Validity of the Children's Chelsea Critical Care Physical Assessment Tool (cCPAx-TR) in Turkish P… (NCT07241455) | Clinical Trial Compass
CompletedNot Applicable
Validity of the Children's Chelsea Critical Care Physical Assessment Tool (cCPAx-TR) in Turkish Pediatric Intensive Care Patients
Turkey (Türkiye)50 participantsStarted 2025-09-01
Plain-language summary
This single-center, prospective observational study aims to translate, culturally adapt, and evaluate the validity and reliability of the Children's Chelsea Critical Care Physical Assessment Tool (cCPAx) in Turkish pediatric intensive care settings (cCPAx-TR). We will assess content validity with an expert panel, feasibility in a pilot run, test-retest reliability, internal consistency, and criterion validity against established clinical scores.
Who can participate
Age range
2 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* Children aged 2 to 18 years
* Admitted to the pediatric intensive care unit (PICU)
* Clinically stable for bedside assessment
* Parental or guardian informed consent obtained (and child assent when appropriate)
* Able to perform or be observed for at least one item of the cCPAx-TR
* Exclusion Criteria
* Unstable hemodynamics or severe hypoxemia that prevents safe assessment
* Deep sedation or neuromuscular blockade that prevents observation at both assessments
* Severe orthopedic or neurological conditions (for example, unstable fractures or acute paralysis) that prohibit safe mobilization
* Expected death or withdrawal of care within 24 hours
* Refusal of consent by parents or guardians
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Test-retest intraclass correlation coefficient (ICC) - total cCPAx-TR score
Timeframe: two measurements conducted 48 hours apart