NCT07441668

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Ankara Yildirim Beyazıt University · Academic / Other
• Sex: All
• Age: 5 Years – 10 Years
• Healthy volunteers: Accepted

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.

Detailed description

This randomized controlled trial will be conducted in a PICU to evaluate the effectiveness of a family-centered comfort intervention based on Kolcaba's Comfort Theory. Eligible children and their parents will be enrolled after consent and randomly assigned to an intervention group or a control group. The control group will receive routine nursing care. The intervention group will receive routine care plus a multidimensional comfort intervention including maternal voice exposure, environmental light regulation, and a weighted blanket. Child outcomes will include comfort, anxiety, fear, and sleep parameters. Parent outcomes will include state anxiety and satisfaction with care. Assessments will be performed at baseline, 24 hours after admission, and 12 hours after completion of the intervention. The primary objective is to determine whether the intervention improves child comfort and related outcomes, and whether it positively affects parental anxiety and satisfaction compared with routine care.

Conditions

• Pediatric Intensive Care Unit
• Comfort
• Anxiety in Children
• Fear
• Sleep

Interventions

Type	Name	Description
BEHAVIORAL	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.
OTHER	Standard Care (in control arm)	Routine care provided to children in the control group without additional comfort interventions.

Timeline

• Start date: 2026-02-20
• Primary completion: 2026-05-15
• Completion: 2027-07-01
• First posted: 2026-03-02
• Last updated: 2026-03-02