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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-05

Study Completion Date

2024-09-19

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.

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Detailed Description

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Conditions

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Prenatal Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Virtual Mindfulness intervention

Four weekly group Zoom webinars with a 15-20 minute pre-recorded meditation

Group Type EXPERIMENTAL

Virtual Mindfulness Meditation

Intervention Type 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

Standard of Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).