Expired Study
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Nashville, Tennessee 37240


Purpose:

The purpose of this study was to evaluate the effect of guided imagery on the third stage of labor. Blood loss from hemorrhage during childbirth, most commonly due to uterine atony, is one of the leading causes of maternal mortality in the United States and the leading cause of maternal death worldwide. The hypothesis was that the use of physiologic guided imagery would reduce the amount of bleeding during the third stage of labor.


Criteria:

Inclusion Criteria: - 18 years of age or older but less than 35 years - English as her primary language - fetus in a cephalic presentation - singleton pregnancy - 36 to 38 estimated gestational weeks - no contraindications to vaginal delivery - maternal weight less than 200 pounds prior to pregnancy Exclusion Criteria: - more than four previous children - a history of postpartum hemorrhage - bleeding disorder - seizure disorder - polyhydramnios - diabetes (including gestational) - hypertension - cardiac disease - uterine fibroids - anemia (hematocrit less than 30) - intrauterine fetal demise or tobacco use


Study is Available At:


Original ID:

070035


NCT ID:

NCT00826735


Secondary ID:


Study Acronym:


Brief Title:

The Effect of Guided Imagery on the Third Stage of Labor


Official Title:

The Effect of Guided Imagery on the Third Stage of Labor


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

34 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanderbilt University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Prevention


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Mavis N Schorn, PhD
Principal Investigator
Vanderbilt University School of Nursing

Study Dates

Start Date:January 2007
Completion Date:December 2007
Completion Type:Actual
Primary Completion Date:December 2007
Primary Completion Type:Actual
Verification Date:January 2009
Last Changed Date:January 21, 2009
First Received Date:January 20, 2009

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Length of third stage of labor
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Blood Loss
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Guided imagery
Description:A relaxation focused guided imagery intervention was used through the remainder of pregnancy plus a physiologic guided imagery intervention was used during the third stage of labor.
Arm Name:Guided imagery

Study Arms

Study Arm Type:Experimental
Arm Name:Guided imagery
Description:The experimental group received a relaxation focused guided imagery intervention to use through the remainder of pregnancy plus a physiologic guided imagery intervention during the third stage of labor. These interventions were scripted and prerecorded on CDs.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Vanderbilt University
Agency Class:Other
Agency Type:Collaborator
Agency Name:Sigma Theta Tau International, Iota chapter

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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