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

University of Pennsylvania1 site in 1 country43 target enrollmentMay 5, 2021

ConditionsPrenatal Stress

Overview

Phase: N/A
Intervention: Not specified
Conditions: Prenatal Stress
Sponsor: University of Pennsylvania
Enrollment: 43
Locations: 1
Primary Endpoint: Decrease in Maternal Stress
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 5, 2021

End Date

September 19, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Pennsylvania

Responsible Party

Principal Investigator

Kirstin Leitner

Assitant Professor of Obstetrics and Gynecology

University of Pennsylvania

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.

Outcomes

Primary Outcomes

Decrease in Maternal Stress

Time Frame: 6 to 8 weeks

Change in score on Perceived Stress Scale (PSS)

Secondary Outcomes

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)