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Study Examining Stress During Pregnancy

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ClinicalTrials.gov Identifier: NCT00307320
Recruitment Status : Unknown
Verified August 2008 by University of Virginia.
Recruitment status was:  Active, not recruiting
First Posted : March 27, 2006
Last Update Posted : December 30, 2009
Sponsor:
Collaborator:
University of Arizona
Information provided by:
University of Virginia

Brief Summary:
Researchers at UVa Health System are interested in how women experience and deal with stress during pregnancy. Participants will be randomly assigned either to engage in coping strategies on one's own or to receive 6 weeks of relaxation training. Researchers will examine how coping strategies affect the course of the pregnancy and the health of the infant

Condition or disease Intervention/treatment Phase
Stress Behavioral: Relaxation Training Not Applicable

Detailed Description:

Participants will be asked to fill out questionnaires and complete some tasks that require concentration as heart rate and other biological signals are monitored. Participants will also be asked to provide samples of saliva a few times during 1 day. These tasks will be repeated 3 times during pregnancy and participants will be asked to complete questionnaires at 6 months postpartum

A stress-reduction workshop will be offered to all participants at the completion of the study.

Participants will be paid for study completion


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Coping With Stress During Pregnancy
Study Start Date : March 2006
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Arm Intervention/treatment
No Intervention: 1
Experimental: 2
Relaxation techniques
Behavioral: Relaxation Training
Relaxation techniques training




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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • beginning of the 2nd trimester of pregnancy
  • feel stressed or overwhelmed
  • do not yet have any children

Exclusion Criteria:

  • more than 1 miscarriage
  • currently receiving medication for anxiety or depression

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): NCT00307320


Locations
United States, Virginia
University of Virginia, Department of Psychology
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
University of Arizona
Investigators
Study Director: Andrea Chambers, MA University of Virginia / University of Arizona
Principal Investigator: Susan Kirk, MD University of Virginia

ClinicalTrials.gov Identifier: NCT00307320     History of Changes
Other Study ID Numbers: HIC 12234
First Posted: March 27, 2006    Key Record Dates
Last Update Posted: December 30, 2009
Last Verified: August 2008

Keywords provided by University of Virginia:
pregnancy
stress
anxiety