Daily Meditation Program for Anxiety in Individuals Admitted to the Antepartum Unit: A Multi-Center Randomized Controlled Trial (MEDITATE).

Background: Inpatient antepartum individuals have higher levels of anxiety compared to outpatient. Former randomized trials using mindful meditation programs to decrease maternal anxiety have conflicting results; some studies show significant decrease in anxiety levels, while others show no difference. A paucity of trials exist using mindful meditation for maternal anxiety in the inpatient antepartum population; most studies focus on the outpatient clinic population. Due to inpatient acuity and anxiety factors, we performed a randomized trial to target this population.

Objective: To compare anxiety levels on day 4 of either routine care or routine care plus an application-based twice-daily mindful meditation program in individuals admitted to the antepartum unit. STUDY DESIGN In a multi-site randomized trial (NCT03737279), individuals admitted to the antepartum units were randomized to either routine care plus educational pamphlets (control arm) or routine care plus a twice-daily application-based mindful meditation program (intervention arm). Inclusion criteria were age of at least 18 years, gestational age of at least 23 weeks, planned inpatient care for more than 3 days from randomization, and care by our university physician team. The primary outcome was maternal state anxiety level (measured by the validated State Trait Anxiety Inventory, STAI) on day 4 (randomization being day 1). Secondary outcomes included stress (measured by Perceived Stress Scale, PSS) and depression (measured by Edinburgh Depression Scale, EDS) on day 4, latency period from randomization to delivery, patient experience, number of meditation sessions, and total meditation time. A total of 56 women were needed for 90% power to detect a decrease in the primary outcome by 30% in intervention group, compared to controlled group. All women were analyzed by intention to treat analysis. We compared continuous variables using Wilcoxon or t test, and categorical variables using chi-square or Fisher's exact test.

Results: From March 4, 2019 through December 20, 2019, 412 women were screened for eligibility, 77 (18.7%) found eligible, and 56 (72.7%) randomized with 28 in each group. 96.4% of individuals completed at least 1 meditation session, and 39.3% completed all meditation sessions. The mean score of STAI anxiety level at day 4 was not significantly different (p=0.24) between the control group (42.0 ± 10.8) and the meditation group (37.5 ± 13.1). A decreased anxiety score from day 1 to day 4 was seen in both the control group (- 4.7) and the meditation group (- 9.4, p=0.12). The rate of abnormal STAI scores at day 4 was not significantly different between the control group (62%) and the meditation group (45%, p=0.28). When asked about the experience with the research trial, 88.8% in the control group and 89.5% in the meditation group reported a positive experience.

Conclusions: Compared to a control group, a twice-daily application-based mindful meditation program for women admitted to the antepartum unit did not significantly decrease anxiety score on day 4. However, more than 88% of women in both groups had a positive experience with this non-pharmacologic intervention. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT03737279.