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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: Completed NA study, sponsored by Arizona State University.
NCT04264910 is a NA study that has completed, run by Arizona State University. The registered enrollment target is 97 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Acceptability will be measured with an investigator developed survey
Interventions
- BEHAVIORAL Calm App
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2021-06-30 |
| Phase | NA |
What the finished NCT04264910 record still lists
NCT04264910 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Calm App is the first listed.
NCT04264910 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04264910's enrollment target sits among peer trials
97 923rd of 2000 higher than 1,076 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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