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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04485728
Other study ID # IRB-2020-83
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 11, 2022
Est. completion date January 31, 2023

Study information

Verified date July 2023
Source Sam Houston State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 31, 2023
Est. primary completion date July 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients
Patients are getting sleep hygiene education and a sleep hygiene kit.

Locations

Country Name City State
United States Memorial Hermann Texas Medical Center Houston Texas

Sponsors (3)

Lead Sponsor Collaborator
Sam Houston State University Memorial Hermann Texas Medical Center, The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

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