NCT03419065

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

1.4 years

First QC Date

December 1, 2017

Last Update Submit

January 25, 2018

Conditions

High Risk Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Interview

    Participants participated in a follow up interview

    5-7 days

Secondary Outcomes (1)

  • Post-survey

    5-7 days

Study Arms (1)

Relaxation Intervention

OTHER

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

Behavioral: Relaxation Intervention

Interventions

Relaxation InterventionBEHAVIORAL

Relaxing Music combined with Progressive Muscle relaxation and guided imagery

Relaxation Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women on bed rest for high risk pregnancy

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Towson University

Towson, Maryland, 21234, United States

Location

Study Officials

  • Jenna Yeager, PhD, OTR/L

    Towson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2017

First Posted

February 1, 2018

Study Start

January 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

February 1, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

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

Locations

US(1)