RecruitingNot ApplicableNCT07128446

COPM-Based Goal Setting Strategies in the PICU

Development and Feasibility Evaluation of Canadian Occupational Performance Measure-Based Goal Setting Strategies for Pediatric Intensive Care Unit Patients: A Multi-Phase Mixed-Methods Study

Sponsor

Samsung Medical Center

Enrollment

5 participants

Start Date

Aug 29, 2025

Study Type

INTERVENTIONAL

Conditions

Critical Illness Pediatric Intensive Care Unit

Summary

COPM-Based Goal Setting Strategies in the PICU

Eligibility

Min Age: 1 YearMax Age: 18 Years

Inclusion Criteria9

Phase 1-2 (Delphi Survey - Experts)
Physicians specializing in pediatrics or physical medicine and rehabilitation, occupational therapists, physical therapists, and nursing staff
Minimum of 2 years of direct clinical experience in a Pediatric Intensive Care Unit (PICU)
Phase 3 (Pilot Testing - Caregivers \& PICU Clinicians)
Caregivers:
Legal guardian of a child aged 1-18 years admitted to PICU
≥24 hours post-admission
PICU clinicians:
\- Treating occupational or physical therapist involved in the child's care during PICU admission

Exclusion Criteria7

Phase 1-2 (Delphi Survey - Experts)
Rehabilitation professionals without prior PICU clinical experience
Inability to read or respond to Korean-language surveys
Phase 3 (Pilot Testing - Caregivers \& PICU Clinicians)
Caregivers experiencing severe emotional distress, or deemed inappropriate for participation by the treating clinician
Non-Korean-speaking caregivers
Refusal or withdrawal of informed consent at any stage

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Interventions

OTHERStandard physical and occupational therapy

Participants admitted to the Pediatric Intensive Care Unit (PICU) will receive standard occupational therapy as part of routine clinical care. Interventions will be tailored to each patient's medical status and functional needs and may include activities of daily living (ADL) training, positioning, range of motion exercises, sensory stimulation, and caregiver education. No additional experimental treatment will be introduced for study purposes. The primary focus of the study is to evaluate patient-centered outcomes using the Canadian Occupational Performance Measure (COPM), without altering the standard therapeutic approach.