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Study Examining Stress During Pregnancy

NCT ID: NCT00307320

Last Updated: 2009-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-12-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Stress

Keywords

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pregnancy stress anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Relaxation techniques

Group Type EXPERIMENTAL

Relaxation Training

Intervention Type BEHAVIORAL

Relaxation techniques training

Interventions

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Relaxation Training

Relaxation techniques training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Arizona

OTHER

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Principal Investigators

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Andrea Chambers, MA

Role: STUDY_DIRECTOR

University of Virginia / University of Arizona

Susan Kirk, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia, Department of Psychology

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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HIC 12234

Identifier Type: -

Identifier Source: org_study_id