Overview

This trial is active, not recruiting.

Condition stress
Treatment relaxation training
Sponsor University of Virginia
Collaborator University of Arizona
Start date March 2006
End date December 2009
Trial size 40 participants
Trial identifier NCT00307320, HIC 12234

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
(Experimental)
Relaxation techniques
relaxation training
Relaxation techniques training

Eligibility Criteria

Female participants from 18 years up to 40 years old.

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

Additional Information

Official title Coping With Stress During Pregnancy
Principal investigator Susan Kirk, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in December 2009.
Information provided to ClinicalTrials.gov by University of Virginia.