RESUMEN
Introduction: Women are vulnerable during pregnancy as they experience multiple physical and psychological problems which can lead to stress and poor quality of life ultimately affecting the development of the fetus and their health during and after pregnancy. Prior evidence suggests that prenatal yoga can improve maternal health and well-being and can have a beneficial effect on immune system functioning. To date, no study has been conducted in a rural, low-resource setting in India to assess the feasibility, acceptability, and preliminary efficacy of a yoga-based intervention on perceived stress, quality of life, pro-inflammatory biomarkers, and symptoms of upper respiratory tract infections. Methods: To address this gap and assess whether a yoga-based intervention could improve maternal mental health and immunity during the COVID-19 crisis (Yoga-M2 trial), a single-blind individual randomized parallel group-controlled pilot trial with a 1:1 allocation ratio was implemented. We randomly allocated 51 adult pregnant women, with gestational age between 12-24 weeks in the Yoga-M2 arm (n = 25) or the enhanced usual care arm (EUC) (n = 26). Feasibility and acceptability were assessed using the process data and In-Depth Interviews (IDIs) with the trial participants and yoga instructors. Multiple linear regression was used to compare follow-up scores for quantitative outcomes. Results: A three-month follow-up assessment was completed for 48 out of 51 participants (94.12%). We did not find any statistically significant difference between both arms in total Perceived Stress Scale scores, quality of life (Eq-5D-5L index), and serum C Reactive Protein levels at the three-month follow-up assessment. The critical barriers to practicing yoga were lack of knowledge about the benefits of yoga, lack of 'felt need' to practice yoga, lack of time to practice, lack of space, lack of transport, and lack of peer group to practice yoga. Despite this, women who regularly practiced yoga described the benefits and factors which motivated them to practice regularly. Discussion: The learnings from this trial will help design the explanatory trial in the future and the study findings can also be used by the primary health care system to deliver yoga-based interventions in the newly created health and wellness centers. Trial registration: This trial was prospectively registered with the Clinical Trials Registry of India on 25 January 2022. https://www.ctri.nic.in/Clinicaltrials/showallp.php?mid1=65173&EncHid=&userName=CTRI/2022/01/039701. Trial registration number: CTRI/2022/01/039701.
RESUMEN
Background: Mental health of women is adversely affected during pregnancy. A huge proportion of pregnant women suffer from stress and depression which negatively impacts 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 i Mmunity (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 post-randomization 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.