Abstract

Up to 70% of pregnant individuals experience anxiety, and mindful meditation offers a non-pharmacologic treatment. Prior studies of mindful meditation to reduce anxiety largely excluded cohorts admitted with complications to the antepartum unit (AU), who experience higher levels of anxiety. Our objective was to compare anxiety scores among those admitted to the AU after 3 days of a mindful meditation program, versus controls. In this multi-center, randomized controlled trial, individuals at ≥ 23 weeks gestation and admitted to the AU were randomized: 1) control group or 2) routine care plus a twice-daily app-based mindful meditation program. The primary outcome was maternal anxiety score (using the validated State Trait Anxiety Inventory [STAI]) on day 4. Secondary outcomes included stress and depression levels, latency and patient satisfaction. Analysis was by intention-to-treat. A pre-study calculation required 56 people for 90% power to detect a decrease in the primary outcome by 30% (2-tailed, α=0.05), accounting for 50% loss to delivery or discharge before day 4. Of 412 individuals screened, 77 were eligible, and 56 were randomized (28 per group). The intervention group had a mean of 4.0 (standard deviation, SD 2.1) sessions and 40.0 (SD 27.8) minutes of meditation. The primary outcome, STAI anxiety score on day 4, was not significantly different (p=0.24). Change in STAI from day 1 to day 4, and rates of abnormal STAI scores at day 4, were similar. Stress and depression scores at day 4 were similar, as was latency from randomization to delivery. More than 80% in both groups stated a positive experience with the trial. (Table 1) Compared to controls, a twice-daily app-based mindful meditation program for individuals admitted to antepartum did not significantly decrease anxiety on day 4. Both groups had at least 30% abnormal levels of anxiety, stress and depression on day 4. With more than 80% having a positive experience, future studies are feasible.

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