| NCT ID | NCT07441668 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ankara Yildirim Beyazıt University |
| Condition | Pediatric Intensive Care Unit |
| Study Type | INTERVENTIONAL |
| Enrollment | 86 participants |
| Start Date | 2026-02-20 |
| Primary Completion | 2026-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 86 participants in total. It began in 2026-02-20 with a primary completion date of 2026-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Frequently Asked Questions
Who can join the NCT07441668 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 10 Years, studying Pediatric Intensive Care Unit. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07441668 currently recruiting?
Yes, NCT07441668 is actively recruiting participants. Visit ClinicalTrials.gov or contact Ankara Yildirim Beyazıt University to inquire about joining.
Where is the NCT07441668 trial being conducted?
This trial is being conducted at Ordu, Turkey (Türkiye).
Who is sponsoring the NCT07441668 clinical trial?
NCT07441668 is sponsored by Ankara Yildirim Beyazıt University. The trial plans to enroll 86 participants.