Sleep Improvement Intervention for Hospitalized Antepartum Patients

NCT ID: NCT04485728

Last Updated: 2023-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-11

Study Completion Date

2023-01-31

Brief Summary

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This project seeks to further study the effects of a hospital-based protocol for improving sleep in high-risk antepartum patients as piloted by Lee and Gay (2017).

Detailed Description

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Conditions

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Sleep Disturbance in Hospitalized Antepartum Patients

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sleep Improvement Intervention

Group Type EXPERIMENTAL

Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients

Intervention Type BEHAVIORAL

Patients are getting sleep hygiene education and a sleep hygiene kit.

Standard of Care (Control)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients

Patients are getting sleep hygiene education and a sleep hygiene kit.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* speak, read, and write English
* medically stable
* 20 weeks' gestation or greater
* viable fetus
* hospitalized at least 24 hours

Exclusion Criteria

* Do not speak, read, and write English
* Medically unstable
* Less than 20 weeks' gestation
* Nonviable fetus
* Hospitalized less than 24 hours
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role collaborator

Memorial Hermann Texas Medical Center

UNKNOWN

Sponsor Role collaborator

Sam Houston State University

OTHER

Sponsor Role lead

Responsible Party

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Andrea Smith

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea M Smith, Ph.D., RN

Role: PRINCIPAL_INVESTIGATOR

Sam Houston State University

Locations

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Memorial Hermann Texas Medical Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-2020-83

Identifier Type: -

Identifier Source: org_study_id

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