Effectiveness of Guided Imagery Intervention on Factors Associated With Maternal Stress and Preterm Birth
Condition: Preterm Birth; Maternal Stress
MeSH terms: Premature Birth
Study type: Interventional

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.
    

Intervention name(s): Guided Imagery
Intervention type(s): Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: cytokines; Guided imagery