Study Examining Stress During Pregnancy | NCT00307320

Studies
Study Examining Stress During Pregnancy

NCT00307320

Sponsor

University of Virginia

Status

Unknown status

Last Update Posted

Dec 30, 2009Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Stress

Interventions

Relaxation Training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2006

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Mar 24, 2006

First Submission Date that Met QC Criteria

Mar 24, 2006

First Posted Date

Mar 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2009

Last Update Posted Date

Dec 30, 2009Estimated

Name	Class
University of Arizona	OTHER

Description Module

Brief 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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	No Intervention
2	Experimental	Relaxation techniques	Behavioral: Relaxation Training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Relaxation Training	Behavioral	Relaxation techniques training	2

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrea Chambers, MA	University of Virginia / University of Arizona	Study Director
Susan Kirk, MD	University of Virginia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Virginia, Department of Psychology		Charlottesville	Virginia	22908	United States

ID	Term
D001008	Anxiety Disorders

ID	Term
D001523	Mental Disorders

Intervention Browse Module

MeSH Terms

ID	Term
D012064	Relaxation Therapy

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics
D001521	Behavior Therapy

Browse Leaves

Not provided

Browse Branches

Not provided