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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05087329

Acronym

CALMS

Enrollment

Registered

2021-10-21

Start date

2021-05-05

Completion date

2024-09-19

Last updated

2024-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prenatal Stress

Brief 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.

Interventions

BEHAVIORALVirtual 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Decrease in Maternal Stress	6 to 8 weeks	Change in score on Perceived Stress Scale (PSS)

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026