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

Primary Purpose

Prenatal Stress

Status

Suspended

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Virtual Mindfulness Meditation

About this trial

This is an interventional treatment trial for Prenatal Stress

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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.
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.
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:

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

Sites / Locations

University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Mindfulness intervention

Standard of Care

Arm Description

Four weekly group Zoom webinars with a 15-20 minute pre-recorded meditation

Outcomes

Primary Outcome Measures

Decrease in Maternal Stress

Change in score on Perceived Stress Scale (PSS)

Secondary Outcome Measures

Composite score of maternal morbidity/pregnancy outcomes

Change in score on Edinburgh Postnatal Depression Scale

Full Information

NCT ID

NCT05087329

First Posted

October 19, 2021

Last Updated

April 4, 2023

Sponsor

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT05087329

Brief Title

Mindfulness Practice in Pregnancy as an Intervention to Decrease Prenatal Stress During the COVID-19 Pandemic

Acronym

CALMS

Official Title

Mindfulness Practice in Pregnancy as an Intervention to Decrease Prenatal Stress During the COVID-19 Pandemic

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Suspended

Why Stopped

to review recruitment strategies

Study Start Date

May 5, 2021 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to examine whether a simple mindfulness intervention conducted via a virtual platform can reduce stress among pregnant women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prenatal Stress

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

248 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Virtual Mindfulness intervention

Arm Type

Experimental

Arm Description

Four weekly group Zoom webinars with a 15-20 minute pre-recorded meditation

Arm Title

Standard of Care

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

Virtual Mindfulness Meditation

Intervention Description

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

Primary Outcome Measure Information:

Title

Decrease in Maternal Stress

Description

Change in score on Perceived Stress Scale (PSS)

Time Frame

6 to 8 weeks

Secondary Outcome Measure Information:

Title

Composite score of maternal morbidity/pregnancy outcomes

Time Frame

6 to 8 weeks post-delivery

Title

Change in score on Edinburgh Postnatal Depression Scale

Time Frame

change between score at time of delivery and 6 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Mindfulness Practice in Pregnancy as an Intervention to Decrease Prenatal Stress During the COVID-19 Pandemic

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