ABSTRACT
PURPOSE: Pain and anxiety-inducing interventions have a major impact on pediatric patients. Pain reduction by virtual reality (VR) during port and vein punctures is well studied. This study investigates peri-interventional reduction of pain, anxiety and distress using VR compared to the standard of care (SOC) in a pediatric oncology outpatient clinic. METHODS: In a randomized, controlled cross-over design, patients aged 6-18 years experience potentially painful interventions accompanied by VR. Observational instruments include NRS, FPS-r, BAADS, mYPAS-SF, PedsQL and SSKJ3-8R. All patients undergo two observations: SOC (A) and VR (B) in a randomized order. In addition, parents and staff are interviewed. Specific conditions for VR in an outpatient clinic setting derived from interprofessional focus group discussion are being explored. RESULTS: Between July 2021 and December 2022 57 eligible patients were included and randomized to the orders A/B (n = 28) and B/A (n = 29). Thirty-eight patients completed both observations. Characteristics in both groups did not differ significantly. More than half of the patients had no previous experience with VR, 5% decided to discontinue VR prematurely. Peri-interventional pain, anxiety and distress were significantly reduced by VR compared with SOC. 71% of patients and 76% of parents perceived punctures with VR to be more relaxed than previous ones. 95% of patients perceived fun with VR goggles. Detailed questionnaires on individual stress and anxiety were returned from 26 of 38 patients. Focus group discussion with staff yielded evidence for successful implementation of VR in an outpatient clinic. CONCLUSIONS: The present study shows that VR can be used for peri-interventional reduction of pain, anxiety, and distress in the special environment of a pediatric outpatient clinic. Specific conditions must be met for successful implementation. Further studies are needed to identify particularly susceptible patients and to illuminate alternatives for distraction that are feasible to implement with limited resources. TRIAL REGISTRATION NUMBER: (ClinicalTrials.gov ID): NCT06235723; 01/02/2024; retrospectively registered. This study adheres to the standard checklist of CONSORT guidelines.