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Comfort Intervention in PICU Children

RecruitingNAAges 5 Years - 10 YearsAllAnkara Yildirim Beyazıt University
NCT07441668 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Intervention Family-Centered Comfort
  • Standard Care (in control arm)
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Where

1 site
Ordu Universitesi Egitim ve Arastirma Hastanesi
Ordu, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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