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

Not Applicable

Terminated

• Conditions: Prenatal Stress
• Interventions: Behavioral: Virtual Mindfulness Meditation

• Registration Number: NCT05087329
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-05-05
• Study First Submitted: 2021-10-19
• Study First Submitted QC: 2021-10-19
• Study First Posted: 2021-10-21
• Status Verified: 2024-02
• Primary Completion: 2024-09-19
• Study Completion: 2024-09-19
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 43

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Mindfulness intervention	Virtual Mindfulness Meditation	Four weekly group Zoom webinars with a 15-20 minute pre-recorded meditation

Primary Outcome Measures

Name	Time	Method
Decrease in Maternal Stress	6 to 8 weeks	Change in score on Perceived Stress Scale (PSS)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadephia, Pennsylvania, United States