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

High Risk Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419065
• Other study ID #: 09-A052R3
• Status: Completed
• Phase: N/A
• First received: December 1, 2017
• Last updated: January 25, 2018
• Start date: January 1, 2012
• Est. completion date: June 1, 2013

Study information

• Verified date: January 2018
• Source: Towson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 1, 2013
• Est. primary completion date: June 1, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women on bed rest for high risk pregnancy

Exclusion Criteria:

Related Conditions & MeSH terms

• High Risk Pregnancy

Intervention

Behavioral:
• Relaxation Intervention
Relaxing Music combined with Progressive Muscle relaxation and guided imagery

Locations

Country	Name	City	State
United States	Towson University	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Towson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interview	Participants participated in a follow up interview	5-7 days
Secondary	Post-survey	Participants completed a brief post-survey	5-7 days