The Effect of an Interactive Digital Art-Based Relaxation Program on Physiological Parameters, Anxiety, and Emotional Distress in Children Receiving Treatment in the Pediatric Intensive Care Unit: A Randomized Controlled Trial

Children hospitalized in pediatric intensive care units are exposed to multiple stressors, including invasive procedures, environmental noise, physical discomfort, and separation from family members. These factors may lead to increased anxiety, emotional distress, and physiological dysregulation, even in children who are conscious and not receiving sedation. There is a growing need for brief, feasible, and child-friendly non-pharmacological interventions that can be safely implemented in the PICU setting to support emotional well-being and physiological stability.

This study is designed as a parallel-group, randomized controlled trial to evaluate the effectiveness of an Interactive Digital Art-Based Relaxation Program in reducing anxiety and emotional distress and improving physiological parameters in children aged 7-12 years receiving care in a pediatric intensive care unit. The study will be conducted between February 2026 and March 2027 in the Pediatric Intensive Care Unit of Etlik City Hospital, Ministry of Health.

A total of 60 children who meet the inclusion criteria will be randomly assigned to either the intervention group (n = 30) or the control group (n = 30) using simple randomization. Randomization will be performed by an independent statistician using a computerized randomization tool. Eligible participants will be conscious, hemodynamically stable, not receiving continuous sedative or analgesic infusion, and able to follow verbal instructions.

Children in the intervention group will receive an Interactive Digital Art-Based Relaxation Program consisting of three sessions. Each session will last approximately 8-10 minutes and will be delivered via a tablet under nurse guidance. The program integrates interactive digital art activities with relaxation components designed to promote emotional expression, attention regulation, and calming responses. The control group will receive standard pediatric intensive care nursing care without additional psychosocial intervention.

Data will be collected at baseline and after completion of the intervention. Baseline assessments will include a descriptive characteristics form, physiological parameters (heart rate, respiratory rate, blood pressure, oxygen saturation, and pain), the State Anxiety Inventory for Children, and the Emotion Thermometer. Physiological parameters will also be recorded immediately before and after each intervention session. Post-intervention assessments will include repeated physiological measurements, the State Anxiety Inventory for Children, and the Emotion Thermometer.