Shidhaye Rahul, Bangal Vidyadhar, Bhargav Hemant, Tilekar Swanand, Thanage Chitra, Suradkar Rakhee, Game Kalpesh, Pulate Vandana, Tambe Sonali, Murhar Vaibhav, Kunkulol Rahul
Senior Research Scientist and Associate Professor of Psychiatry, Pravara Institute of Medical Sciences, Loni, Maharashtra, 413736, India.
Visiting Researcher, Department of Health, Ethics and Society, Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands.
Wellcome Open Res. 2022 Aug 4;7:109. doi: 10.12688/wellcomeopenres.17729.2. eCollection 2022.
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 -based intervention for maternal ental health and i munity (Yoga-M ) in a rural community in India. 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 group or the Enhanced Usual Care (EUC) group. Participants in the Yoga-M 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 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. 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 intervention. CTRI/2022/01/039701. Prospectively registered with the Clinical Trials Registry of India on 25 January 2022.
女性的心理健康在孕期会受到不利影响。孕期的压力和抑郁会对胎儿的出生体重和神经认知发育产生负面影响。当前由新冠疫情引发的危机进一步加剧了这种紧张局面。孕期进行瑜伽练习对缓解压力和抑郁有有益影响，初步证据表明基于瑜伽的干预措施可以提高免疫力。本研究旨在检验一种基于瑜伽的孕产妇心理健康和免疫干预措施（Yoga-M）在印度一个农村社区的可行性、可接受性和初步疗效。 该研究设计将是一项单盲个体随机平行组对照试验，分配比例为1:1。孕周在12 - 24周之间的成年孕妇将被随机分配到Yoga-M组或强化常规护理（EUC）组。Yoga-M组的参与者将参加为期12周的每周一次的团体瑜伽课程，并被鼓励在家中练习瑜伽。在EUC组，参与者将接受一次健康教育。将评估参与者的资格、招募情况、护理保留率和研究完成率，并评估实施Yoga-M的可行性以及参与者对该干预措施的可接受性。从基线起三个月时，感知压力量表（PSS）、欧洲五维度健康量表评分（EQ-5D-5L）、威斯康星上呼吸道症状严重程度量表（WURSS-21）的得分变化以及血清C反应蛋白将用于评估初步疗效。 该试验的关键成果将是一份结构化的干预手册以及关于该干预措施的可行性、可接受性和初步疗效的证据，为开展一项解释性随机对照试验以评估Yoga-M干预措施的疗效和成本效益奠定基础。 CTRI/2022/01/039701。于2022年1月25日在印度临床试验注册中心进行前瞻性注册。
