NCT05087329TerminatedNot Applicable
Mindfulness Practice in Pregnancy As an Intervention to Decrease Prenatal Stress During the COVID-19 Pandemic
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Pennsylvania
- Enrollment
- 43
- Locations
- 1
- Primary Endpoint
- Decrease in Maternal Stress
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Virtual Mindfulness intervention
Experimental
Four weekly group Zoom webinars with a 15-20 minute pre-recorded meditation
Intervention: Virtual Mindfulness Meditation (Behavioral)
Standard of Care
No Intervention
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)
Investigators
Kirstin Leitner
Assitant Professor of Obstetrics and Gynecology
University of Pennsylvania
Study Sites (1)
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