Clinical trial Recruiting at 1 site Interventional Ages 1 Year to 18

COPM-guided goal setting for children in the PICU

Official title: 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

Run by Samsung Medical Center · NCT07128446 · Data updated 2026-11-12

This will try using the COPM tool with therapists and caregivers to set personalized rehabilitation goals for children aged 1–18 who are admitted to the PICU.

Quick facts

Study typeInterventional
Ages1 Year to 18 Years
SexAll
Enrollment5 (estimated)
SponsorSamsung Medical Center
Academic / other
Locations2 sites (Seoul, Gangnam-gu and 1 other locations)
StatusRecruiting
StartedAugust 29, 2025
Main results expectedNovember 30, 2026
Study endsDecember 31, 2026
Registry record updatedMarch 10, 2026
Trial IDNCT07128446 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for the pilot phase are children aged 1–18 admitted to the PICU for at least 24 hours, their Korean-speaking legal guardians, and the treating PICU occupational or physical therapists.

Probably not a fit

Patients under age 1, those discharged before 24 hours, non-Korean-speaking families, or caregivers judged too distressed to participate are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The project uses a COPM (Canadian Occupational Performance Measure)-based approach to structure goal setting in the pediatric intensive care unit. Initial Delphi phases will enroll experienced pediatric rehabilitation clinicians to shape the strategy, followed by a pilot phase that tests the approach with caregivers of children (aged 1–18) and the treating PICU occupational or physical therapists. Interventions consist of standard physical and occupational therapy delivered alongside COPM-guided goal discussions. The work is being conducted at Samsung Medical Center in Seoul and requires Korean-language participation for surveys and caregiver engagement.

Why it matters

Potential benefit: If successful, this approach could produce clearer, family-centered rehabilitation goals that improve therapy focus and potentially speed functional recovery.

How similar studies have gone: The COPM is well established in pediatric rehabilitation settings, but its formal use specifically within the PICU is relatively novel with limited prior evidence.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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 Criteria:

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

Where it's running

  • Samsung Medical Center
    Seoul, Gangnam-gu, South Korea
    Recruiting
  • Samsung Medical Center
    Seoul, South Korea
    Not yet recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.