Status:
TERMINATED
Feasibility of Calm to Reduce Stress and Improve Sleep During Pregnancy
Lead Sponsor:
Calm.com, Inc.
Conditions:
Pregnancy Related
Eligibility:
FEMALE
18-99 years
Phase:
NA
Brief Summary
Purpose: Test the effects of using Calm for its impact on stress, anxiety, and sleep in pregnant women using the following aims: Aim #1: Determine the feasibility of using Calm. Aim #2: Determine th...
Detailed Description
Rates of stress and poor sleep affect up to 70% of pregnant women with rates even higher in racial and ethnic minority (REM) women. Stress and poor sleep are often untreated or misdiagnosed, especiall...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Pregnant women 14-16 or 28-30 weeks gestation
- Resident of United States
- Access to regular WiFI
- Access to a smartphone regularly
- Willing to download an app onto their smartphone
- Score of \>13 on Perceived Stress Scale (PSS-10)\] 31 and sleep quality \[score of \>5 on Pittsburgh Sleep Quality Index (PSQI)\]
- Have not practiced meditation more than 60 minutes a month in the past six months
- Willing to be randomized to one of two groups.
- Exclusion Criteria:
- \<18 years of age
- Unable to consent
- First trimester (less than 14 weeks)
Exclusion
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT05285956
Start Date
March 1 2022
End Date
August 1 2022
Last Update
August 22 2022
Active Locations (1)
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1
Calm, Inc.
San Francisco, California, United States, 94105