Comfort Intervention in PICU Children
Recruiting · NCT07441668 · Interventional (participants receive a specific treatment) · Lead sponsor: Ankara Yildirim Beyazıt University
View the official record on ClinicalTrials.gov →Interventions studied
Intervention Family-Centered ComfortStandard Care (in control arm)
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.
Who can take part
Age range
5 Years to 10 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Ordu Universitesi Egitim ve Arastirma Hastanesi - Ordu, Altınordu, Turkey (Türkiye)