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

University of Pennsylvania

Status: Terminated

Conditions: Prenatal Stress

Treatments: Behavioral: Virtual Mindfulness Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT05087329

843962

Details and patient eligibility

About

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

Enrollment: 43 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 2 patient groups

Virtual Mindfulness intervention

Experimental group

Description:

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

Treatment:

Behavioral: Virtual Mindfulness Meditation

Standard of Care

No Intervention group