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

Prenatal Stress Clinical Trial

— CALMS  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05087329
• Other study ID #: 843962
• Status: Suspended
• Phase: N/A
• Start date: May 5, 2021
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 248
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Prenatal Stress

Intervention

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

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in Maternal Stress	Change in score on Perceived Stress Scale (PSS)	6 to 8 weeks
Secondary	Composite score of maternal morbidity/pregnancy outcomes		6 to 8 weeks post-delivery
Secondary	Change in score on Edinburgh Postnatal Depression Scale		change between score at time of delivery and 6 weeks