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

Not Applicable

Completed

• Conditions: High Risk Pregnancy
• Interventions: Behavioral: Relaxation Intervention

• Registration Number: NCT03419065
• Lead Sponsor: Towson University

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.

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2013-06-01
• Study Completion: 2013-06-01
• Study First Submitted: 2017-12-01
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-25
• Last Update Submitted: 2018-01-25
• Study First Posted: 2018-02-01
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• Pregnant women on bed rest for high risk pregnancy

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Interview	5-7 days	Participants participated in a follow up interview

Secondary Outcome Measures

Name	Time	Method
Post-survey	5-7 days	Participants completed a brief post-survey

Trial Locations

Locations (1)

Towson University; 🇺🇸 Towson, Maryland, United States