Department of Obstetrics and Gynecology, University of Arizona College of Medicine, and the Department of Epidemiology and Biostatistics, Mel and Enid Zuckerman College of Public Health, University of Arizona, Phoenix, Arizona.
Obstet Gynecol. 2021 Jun 1;137(6):1032-1040. doi: 10.1097/AOG.0000000000004316.
To assess the effect of a consumer-based mobile meditation application (app) on wellness in outpatient obstetric and gynecology patients during the coronavirus disease 2019 (COVID-19) pandemic.
We conducted a randomized controlled trial at a university outpatient clinic of obstetric and gynecology patients during the COVID-19 pandemic. Women were randomly assigned to the intervention group, who was prescribed a mobile meditation app for 30 days, or the control group, which received standard care. The primary outcome was self-reported perceived stress. Secondary outcomes included self-reported depression, anxiety, sleep disturbance, and satisfaction with the meditation app. A sample size of 80 participants (40 per group) was calculated to achieve 84% power to detect a 3-point difference in the primary outcome.
From April to May 2020, 101 women were randomized in the study-50 in the meditation app group and 51 in the control group. Analysis was by intention-to-treat. Most characteristics were similar between groups. Perceived stress was significantly less in the intervention group at days 14 and 30 (mean difference 4.27, 95% CI 1.30-7.24, P=.005, d=0.69 and mean difference 4.28, 95% CI 1.68-6.88, P=.002, d=0.69, respectively). Self-reported depression and anxiety were significantly less in the intervention group at days 14 and 30 (depression: P=.002 and P=.04; anxiety: P=.01, and P=.04, respectively). Sleep disturbance was significantly less in the intervention group at days 14 and 30 (P=.001 and P=.02, respectively). More than 80% of those in the intervention group reported high satisfaction with the meditation app, and 93% reported that mindfulness meditation improved their stress.
Outpatient obstetric and gynecology patients who used the prescribed consumer-based mobile meditation app during the COVID-19 pandemic had significant reductions in perceived stress, depression, anxiety, and sleep disturbance compared with standard care.
ClinicalTrials.gov, NCT04329533.
评估基于消费者的移动冥想应用程序（app）在 COVID-19 大流行期间对门诊妇产科患者健康的影响。
我们在 COVID-19 大流行期间的大学门诊妇产科患者中进行了一项随机对照试验。将女性随机分配到干预组，为其开处为期 30 天的移动冥想应用程序，或对照组，接受标准护理。主要结局是自我报告的感知压力。次要结局包括自我报告的抑郁、焦虑、睡眠障碍和对冥想应用程序的满意度。计算了 80 名参与者（每组 40 名）的样本量，以达到 84%的功效来检测主要结局的 3 点差异。
2020 年 4 月至 5 月，101 名女性参与了这项研究，其中 50 名在冥想应用程序组，51 名在对照组。分析采用意向治疗。两组的大多数特征相似。干预组在第 14 天和第 30 天的感知压力明显低于对照组（平均差异 4.27，95%CI 1.30-7.24，P=.005，d=0.69 和平均差异 4.28，95%CI 1.68-6.88，P=.002，d=0.69，分别）。干预组在第 14 天和第 30 天的自我报告抑郁和焦虑明显低于对照组（抑郁：P=.002 和 P=.04；焦虑：P=.01 和 P=.04，分别）。干预组在第 14 天和第 30 天的睡眠障碍明显低于对照组（P=.001 和 P=.02，分别）。干预组中超过 80%的人报告对冥想应用程序非常满意，93%的人报告正念冥想改善了他们的压力。
与标准护理相比，在 COVID-19 大流行期间使用处方消费者移动冥想应用程序的门诊妇产科患者的感知压力、抑郁、焦虑和睡眠障碍明显降低。
ClinicalTrials.gov，NCT04329533。
