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NCT04264910 · ClinicalTrials.gov registry record · NA
CALM Pregnancy: Feasibility of Calm for Pregnant Women
A NA study, sponsored by Arizona State University.
- Completed
- Registry status
- NA
- Development phase
- 97
- Enrollment target
NCT04264910 is a NA study that has completed, run by Arizona State University. The registered enrollment target is 97 participants.
The verdict
NCT04264910, a NA study, has completed, sponsored by Arizona State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 97 participants
- Enrollment target
Study Summary
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).
Interventions
- BEHAVIORAL Calm App
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2021-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04264910
The ClinicalTrials.gov registry entry for NCT04264910 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 97 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arizona State University, which has 187 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Calm App is the first listed.
NCT04264910 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04264910 about?
NCT04264910 is a clinical study titled "CALM Pregnancy: Feasibility of Calm for Pregnant Women". 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 meditati...
What is the current status of trial NCT04264910?
This trial is currently completed. It is a NA study. The enrollment target is 97 participants. The study started on 2019-11-01. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT04264910?
The interventions under investigation include: Calm App (BEHAVIORAL).
Who is sponsoring clinical trial NCT04264910?
This trial is sponsored by Arizona State University, which has 187 total clinical trials registered on ClinicalTrials.gov.
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