Relaxation Interventions for Pre-term Mothers on Hospitalized Bed-Rest

January 25, 2018 updated by: Towson University
The purpose of this study is to investigate the effects of participation in relaxation exercises on pregnant women who are hospitalized on bed-rest.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women, 18 or older, who consent to this study will participate in a preliminary interview. Study participants will then be trained in the use of progressive muscle relaxation and guided imagery for pregnancy. Participants will be issued a listening device and an audio file and asked to practice it on a daily basis while in the hospital.

Prior to discharge or delivery, the participant will be visited by a member of the research team who will conduct a follow-up interview. The interviews and the relaxation practice sessions will take between 30 and 45 minutes each. The interviews will be audio-recorded, although no identifying information about the participants will be recorded.

At the conclusion of the study, participants will be given a CD of the audio relaxation program and thanked for their participation in the study.

There is minimal risk anticipated in association with participation in this study. All information gained from this study will remain confidential and is for educational purposes only. Participants are entitled to terminate their participation in the study at any time.

It is hoped that the results of this study will provide information about an intervention that may be beneficial to women with high-risk pregnancies. It is also hoped that participation in the exercises will be enjoyable and/or beneficial to you in some way. The results of this study may be used to justify further studies or to influence the type of interventions offered in this or similar settings.

All data collected from the research will remain confidential. Data collected from participants will immediately be assigned an identification number so that no one will be able to identify any individuals in the study.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • 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
    • Maryland
      • Towson, Maryland, United States, 21234
        • Towson 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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women on bed rest for high risk pregnancy

Exclusion Criteria:

  • none

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: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Relaxation Intervention
Women hospitalized on bed-rest for high risk pregnancy participated in Relaxation Interventions.
Behavioral: Relaxation Intervention
Relaxing Music combined with Progressive Muscle relaxation and guided imagery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Interview
Time Frame: 5-7 days
Participants participated in a follow up interview
5-7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-survey
Time Frame: 5-7 days
Participants completed a brief post-survey
5-7 days

Collaborators and Investigators

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

Sponsor

Towson University

Investigators

  • Principal Investigator: Jenna Yeager, PhD, OTR/L, Towson University

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 (ACTUAL)

January 1, 2012

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

December 1, 2017

First Submitted That Met QC Criteria

January 25, 2018

First Posted (ACTUAL)

February 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2018

Last Update Submitted That Met QC Criteria

January 25, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-A052R3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

de-identified data may be shared through publication but no identifying information will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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