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Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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).

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Virtual Mindfulness intervention 		Four weekly group Zoom webinars with a 15-20 minute pre-recorded meditation
  • Behavioral: Virtual Mindfulness Meditation
    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
No Intervention
Standard of Care

Recruiting Locations

More Details

NCT ID
NCT05087329
Status
Terminated
Sponsor
University of Pennsylvania

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.