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

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.

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.

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