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Comfort Intervention in PICU Children

Ordu, Altınordu · Ages 5–10 · Therapy / behavioral/Other · NCT07441668

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.

Inclusion Criteria

  • Child aged 5-10 years
  • Has not received intravenous sedation or anesthetic medication in the past 12 hours
  • Expected to stay in the Pediatric Intensive Care Unit (PICU) for at least 48-72 hours
  • Conscious and able to communicate
  • Glasgow Coma Scale score of 15
  • No pain as assessed by the Wong-Baker FACES Pain Rating Scale
  • Written informed consent obtained from parent/legal guardian
  • Child and parent able to communicate in Turkish
  • No medical contraindications to non-pharmacological, non-interactive interventions

Exclusion Criteria

  • Mechanically ventilated or intubated
  • Hearing impairment
  • Visual impairment
  • Hand motor limitations
  • Severe or profound intellectual disability
  • Epilepsy or history of seizures
  • Severe underweight
  • Chronic respiratory disease
  • Chronic cardiovascular disease
  • Surgical implants
  • Osteoporosis
  • Diagnosis of sleep disorder
  • Use of sleep medication
  • Any physical or mental health condition that prevents communication

View official listing on ClinicalTrials.gov ↗

This page is for general information only and is not a guarantee of eligibility or enrollment. Trial details are subject to change — the study site will confirm final eligibility criteria.