Sleep After Pediatric Critical Illness

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

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

Study Overview

• Status: Completed
• Conditions: Critical Illness; Sleep Disturbance; Pediatric
• Intervention / Treatment: Behavioral: Sleep education

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Before- standard care
Other: After- intervention; Patients studied in this arm receive the new educational intervention delivered in conjunction with standard care	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Quality of Life Inventory Scale (PedsQL)	Parent rated quality of life measure, age based; Generates total score 0-100	1-month

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Cydni Williams, MD, MCR, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: May 18, 2023
• First Submitted That Met QC Criteria: May 18, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Wake Disorders; Disease Attributes; Dyssomnias; Parasomnias; Critical Illness
• Other Study ID Numbers: 23234

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