Actively Recruiting
Comfort Intervention in PICU Children
Led by Ankara Yildirim Beyazıt University · Updated on 2026-05-12
86
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comfort Intervention in PICU Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ordu Universitesi Egitim ve Arastirma Hastanesi
Ordu, Altınordu, Turkey (Türkiye), 52200
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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