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

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

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

Conditions
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Prenatal Stress

Intervention / Treatment
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* Behavioral: Virtual Mindfulness Meditation


Participation Criteria
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Eligibility Criteria
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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. Age < 18

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Mindfulness intervention<br>Four weekly group Zoom webinars with a 15-20 minute pre-recorded meditation | Behavioral: Virtual Mindfulness Meditation<br>* 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<br>|
| No Intervention: Standard of Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Maternal Stress | Change in score on Perceived Stress Scale (PSS) | 6 to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |