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

May 14, 2014 updated by: Virginia Commonwealth University

Guided Imagery Effects on Pregnancy Symptoms and Outcomes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
maternal stress (perceived stress)
Time Frame: baseline
baseline
maternal stress (perceived stress)
Time Frame: 8th Week
8th Week
maternal stress (perceived stress)
Time Frame: 12th Week
12th Week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
baseline
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
8th Week
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
12th Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Commonwealth University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nancy Jallo, PhD, VCU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12900
  • 5P30NR011403 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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