Relaxation Interventions for Pre-term Mothers on Hospital... | NCT03419065

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

NCT03419065

Sponsor

Towson University

Status

Completed

Last Update Posted

Feb 1, 2018Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

High Risk Pregnancy

Interventions

Relaxation Intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2012Actual

Primary Completion Date

Jun 1, 2013Actual

Completion Date

Jun 1, 2013Actual

First Submitted Date

Dec 1, 2017

First Submission Date that Met QC Criteria

Jan 25, 2018

First Posted Date

Feb 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2018

Last Update Posted Date

Feb 1, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Relaxation Intervention	Other	Women hospitalized on bed-rest for high risk pregnancy participated in Relaxation Interventions.	Behavioral: Relaxation Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Relaxation Intervention	Behavioral	Relaxing Music combined with Progressive Muscle relaxation and guided imagery	Relaxation Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Interview	Participants participated in a follow up interview	5-7 days

Secondary Outcomes

Measure	Description	Time Frame
Post-survey	Participants completed a brief post-survey	5-7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women on bed rest for high risk pregnancy

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jenna Yeager, PhD, OTR/L	Towson University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Towson University		Towson	Maryland	21234	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided