Effectiveness of an interactive music tablet intervention to reduce procedural anxiety in children: a randomized controlled trial.

Procedural anxiety in children is common and associated with maladaptive behavior, reduced cooperation, and increased perioperative stress. Although music-based interventions show promise, few are designed for routine clinical care. We evaluated an interactive tablet-based music intervention ("MuMa") for reducing procedural anxiety in children aged 3-11 undergoing elective surgery. We conducted a single-center, parallel-group, randomized controlled trial including 80 children undergoing elective surgery and their caregivers. Participants were randomized to receive the MuMa intervention preoperatively or standard care. Primary outcomes were child (modified Yale Preoperative Anxiety Scale) and caregiver anxiety (State-Trait Anxiety Inventory), assessed before and after the intervention. Secondary outcomes included heart rate variability, compliance during anesthesia induction, postoperative agitation, and behavioral changes at 1, 4, and 12 weeks post-procedure. Trial registration: German Clinical Trials Registry (DRKS00027873), registered 13 May 2022. Here we show that the intervention reduces preoperative anxiety by 38% (standardized mean difference -0.8; 95% CI -1.2 to -0.3) and integrates readily into routine perioperative workflows. Effects are greatest in children with high baseline anxiety (SMD -1.7; 95% CI -2.8 to -0.5) and in those aged 3-6 years (SMD -0.9; 95% CI -1.5 to -0.3). No clinically relevant differences are observed for secondary outcomes. This interactive music intervention significantly reduces procedural anxiety in children, particularly among younger participants and those with high baseline anxiety. Its low resource requirements and ease of implementation support its potential as a scalable non-pharmacological strategy in pediatric perioperative care. Further research should evaluate its generalizability across diverse settings.