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Completed

NCT Number: NCT03419065

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

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

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Key information

Conditions

High Risk Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Towson University

Towson, Maryland, 21234, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant women on bed rest for high risk pregnancy

Exclusion criteria

  • none

Treatment and study plan

Relaxation Intervention

Behavioral

Relaxing Music combined with Progressive Muscle relaxation and guided imagery

Primary outcomes

  1. Interview

    Time frame: 5-7 days

    Participants participated in a follow up interview

Secondary outcomes

  1. Post-survey

    Time frame: 5-7 days

    Participants completed a brief post-survey

Sponsors and collaborators

Lead sponsor

Towson University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 1, 2018
Registry last updated
Feb 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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