Family-centered comfort support for children in the pediatric ICU
Official title: 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
Run by Ankara Yildirim Beyazıt University · NCT07441668 · Data updated 2026-11-12
This program will try a family-centered comfort package—recorded maternal voice, dimmed lighting, and a weighted blanket—for 5–10-year-old PICU patients to see if it improves their comfort, reduces anxiety and fear, helps sleep, and lowers parents' anxiety.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 5 Years to 10 Years |
| Sex | All |
| Enrollment | 86 (estimated) |
| Sponsor | Ankara Yildirim Beyazıt University Academic / other |
| Locations | 1 site (Ordu, Altınordu) |
| Status | Recruiting |
| Started | February 20, 2026 |
| Main results expected | May 15, 2026 |
| Study ends | July 1, 2027 |
| Registry record updated | May 12, 2026 |
| Trial ID | NCT07441668 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are conscious, communicative children aged 5–10 who speak Turkish, have a Glasgow Coma Scale of 15, have not received IV sedation in the past 12 hours, are expected to remain in the PICU for 48–72 hours, and have parental consent.
✕Probably not a fit
Children who are mechanically ventilated or intubated, sedated, have hearing or vision impairments, severe intellectual disability, epilepsy/seizure history, or other contraindications to non‑interactive interventions are unlikely to benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial in a pediatric intensive care unit will enroll conscious, communicative children aged 5–10 and randomly assign them to routine nursing care or routine care plus a multidimensional comfort intervention. The intervention combines maternal voice exposure, environmental light regulation, and a weighted blanket delivered alongside usual care. Outcomes include child comfort, anxiety, fear, and sleep parameters, plus parental state anxiety and satisfaction with care, measured at baseline, 24 hours after admission, and 12 hours after the intervention. The primary aim is to see whether the family-centered intervention yields better child and parent outcomes than routine care alone.
Why it matters
Potential benefit: If successful, the intervention could reduce child anxiety and fear, improve comfort and sleep during PICU stays, and decrease parental anxiety while increasing satisfaction with care.
How similar studies have gone: Small pediatric and component-specific studies (maternal voice, light control, weighted blankets) have reported benefits for comfort, anxiety, or sleep, but combined family-centered interventions in the PICU are relatively novel with limited prior evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
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Ordu Universitesi Egitim ve Arastirma Hastanesi
Ordu, Altınordu, Turkey (Türkiye) Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.