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additional studies in this specific population made continuing with RCT unnecessary so became a part of clinical care
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Mindfulness intervention | Experimental | Four weekly group Zoom webinars with a 15-20 minute pre-recorded meditation |
|
| Standard of Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Mindfulness Meditation | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in Maternal Stress | Change in score on Perceived Stress Scale (PSS) | 6 to 8 weeks |
| 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 |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadephia | Pennsylvania | 19104 | United States |
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