Yoga to improve maternal mental health and immune function during the COVID-19 crisis (Yoga-M2 trial): study protocol for a pilot randomized controlled trial. [version 2; peer review: 2 approved]

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 a Yoga -based intervention for maternal Mental health and iMmunity (Yoga-M 2) 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-M 2 group or the Enhanced Usual Care (EUC) group. Participants in the Yoga-M 2 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-M 2 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-M 2 intervention. Trial registration: CTRI/2022/01/039701. Prospectively registered with the Clinical Trials Registry of India on 25 January 2022.