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Comfort Intervention in PICU Children

Study acronym: CCI-PICU
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Recruitment openedv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07441668
Lead Sponsor Ankara Yildirim Beyazıt University
Conditions
(from sponsor)		 Pediatric Intensive Care Unit, Comfort, Anxiety in Children, Fear, Sleep
Related terms Anxiety Disorders
Enrollment 86 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov