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

Primary Purpose

High Risk Pregnancy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relaxation Intervention
Sponsored by
Towson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for High Risk Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pregnant women on bed rest for high risk pregnancy

Exclusion Criteria:

  • none

Sites / Locations

  • Towson University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Relaxation Intervention

Arm Description

Women hospitalized on bed-rest for high risk pregnancy participated in Relaxation Interventions.

Outcomes

Primary Outcome Measures

Interview
Participants participated in a follow up interview

Secondary Outcome Measures

Post-survey
Participants completed a brief post-survey

Full Information

First Posted
December 1, 2017
Last Updated
January 25, 2018
Sponsor
Towson University
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1. Study Identification

Unique Protocol Identification Number
NCT03419065
Brief Title
Relaxation Interventions for Pre-term Mothers on Hospitalized Bed-Rest
Official Title
Relaxation Interventions for Pre-term Mothers on Hospitalized Bed-Rest
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2012 (Actual)
Primary Completion Date
June 1, 2013 (Actual)
Study Completion Date
June 1, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Towson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the effects of participation in relaxation exercises on pregnant women who are hospitalized on bed-rest.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Risk Pregnancy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Relaxation Intervention
Arm Type
Other
Arm Description
Women hospitalized on bed-rest for high risk pregnancy participated in Relaxation Interventions.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Intervention
Intervention Description
Relaxing Music combined with Progressive Muscle relaxation and guided imagery
Primary Outcome Measure Information:
Title
Interview
Description
Participants participated in a follow up interview
Time Frame
5-7 days
Secondary Outcome Measure Information:
Title
Post-survey
Description
Participants completed a brief post-survey
Time Frame
5-7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant women on bed rest for high risk pregnancy Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenna Yeager, PhD, OTR/L
Organizational Affiliation
Towson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Towson University
City
Towson
State/Province
Maryland
ZIP/Postal Code
21234
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
de-identified data may be shared through publication but no identifying information will be shared

Learn more about this trial

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

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