Sleep After Pediatric Critical Illness

Sponsor

Oregon Health and Science University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05879640

Collaborator

(none)

Enrollment

Location

Arms

18.4

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pediatric Critical Illness Sleep Disturbance	Behavioral: Sleep education	N/A

Detailed Description

We 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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Before-afterBefore-after

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 18, 2022

Anticipated Primary Completion Date :

Aug 30, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Sleep Disturbances Scale for Children [1-month]
26-item parent report sleep measure

Secondary Outcome Measures

Pediatric Quality of Life Inventory Scale (PedsQL) [1-month]
Parent rated quality of life measure, age based

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health & Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

Oregon Health and Science University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cydni Williams, Associate Professor, Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT05879640

Other Study ID Numbers:

23234

First Posted:

May 30, 2023

Last Update Posted:

May 30, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dyssomnias

Parasomnias

Critical Illness

Study Results

No Results Posted as of May 30, 2023