Augmented reality and pain during botulinum neurotoxin A injections in children with cerebral palsy: A randomized controlled trial

AIM: To assess the effect of the augmented reality application called Minidocs on pain reduction during botulinum neurotoxin A (BoNT-A) injections in children with cerebral palsy (CP). METHOD: Children with CP aged 3 to 8 years undergoing BoNT-A injection were randomized to usual pain management alone (n = 41) or combined with Minidocs (n = 39). Minidocs is an augmented reality application on a digital device offering several games including active distraction, hypnotic suggestion, and counter-aggression features. The primary outcome was the child's pain during BoNT-A injection, combining patient-reported (Faces Pain Scale [FPS]) and observer-reported (Face, Legs, Activity, Cry, Consolability scale [FLACC]) outcomes. Secondary outcomes included anxiety of children (Modified Yale Preoperative Anxiety Scale) and parents (State-Trait Anxiety Inventory Form Y-1), and satisfaction with Minidocs. RESULTS: In total, 14 out of 41 (34.1%) children in the control group and 7 out of 39 (17.9%) children in the experimental group experienced pain (i.e. FPS or FLACC scores ≥4). The difference between groups was not statistically significant (odds ratio 0.36; 95% confidence interval 0.11-1.16; p = 0.087). Changes in anxiety scores from before to after injection did not differ between groups. Satisfaction with the use of Minidocs was high. INTERPRETATION: This study did not demonstrate the benefit of augmented reality on pain reduction. The counter-aggression feature is an innovation of Minidocs worth exploring. Further studies are needed to identify profiles of children who respond to non-drug therapies.