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NCT05879640 Clinical Trial

Sleep After Pediatric Critical Illness

Critical Illness Clinical Trial

Official title:
Sleep Disturbances for Children After Critical Care: Pilot Sleep Education Intervention

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05879640
Other study ID # 23234
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 18, 2022
Est. completion date December 31, 2023

Study information
Verified date April 2024
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study tests a pilot educational sleep intervention for children after critical care hospitalization.

Description:

The investigators are conducting a before-after study evaluating an educational intervention delivered during hospitalization on sleep outcomes 1month after critical care hospitalization for children aged 6 to 18 years.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date December 31, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria: - Age 6 years to 18 years inclusive - Inpatient consult to Pediatric Critical Care and Neurotrauma Recovery Program Exclusion Criteria: - Abusive trauma - Child protective services custody - Prisoners - Pregnancy - Non-English speaking caregivers

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Sleep education
Participants receive a handout about age appropriate sleep goals and tips for improving sleep. The handout also contains links to educational videos about sleep hygiene and the importance of sleep to healing after illness. The handout is reviewed with a clinician at bedside prior to hospital discharge.

Locations
Country Name City State
United States Oregon Health & Science University Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sleep Disturbances Scale for Children 26-item parent report sleep measure; generates total T-score and 6 subscale T-scores (range 0-100, M 50, SD 10) 1-month
Secondary Pediatric Quality of Life Inventory Scale (PedsQL) Parent rated quality of life measure, age based; Generates total score 0-100 1-month
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