- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02636374
Guided Imagery: Reducing Stress and Improving Well-being in Pregnant Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pregnant adolescents attending a local alternative education program will be subjects of this study. Students will participate in four, 15 minute guided imagery sessions over about a 4-6 week period. They will complete a pregnancy specific stress questionnaire before beginning and after completion of the guided imagery protocol. The students will also complete a short 9-question stress measure before and after each of the individual guided imagery sessions.
The specific aims are:
- to evaluate whether a guided imagery intervention reduces perceived stress in pregnant adolescents; and
- to evaluate whether a guided imagery intervention enhances well-being in pregnant adolescents.
The hypotheses are that the intervention will reduce perceived stress and enhance well-being in these subjects. The purpose of this study is to assess whether employing a guided imagery intervention with pregnant teens and education will reduce perceived stress levels and improve well-being.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All pregnant students ages 13-21 enrolled in the alternative education program for parenting teens were eligible to participate
Exclusion Criteria:
- Participants were excluded from the study if they delivered their babies prior to completing four sessions of guided imagery intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Guided Imagery
Participants listened to a pregnancy-specific guided imagery recording on four separate occasions during their pregnancies.
Perceived stress was measured immediately pre and post each listening session using the Perceived Stress Measure-9 (PSM-9).
|
A fifteen minute recording of gentle music together with soft talking to guide relaxation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Psychological Stress Measure-9 (PSM-9) score
Time Frame: 4 weeks
|
Participants will complete the PSM-9 before and after listening to guided imagery sessions for each of the 4 weekly intervention sessions.
The Psychological Stress Measure-9 (PSM-9) is a 9 item questionnaire measuring stress.
The original form was published in Canada by Louise Lemyre, PHD and Rejean Tessier, PHD in 1988 and the 9 item was published in 2002.
Each response rests on an 8 point likert scale.
For general surveys of health and well-being in the workplace, an abridged 9-item version was developed to meet a variety of research needs and applications.
The PSM-9 version is used at Hydro-Quebec and Renault (France) as well as in public service, hospitals, community services, and private practice.
It has the same psychometric qualities of reliability, validity, and internal consistency (.89) and maintains the same heuristic value for statistics: normality of distribution and responsiveness (Lemyre, Chair, & Lalande-Markon, 2009).
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Karla Ausderau, PhD, OTR/L, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-0105
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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