NCT02636374

Brief Summary

The purpose of this study is to examine the effects of a guided imagery intervention on perceived stress in pregnant adolescents.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 21, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

6 years

First QC Date

December 1, 2015

Last Update Submit

November 2, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Psychological Stress Measure-9 (PSM-9) score

    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

Study Arms (1)

Guided Imagery

EXPERIMENTAL

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).

Behavioral: Guided Imagery

Interventions

Guided ImageryBEHAVIORAL

A fifteen minute recording of gentle music together with soft talking to guide relaxation.

Guided Imagery

Eligibility Criteria

Age13 Years - 21 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All pregnant students ages 13-21 enrolled in the alternative education program for parenting teens were eligible to participate

You may not qualify if:

  • Participants were excluded from the study if they delivered their babies prior to completing four sessions of guided imagery intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stress, Psychological

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Karla Ausderau, PhD, OTR/L

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2015

First Posted

December 21, 2015

Study Start

November 1, 2012

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

November 6, 2018

Record last verified: 2018-11