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

NCT05087329 | Terminated

• 1 other identifier: 843962
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Prenatal Stress

Outcome Measures

Primary Outcomes (1)

• Decrease in Maternal Stress

  Change in score on Perceived Stress Scale (PSS)

  6 to 8 weeks

Secondary Outcomes (2)

• Composite score of maternal morbidity/pregnancy outcomes

  6 to 8 weeks post-delivery

• Change in score on Edinburgh Postnatal Depression Scale

  change between score at time of delivery and 6 weeks

Study Arms (2)

Virtual Mindfulness intervention

EXPERIMENTAL

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

Behavioral: Virtual Mindfulness Meditation

Standard of Care

NO INTERVENTION

Interventions

Virtual Mindfulness Meditation BEHAVIORAL

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

Virtual Mindfulness intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age \< 18

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadephia, Pennsylvania, 19104, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assitant Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: October 21, 2021
• Study Start: May 5, 2021
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)