- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04485728
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
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
-
-
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
|
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
Collaborators
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.
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