Back to resultsSleep Improvement Intervention for Hospitalized Antepartum Patients
Primary Purpose
Sleep Disturbance in Hospitalized Antepartum Patients
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Disturbance in Hospitalized Antepartum Patients
Eligibility Criteria
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
Sites / Locations
- Memorial Hermann Texas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sleep Improvement Intervention
Standard of Care (Control)
Arm Description
Outcomes
Primary Outcome Measures
Number of patients who use the sleep improvement intervention
Level of satisfaction with the intervention as assessed by a Likert assessment
The scale ranges from 0-5 with 5 being extremely satisfied
Secondary Outcome Measures
Full Information
NCT ID
NCT04485728
First Posted
July 21, 2020
Last Updated
July 31, 2023
Sponsor
Sam Houston State University
Collaborators
The University of Texas Health Science Center, Houston, Memorial Hermann Texas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04485728
Brief Title
Sleep Improvement Intervention for Hospitalized Antepartum Patients
Official Title
Sleep Improvement Intervention for Hospitalized Antepartum Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 11, 2022 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sam Houston State University
Collaborators
The University of Texas Health Science Center, Houston, Memorial Hermann Texas Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance in Hospitalized Antepartum Patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sleep Improvement Intervention
Arm Type
Experimental
Arm Title
Standard of Care (Control)
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients
Intervention Description
Patients are getting sleep hygiene education and a sleep hygiene kit.
Primary Outcome Measure Information:
Title
Number of patients who use the sleep improvement intervention
Time Frame
Day 7
Title
Level of satisfaction with the intervention as assessed by a Likert assessment
Description
The scale ranges from 0-5 with 5 being extremely satisfied
Time Frame
Day 7
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea M Smith, Ph.D., RN
Organizational Affiliation
Sam Houston State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Hermann Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sleep Improvement Intervention for Hospitalized Antepartum Patients
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