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The Effect of a Kolcaba Comfort Theory-Based Child Comfort Intervention on Comfort, Anxiety, Fear, and Sleep in the Pediatric Intensive Care Unit: A Randomized Controlled Trial
Led by Ankara Yildirim Beyazıt University · Updated on 2026-05-12
86
Participants Needed
1
Research Sites
58 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating a family-centered comfort intervention for children aged 5 to 10 years who are hospitalized in a pediatric intensive care unit (PICU). This randomized controlled trial aims to determine if adding this intervention to routine nursing care can improve child comfort, reduce anxiety and fear, and enhance sleep, while also decreasing parental anxiety and increasing satisfaction with care. Children in the intervention group will receive a comfort approach that includes listening to their mother's voice through storytelling, dimmed environmental lighting, and the use of a weighted blanket alongside standard care. The control group will receive only routine nursing care without these additional comfort measures. Assessments will be made at baseline, 24 hours after admission, and 12 hours after completing the intervention. Participants and their parents will be involved in comfort, anxiety, fear, and sleep evaluations using various scales and wrist actigraphy to monitor sleep patterns. Parental state anxiety and satisfaction with care will also be assessed. The primary outcome is the child's behavioral comfort score measured at specified intervals. The study continues until 12 hours after the intervention, with all assessments closely monitored to evaluate the impact of the comfort intervention compared to standard care.
CONDITIONS
Brief Title
Comfort Intervention in PICU Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child aged 5 to 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 to 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 or 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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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 48 to 72 hours or duration of PICU stay
Participants receive either the family-centered comfort intervention including storytelling with the mother's voice, dimmed lighting, and weighted blanket, or standard routine care while in the Pediatric Intensive Care Unit (PICU).
Assessments at baseline, 24 hours after admission, and 12 hours after intervention
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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