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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05087329
Recruitment Status : Recruiting
First Posted : October 21, 2021
Last Update Posted : November 17, 2021
Sponsor:
Information provided by (Responsible Party):
Kirstin Leitner, University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Prenatal Stress Behavioral: Virtual Mindfulness Meditation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness Practice in Pregnancy as an Intervention to Decrease Prenatal Stress During the COVID-19 Pandemic
Actual Study Start Date : May 5, 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Virtual Mindfulness intervention
Four weekly group Zoom webinars with a 15-20 minute pre-recorded meditation
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

No Intervention: Standard of Care



Primary Outcome Measures :
  1. Decrease in Maternal Stress [ Time Frame: 6 to 8 weeks ]
    Change in score on Perceived Stress Scale (PSS)


Secondary Outcome Measures :
  1. Composite score of maternal morbidity/pregnancy outcomes [ Time Frame: 6 to 8 weeks post-delivery ]
  2. Change in score on Edinburgh Postnatal Depression Scale [ Time Frame: change between score at time of delivery and 6 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05087329


Contacts
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Contact: Kirstin Leitner, MD 651-492-3856 kirstin.leitner@pennmedicine.upenn.edu
Contact: Meaghan McCabe meghan.mccabe@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kirsten Leitner, MD       kirsten.leitner@pennmedicine.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
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Responsible Party: Kirstin Leitner, Assitant Professor of Obstetrics and Gynecology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT05087329    
Other Study ID Numbers: 843962
First Posted: October 21, 2021    Key Record Dates
Last Update Posted: November 17, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases