NCT01436786

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

May 16, 2014

Status Verified

May 1, 2014

Enrollment Period

2.2 years

First QC Date

September 6, 2011

Last Update Submit

May 14, 2014

Conditions

Preterm BirthMaternal Stress

Keywords

cytokinesGuided imagery

Outcome Measures

Primary Outcomes (3)

  • maternal stress (perceived stress)

    baseline

  • maternal stress (perceived stress)

    8th Week

  • maternal stress (perceived stress)

    12th Week

Secondary Outcomes (3)

  • neuroendocrine (CRH) and immunological mediators (IL-1β, IL-6, Il-8, IL-10, IL-12, TNF-α, IFN-γ, G-CSF, GM-CSF)

    baseline

  • neuroendocrine (CRH) and immunological mediators (IL-1β, IL-6, Il-8, IL-10, IL-12, TNF-α, IFN-γ, G-CSF, GM-CSF)

    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)

    12th Week

Study Arms (2)

Guided Imagery Intervention

EXPERIMENTAL

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

Control group

NO INTERVENTION

continues usual plan of care

Interventions

Guided ImageryOTHER

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.

Guided Imagery Intervention

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being pregnant between 14-17 weeks gestation
  • Being African American
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Nancy Jallo, PhD

    VCU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2011

First Posted

September 20, 2011

Study Start

June 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

May 16, 2014

Record last verified: 2014-05

Locations

US(1)