Effectiveness of Guided Imagery Intervention on Factors Associated With Maternal Stress and Preterm Birth
Primary Purpose
Preterm Birth, Maternal Stress
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guided Imagery
Sponsored by

About this trial
This is an interventional screening trial for Preterm Birth focused on measuring cytokines, Guided imagery
Eligibility Criteria
Inclusion Criteria:
- Being pregnant between 14-17 weeks gestation
- Being African American
- 18 years of age or older
- able to read, write and understand English
- verbalize a source of social support
- self-report of no change in level of stress management strategies used within the last month.
Exclusion Criteria:
- carrying multiples
- have had cervical cerclage
- currently use oral corticosteroids
- have uterine or cervical abnormality
- have dissociative disorders, borderline personalities or psychotic pathology
- have medical and/or pregnancy complications known to impact cytokine levels (e.g., gestational diabetes)
- currently use GI techniques.
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Guided Imagery Intervention
Control group
Arm Description
The 12 week intervention consists of a set of 4 GI compact discs (CDs), each 20 minutes in length. Participants will be instructed to listen to the CD once a day in a recommended order for weeks 1-4 and used in any order for weeks 5-12.
continues usual plan of care
Outcomes
Primary Outcome Measures
maternal stress (perceived stress)
maternal stress (perceived stress)
maternal stress (perceived stress)
Secondary Outcome Measures
neuroendocrine (CRH) and immunological mediators (IL-1β, IL-6, Il-8, IL-10, IL-12, TNF-α, IFN-γ, G-CSF, GM-CSF)
neuroendocrine (CRH) and immunological mediators (IL-1β, IL-6, Il-8, IL-10, IL-12, TNF-α, IFN-γ, G-CSF, GM-CSF)
neuroendocrine (CRH) and immunological mediators (IL-1β, IL-6, Il-8, IL-10, IL-12, TNF-α, IFN-γ, G-CSF, GM-CSF)
Full Information
NCT ID
NCT01436786
First Posted
September 6, 2011
Last Updated
May 14, 2014
Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Nursing Research (NINR)
1. Study Identification
Unique Protocol Identification Number
NCT01436786
Brief Title
Effectiveness of Guided Imagery Intervention on Factors Associated With Maternal Stress and Preterm Birth
Official Title
Guided Imagery Effects on Pregnancy Symptoms and Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Nursing Research (NINR)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Demonstrating the effectiveness of an economical and feasible intervention such as guided imagery on factors associated with preterm birth, along with better understanding of pathways leading to adverse birth outcomes has tremendous health, social, and financial benefits. This project has the potential to significantly advance the field of nursing and knowledge development in the areas of maternal stress reduction in African American women and to provide scientific evidence of the effectiveness of guided imagery.
