Mindfulness Practice in Pregnancy As an Intervention to Decrease Prenatal Stress During the COVID-19 Pandemic (CALMS)

October 11, 2024 updated by: Kirstin Leitner, University of Pennsylvania
The purpose of the study is to examine whether a simple mindfulness intervention conducted via a virtual platform can reduce stress among pregnant women.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadephia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Women between 16w0d-26w6d gestation with a single gestation who have had a confirmed dating ultrasound

    a. Only women with singleton gestations will be included because multiple gestation pregnancies introduce additional levels of stress and introduce confounding variables for the adverse composite pregnancy outcome that will be measured. As this is a study of pregnant patients, only women are included.

  2. English speaking

    a. The mindfulness meditation trainings have been scripted and recorded in English. Thus, to understand the recordings and participate in the courses it is necessary for all participants to speak English.

  3. Regular internet access through either phone, tablet or computer. a. Mindfulness meditations are administered via Zoom webinars so internet access is required. A proxy for internet access during recruitment will be confirmed by the inclusion of an email address in the electronic medical record (EMR).

Exclusion Criteria:

  1. Multiple gestations. This has been chosen as an exclusion criteria to limit confounding variables for the secondary outcome of composite adverse pregnancy events.
  2. Age < 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of Care
Experimental: Virtual Mindfulness intervention
Four weekly group Zoom webinars with a 15-20 minute pre-recorded meditation
Behavioral: Virtual Mindfulness Meditation
Four week virtual mindfulness meditation course composed of four weekly group Zoom webinars during which participants will listen to a 15-20 minute pre-recorded meditation, facilitated by a study provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in Maternal Stress
Time Frame: 6 to 8 weeks
Change in score on Perceived Stress Scale (PSS)
6 to 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Composite score of maternal morbidity/pregnancy outcomes
Time Frame: 6 to 8 weeks post-delivery
6 to 8 weeks post-delivery
Change in score on Edinburgh Postnatal Depression Scale
Time Frame: change between score at time of delivery and 6 weeks
change between score at time of delivery and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2021

Primary Completion (Actual)

September 19, 2024

Study Completion (Actual)

September 19, 2024

Study Registration Dates

First Submitted

October 19, 2021

First Submitted That Met QC Criteria

October 19, 2021

First Posted (Actual)

October 21, 2021

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 843962

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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