RecruitingNot ApplicableNCT07441668

Comfort Intervention in PICU Children

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

Sponsor

Ankara Yildirim Beyazıt University

Enrollment

86 participants

Start Date

Feb 20, 2026

Study Type

INTERVENTIONAL

Conditions

Anxiety in children Sleep Fear Comfort Pediatric Intensive Care Unit

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

Min Age: 5 YearsMax Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Intervention Family-Centered Comfort and Standard Care (in control arm) for people with anxiety in children, comfort, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 5 Years to 10 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALIntervention Family-Centered Comfort

Storytelling with the mother's voice, dimmed lighting, and weighted blanket administered by the researcher to children in the intervention group.

OTHERStandard Care (in control arm)

Routine care provided to children in the control group without additional comfort interventions.

Locations(1)

Ordu Universitesi Egitim ve Arastirma Hastanesi

Ordu, Altınordu, Turkey (Türkiye)

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NCT07441668

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