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Study Examining Stress During Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by University of Virginia.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Arizona
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00307320
First received: March 24, 2006
Last updated: December 29, 2009
Last verified: August 2008
History of Changes
  Purpose

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 Intervention
Stress
 Behavioral: Relaxation Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Coping With Stress During Pregnancy

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by University of Virginia:

Estimated Enrollment: 40
Study Start Date: March 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Experimental: 2
Relaxation techniques
 Behavioral: Relaxation Training
Relaxation techniques training

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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00307320     History of Changes
Other Study ID Numbers: HIC 12234
Study First Received: March 24, 2006
Last Updated: December 29, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
pregnancy
stress
anxiety

ClinicalTrials.gov processed this record on June 18, 2013