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| Sponsors and Collaborators: |
University of Virginia University of Arizona |
|---|---|
| Information provided by: | University of Virginia |
| ClinicalTrials.gov Identifier: | NCT00307320 |
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: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Coping With Stress During Pregnancy |
| 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 |
|---|---|
| 1: No Intervention | |
|
2: Experimental
Relaxation techniques
|
Behavioral: Relaxation Training
Relaxation techniques training
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Virginia | |
| University of Virginia, Department of Psychology | |
| Charlottesville, Virginia, United States, 22908 | |
| Study Director: | Andrea Chambers, MA | University of Virginia / University of Arizona |
| Principal Investigator: | Susan Kirk, MD | University of Virginia |
More Information
| Study ID Numbers: | HIC 12234 |
| Study First Received: | March 24, 2006 |
| Last Updated: | August 6, 2008 |
| ClinicalTrials.gov Identifier: | NCT00307320 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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pregnancy stress anxiety |
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Stress |
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Pathologic Processes Stress |
