CALM Pregnancy: Feasibility of Calm for Pregnant Women

Completed · Not applicable

Conditions studied: Pregnant Women

In brief

The purpose of this study is to determine the feasibility of using a consumer-based mindfulness app, Calm, to reduce stress during pregnancy. Women will be randomly assigned to an intervention group (i.e., Calm) or standard care group and asked to participate in at least 10 minutes of daily meditation for the duration of their pregnancy (i.e., 12-weeks' gestation up to date of birth). Aim #1: Determine the feasibility (acceptability and demand) of using the Calm app at least 10-minutes per day for the duration of pregnancy (i.e., 12-weeks' gestation up to date of birth). Acceptability will be measured with an investigator-developed satisfaction survey. Demand will be measured using time spent in meditation and meditations used (tracked by Calm). For the intervention group, the benchmarks will be as follows: 1. Acceptability (i.e., satisfaction) 70% (n=34) of participants will report a 75% satisfaction, 2. Demand (i.e., time spent in meditation and meditations used,) 70% (n=34) of participants will adhere to ≥75% of prescribed meditation using Calm. Aim #2: Determine the preliminary effects of using Calm at least 10-minutes per day for the duration of pregnancy (i.e., 12-16 weeks' gestation to date of birth) on stress. Stress will be measured using the Perceived Stress Scale (PSS) at baseline (i.e., 12-16-weeks' gestation) and every four weeks for the duration of the intervention using Ecological Momentary Assessment (i.e., text message). Stress will also be measured using cortisol serum at baseline (i.e., 12-16-weeks' gestation), and 32 weeks' gestation. Exploratory Aim #3: The investigators will explore the preliminary effects of using Calm at least 10-minutes per day for the duration of pregnancy (i.e., 12-16 weeks' gestation to date of birth) on gestational age of birth, fetal weight, APGAR scores (i.e., health score), and neonatal complications with time spent in neonatal intensive unit (if applicable).

Key facts

Study ID

NCT04264910

Run by

Arizona State University

People needed

97

Starts

2019-11-01

Expected to finish

2021-06-30

Last updated by the study team

2022-07-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• women 12-16 weeks pregnant
• 18 years of age
• English speaking
• not currently on steroid therapy
• willing to download the Calm app to their smartphone,
• have not practiced meditation or mindful movement more than 60 minutes a month in the past six months
• willing to be randomized to one of two groups.

You may not qualify if…

• N/A

Where it is running

• Arizona Biomedical Collaborative — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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