Pediatric Intensive Care UnitComfortAnxiety in ChildrenFearSleep
Investigational drug(s) / intervention(s)
Intervention Family-Centered ComfortStandard Care (in control arm)
Intervention Family-Centered Comfort: Storytelling with the mother's voice, dimmed lighting, and weighted blanket administered by the researcher to children in the intervention group.
Standard Care (in control arm): Routine care provided to children in the control group without additional comfort interventions.
Study summary
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.
Eligibility
Sex
ALL
Min age
5 Years
Max age
10 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
COMFORT-B Behavioral Comfort Scale Total Score (6-30) — Baseline; 24 hours after admission; 12 hours after intervention Behavioral comfort assessed using the COMFORT-B Behavioral Comfort Scale. Six items scored from 1 to 5. Total score ranges from 6 to 30. Higher scores indicate lower comfort.
Trial sites (1)
Facility
City
Region
Status
Ordu Universitesi Egitim ve Arastirma Hastanesi
Ordu
Altınordu
Recruiting
More Ankara Yildirim Beyazıt University trials in Turkey
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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