Mindfulness Effects in Obstetric and Gynecology Patients During the Coronavirus Disease 2019 (COVID-19) Pandemic: A Randomized Controlled Trial.
Study Goal
The researchers aimed to assess the effect of a consumer-based mobile meditation app on wellness, specifically perceived stress, depression, anxiety, and sleep disturbance, in outpatient obstetric and gynecology patients during the COVID-19 pandemic.
Results Summary
The study found that using the meditation app significantly reduced perceived stress, depression, anxiety, and sleep disturbance at days 14 and 30 compared to standard care, with high user satisfaction reported.
Population
Outpatient obstetric and gynecology patients during the COVID-19 pandemic.
Effective Dosage
Not specified (prescribed mobile meditation app for 30 days).
Duration
30 days
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
consumer-based mobile meditation application (app) | decrease | perceived stress | outpatient obstetric and gynecology patients during the COVID-19 pandemic | mean difference 4.27, 95% CI 1.30-7.24, P=.005, d=0.69 at day 14 | was significantly less | #1 |
consumer-based mobile meditation application (app) | decrease | perceived stress | outpatient obstetric and gynecology patients during the COVID-19 pandemic | mean difference 4.28, 95% CI 1.68-6.88, P=.002, d=0.69 at day 30 | was significantly less | #2 |
consumer-based mobile meditation application (app) | decrease | self-reported depression | outpatient obstetric and gynecology patients during the COVID-19 pandemic | P=.002 at day 14 | were significantly less | #3 |
consumer-based mobile meditation application (app) | decrease | self-reported depression | outpatient obstetric and gynecology patients during the COVID-19 pandemic | P=.04 at day 30 | were significantly less | #4 |
consumer-based mobile meditation application (app) | decrease | self-reported anxiety | outpatient obstetric and gynecology patients during the COVID-19 pandemic | P=.01 at day 14 | were significantly less | #5 |
consumer-based mobile meditation application (app) | decrease | self-reported anxiety | outpatient obstetric and gynecology patients during the COVID-19 pandemic | P=.04 at day 30 | were significantly less | #6 |
consumer-based mobile meditation application (app) | decrease | sleep disturbance | outpatient obstetric and gynecology patients during the COVID-19 pandemic | P=.001 at day 14 | was significantly less | #7 |
consumer-based mobile meditation application (app) | decrease | sleep disturbance | outpatient obstetric and gynecology patients during the COVID-19 pandemic | P=.02 at day 30 | was significantly less | #8 |
consumer-based mobile meditation application (app) | increase | satisfaction with the meditation app | intervention group | More than 80% | reported high satisfaction | #9 |
mindfulness meditation | increase | stress | intervention group | 93% reported | improved | #10 |
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.