Study Examining Stress During Pregnancy

Stress Clinical Trial

Official title:

Coping With Stress During Pregnancy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00307320
• Other study ID #: HIC 12234
• Status: Active, not recruiting
• Phase: N/A
• First received: March 24, 2006
• Last updated: December 29, 2009
• Start date: March 2006
• Est. completion date: December 2009

Study information

• Verified date: August 2008
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• Relaxation Training
Relaxation techniques training

Locations

Country	Name	City	State
United States	University of Virginia, Department of Psychology	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	University of Arizona

Country where clinical trial is conducted

United States,