NCT04485728

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
1.6 years until next milestone

Study Start

First participant enrolled

March 11, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

August 2, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

July 21, 2020

Last Update Submit

July 31, 2023

Conditions

Sleep Disturbance in Hospitalized Antepartum Patients

Outcome Measures

Primary Outcomes (2)

  • Number of patients who use the sleep improvement intervention

    Day 7

  • 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

Study Arms (2)

Sleep Improvement Intervention

EXPERIMENTAL
Behavioral: Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients

Standard of Care (Control)

NO INTERVENTION

Interventions

Sleep Improvement Protocol Intervention for Hospitalized Antepartum PatientsBEHAVIORAL

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

Sleep Improvement Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States

Location

Study Officials

  • Andrea M Smith, Ph.D., RN

    Sam Houston State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 21, 2020

First Posted

July 24, 2020

Study Start

March 11, 2022

Primary Completion

July 31, 2022

Study Completion

January 31, 2023

Last Updated

August 2, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)