PINS: VIRTUAL REALITY (VR) COMPARED TO PASSIVE DISTRACTION FOR PAIN AND ANXIETY MANAGEMENT DURING ORTHOPAEDIC PROCEDURES IN CHILDREN. A MULTICENTRE PRAGMATIC RANDOMIZED CLINICAL TRIAL

Orthopaedic procedures such as percutaneous pins or sutures removal represent a potential source of pain and anxiety for the paediatric patients, as well as a source of anxiety for parents and caregivers. Pain and anxiety contribute to children and families negative trauma experience with possible long-term sequelae. The aim of this trial was to examine the effect of VR distraction compared to passive distraction for pain and anxiety relief during percutaneous pins removal and/or removal of sutures in paediatric orthopaedic clinics. It was a multicenter pragmatic randomized controlled trial (RCT) using a parallel design with two groups: 1) immersive VR and 2) control - non-immersive video game on tablet in an equal ratio of participants per group. Pain and anxiety were assessed immediately before (T0) and after (T1) the procedure, as well as one week after (T2) (memory of pain) using the Numerical Rating Scale (NRS) and the Child Fear Scale (CFS) respectively. Satisfaction scale (0-10) was used for parents and children and a satisfaction survey was delivered to caregivers after the procedure. Analyses were carried out according to the intention-to-treat principle, with a significance level (α) of 0.025, considering Bonferroni's correction. Subgroups analyses were planned for age and sex. One hundred eighty-eight participants aged from six to 17 years with a mean age of 10.8 ± 3.3 years were recruited from three tertiary centers. No statistically significant differences between the two groups were observed for pain and anxiety scores at T0, T1 and T2. However, a significant difference was observed on anxiety at T1 in favor of teenage boys over 12 years in the VR group (p=0.025). Statistically higher level of satisfaction with the use of VR was reported by parents (p=0.015) and caregivers (p=0.009) with 100% of caregivers recommending immersive VR for future non-invasive paediatric orthopaedic procedures. Procedural time was comparable for the two interventions (p=0.10). This large multicenter RCT showed no statistically significant differences in reduction of pain and anxiety in children using immersive VR compared to non-immersive video game during percutaneous pins removal and/or removal of sutures in orthopaedic clinics. However, VR was efficacious in reducing anxiety in teenage boys. Parents and caregivers were highly satisfied with the use of VR during the procedure. Even if VR is probably not the only answer for reducing pain and anxiety levels, it is part of the tools available at relatively low costs for children undergoing painful and stressful procedures in paediatric orthopaedic clinics.