Clinical Trial

Comfort Intervention in PICU Children

Study acronym: CCI-PICU
Recruiting
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Record status
This record was last updated May 12, 2026 (before its estimated May 15, 2026 completion). Its status may not reflect the trial's current state.
Summary
This randomized controlled trial evaluates a family-centered comfort intervention for children hospitalized in a pediatric intensive care unit. The intervention consists of listening to the mother's voice, environmental light regulation, and use of a weighted blanket, delivered in addition to routine nursing care. Outcomes include child comfort, anxiety, fear, and sleep parameters, as well as parental anxiety and satisfaction with care. The study will determine whether the intervention improves child and parent outcomes compared with routine care.
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-13
Trial Details
NCT Number NCT07441668
Lead Sponsor Ankara Yildirim Beyazıt University
Conditions Pediatric Intensive Care Unit, Comfort, Anxiety in Children, Fear, Sleep
Enrollment 86 participants
Start Date 2026-02-20
Primary Completion 2026-05-15 (estimated)
Study Completion 2027-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-12