Abstract
Chemotherapy administration in pediatric oncology patients frequently provokes acute procedural pain, anticipatory distress, and heightened anxiety, which can complicate clinical workflows and reduce treatment adherence. While non-pharmacological modalities such as conventional art therapy and immersive virtual reality (VR) distraction have individually shown promise, the integrative efficacy of active virtual reality art therapy remains underexplored. This single-center randomized controlled trial evaluated the effects of an immersive VR art therapy intervention on pain perception, state anxiety, and physiological stress markers in pediatric oncology patients undergoing active chemotherapy infusions. Eighty-four pediatric oncology patients aged 7 to 16 years were randomly allocated (1:1) to receive either a 30-minute immersive 3D digital art creation session during infusion (n = 42) or standard passive digital entertainment (n = 42). Primary outcomes included subjective pain intensity assessed via the Wong-Baker FACES Pain Rating Scale and state anxiety measured using the State-Trait Anxiety Inventory for Children (STAIC-S). Secondary outcomes comprised salivary cortisol concentrations and vital sign stability. The VR art therapy group demonstrated a statistically significant reduction in post-infusion pain scores (mean difference: -1.82, 95% CI [-2.34, -1.30], p < 0.001) and state anxiety scores (mean difference: -7.45, 95% CI [-9.80, -5.10], p < 0.001) compared with the control cohort. Salivary cortisol levels also decreased significantly in the intervention arm. These findings indicate that immersive virtual reality art therapy serves as an effective, safe, and engaging non-pharmacological adjunctive therapy to mitigate procedural pain and psychological distress in pediatric cancer patients.