Mindfulness Effects in Obstetric and Gynecology Patients During the Coronavirus Disease 2019 (COVID-19) Pandemic: A Randomized Controlled Trial

Abstract

Objective: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Clinical trial registration: ClinicalTrials.gov, NCT04329533.

Conflict of interest statement

Financial Disclosure: Dr. Mourad reports conflict unrelated to this work with Applied Medical and Intuitive Surgical as a consultant. Dr. Huberty reports conflict related to this work as a consultant for Calm, Inc in the role of Director of Science and Director of Scientific Advisory Board. Dr. Huberty conducts investigator-initiated research that utilizes the Calm application, however, Calm, Inc does not financially support her research. Dr. Huberty is paid for her consultation on an as-needed basis, however, her role is to ensure the quality of Calm's science and she has no specific obligations to the company. Dr. Huberty receives no financial incentives (eg, stocks) related to the growth or success of the company. The other authors did not report any potential conflicts of interest.

Copyright © 2021 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.

Figures

Fig. 1.. CONSORT (Consolidated Standards of Reporting Trials) flowchart of patient recruitment and participation.

Smith. Mindfulness Effects During COVID-19. Obstet Gynecol 2021.

Fig. 2.. Effect of meditation application on perceived stress mean scores at three specified study time periods.

Smith. Mindfulness Effects During COVID-19. Obstet Gynecol 2021.