Sleep Improvement Intervention for Hospitalized Antepartum Patients

July 31, 2023 updated by: Andrea Smith, Sam Houston State University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Memorial Hermann Texas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sleep Improvement Intervention
Behavioral: Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients
Patients are getting sleep hygiene education and a sleep hygiene kit.
No Intervention: Standard of Care (Control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who use the sleep improvement intervention
Time Frame: Day 7
Day 7
Level of satisfaction with the intervention as assessed by a Likert assessment
Time Frame: Day 7
The scale ranges from 0-5 with 5 being extremely satisfied
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sam Houston State University

Collaborators

The University of Texas Health Science Center, Houston
Memorial Hermann Texas Medical Center

Investigators

  • Principal Investigator: Andrea M Smith, Ph.D., RN, Sam Houston State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2022

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

July 21, 2020

First Submitted That Met QC Criteria

July 21, 2020

First Posted (Actual)

July 24, 2020

Study Record Updates

Last Update Posted (Actual)

August 2, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-2020-83

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Disturbance in Hospitalized Antepartum Patients

Clinical Trials on Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe