Effectiveness of Guided Imagery Intervention on Factors Associated With Maternal Stress and Preterm Birth

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01436786
First received: September 6, 2011
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Preterm Birth
Maternal Stress
Other: Guided Imagery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Guided Imagery Effects on Pregnancy Symptoms and Outcomes

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • maternal stress (perceived stress) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • maternal stress (perceived stress) [ Time Frame: 8th Week ] [ Designated as safety issue: No ]
  • maternal stress (perceived stress) [ Time Frame: 12th Week ] [ Designated as safety issue: No ]

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) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 73
Study Start Date: June 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Guided Imagery Intervention
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.
Other: Guided Imagery
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.
No Intervention: Control group
continues usual plan of care

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436786

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Nancy Jallo, PhD, RNC, FNP-BC, CNS VCU
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01436786     History of Changes
Other Study ID Numbers: 12900, 5P30NR011403
Study First Received: September 6, 2011
Last Updated: May 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
cytokines
Guided imagery

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on April 16, 2014