    Pregnancy;    Stress;    Immunity;    India;   

DOI  :  10.12688/wellcomeopenres.17729.2

学科分类：内科医学

来源: Wellcome

【 摘 要 】

Background: Mental health of women is adversely affected during pregnancy. Stress and depression during pregnancy negatively impact birthweight and neuro-cognitive development of the fetus. The current crisis due to the COVID-19 pandemic further adds to the stressful situation. Yoga practiced during pregnancy has beneficial effects on improving stress and depression and preliminary evidence suggests that yoga-based interventions can improve immunity. This study aims to examine the feasibility, acceptability, and preliminary efficacy of aYoga-based intervention for maternalMental health and iMmunity (Yoga-M2) in a rural community in India.    Methods: The study design will be a single-blind individual randomized parallel group-controlled pilot trial with 1:1 allocation ratio. Adult pregnant women, with gestational age between 12–24 weeks will be randomly allocated to either the Yoga-M2 group or the Enhanced Usual Care (EUC) group. Participants in the Yoga-M2 arm will attend weekly group yoga sessions for 12 weeks and will be encouraged to practice yoga at home. In the EUC arm, participants will receive a single session of health education. Eligibility of the participants, recruitment, retention-in-care, and study completion rates will be estimated and feasibility of delivering Yoga-M2 and acceptability of this intervention by the participants will be assessed. Change in the scores of the Perceived Stress Scale (PSS), EuroQoL 5 Dimensions Score (EQ-5D-5L), Wisconsin Upper Respiratory Symptom Severity Scale (WURSS-21), and serum C-Reactive Protein at three-months from baseline will be used to assess preliminary efficacy.Discussion: The key outputs of this trial will be a structured intervention manual and evidence about the feasibility, acceptability, and preliminary efficacy of the intervention, establishing the foundation to undertake an explanatory randomized controlled trial to assess efficacy and cost-effectiveness of Yoga-M2 intervention. Trial registration: CTRI/2022/01/039701. Prospectively registered with the Clinical Trials Registry of India on 25 January 2022.

【 授权许可】

CC BY