Detailed Description
Preterm birth (PTB) is the leading cause of neonatal morbidity and mortality and has tremendous health and economic costs for the infant, family, and society. There has been little success in reducing PTB; rates are at an all time high. Of particular concern is the major racial disparity in PTB rates; African American women have the highest proportion of PTB compared to women of other races or ethnicities. There is growing evidence suggesting that PTB may be the end point of sub-acute or chronic pathophysiological changes that occur before clinical symptoms of preterm labor are present. There is also evidence to suggest that psychosocial factors such as maternal stress and the related symptoms of fatigue, anxiety, depression, as well as unhappiness about the pregnancy are associated with negative birth outcomes. It is proposed that these behavioral factors could influence birth outcomes through two possible pathways: (1) a neuroendocrine pathway in which maternal stress may lead to early and/or greater activation of the maternal-placental-fetal endocrine systems, with CRH playing a key role, thereby promoting labor; and/or (2) immunologic or inflammatory pathways which may promote labor through pro-inflammatory mechanisms. Experts agree primary prevention interventions are needed to address the issue of PTB. Guided imagery (GI) has been effective in decreasing self-reported measures of stress, depression, and fatigue as well as influencing neuroendocrine and immune measures in the general population. However, there are only limited studies examining the effects of GI on maternal stress, neuroendocrine measures, and/or birth outcomes, and there are no published studies examining the effect of GI as a primary prevention intervention to improve birth outcomes by reducing stress and related symptoms and influencing the proposed immunologic pathway to PTB. The specific aims of this randomized clinical trial are (1) to test the effects of a GI intervention on maternal stress (perceived stress), related symptoms (fatigue, anxiety, depression, and unhappiness), neuroendocrine (CRH) and immunological mediators (IL-1β, IL-6, Il-8, IL-10, IL-12, TNF-α, IFN-γ, G-CSF, GM-CSF), and birth outcomes (gestational age and neonatal birthweight) in African American women; and (2) to test the proposed theoretical model by examining predicted relationships among stress, fatigue, anxiety, depression, unhappiness, patterns of neuroendocrine and immunologic factors, and birth outcomes. An analysis of covariance (ANCOVA) model will be used to test for group differences between the GI and control groups. To test the proposed theoretical model descriptive statistics, graphical methods and pairwise correlations will be calculated for all baseline data and canonical correlation analysis will be used to look for relationship among groups of the baseline variables. Demonstrating the effectiveness of an economical, easy to distribute and use, intervention on the psychosocial factors associated with PTB and the proposed pathways leading to adverse birth outcomes has tremendous health, social and financial benefits. This project will provide baseline data for further research to test the biobehavioral efficacy of this intervention in larger samples with multiple races/ethnicities as well as test the model during the postpartum period for maternal well-being and infant development.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth, Maternal Stress
Keywords
cytokines, Guided imagery
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Guided Imagery Intervention
Arm Type
Experimental
Arm Description
The 12 week intervention consists of a set of 4 GI compact discs (CDs), each 20 minutes in length. Participants will be instructed to listen to the CD once a day in a recommended order for weeks 1-4 and used in any order for weeks 5-12.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
continues usual plan of care
Intervention Type
Other
Intervention Name(s)
Guided Imagery
Intervention Description
The 12 week intervention consists of a set of 4 GI compact discs (CDs), each 20 minutes in length. Participants will be instructed to listen to the CD once a day in a recommended order for weeks 1-4 and used in any order for weeks 5-12.
Primary Outcome Measure Information:
Title
maternal stress (perceived stress)
Time Frame
baseline
Title
maternal stress (perceived stress)
Time Frame
8th Week
Title
maternal stress (perceived stress)
Time Frame
12th Week
Secondary Outcome Measure Information:
Title
neuroendocrine (CRH) and immunological mediators (IL-1β, IL-6, Il-8, IL-10, IL-12, TNF-α, IFN-γ, G-CSF, GM-CSF)
Time Frame
baseline
Title
neuroendocrine (CRH) and immunological mediators (IL-1β, IL-6, Il-8, IL-10, IL-12, TNF-α, IFN-γ, G-CSF, GM-CSF)
Time Frame
8th Week
Title
neuroendocrine (CRH) and immunological mediators (IL-1β, IL-6, Il-8, IL-10, IL-12, TNF-α, IFN-γ, G-CSF, GM-CSF)
Time Frame
12th Week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Being pregnant between 14-17 weeks gestation
Being African American
18 years of age or older
able to read, write and understand English
verbalize a source of social support
self-report of no change in level of stress management strategies used within the last month.
Exclusion Criteria:
carrying multiples
have had cervical cerclage
currently use oral corticosteroids
have uterine or cervical abnormality
have dissociative disorders, borderline personalities or psychotic pathology
have medical and/or pregnancy complications known to impact cytokine levels (e.g., gestational diabetes)
currently use GI techniques.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Jallo, PhD
Organizational Affiliation
VCU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Guided Imagery Intervention on Factors Associated With Maternal Stress and Preterm Birth
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