Virtual reality for pain control during shock wave lithotripsy: a randomized controlled study

Abstract

Purpose: Although external shock wave lithotripsy (SWL) is an outpatient procedure generally not requiring anesthesia or sedation, patients may experience pain during the procedure. The aim of this study is to evaluate whether a virtual reality device is effective in reducing patient-reported pain during the procedure, consequently leading to exposure to higher energy levels and better clinical outcomes.

Methods: Inclusion criteria for SWL were according to the latest EAU guidelines on urolithiasis. Patients were randomized 1:1 in two groups (SWL with VR and SWL without VR). The primary outcome of this randomized, controlled study (RCT) was an overall difference in pain levels determined by VAS-scores. Secondary outcomes were differences in comfort levels, determined by Likert-scale scores, clinical success and total delivered energy.

Results: Between January 2019 and September 2021, we enrolled 166 patients; 84 were randomized to the control arm and 82 to the VR arm. Patients without VR experienced significantly more pain compared to the VR group (mean VAS-score = 4.94 vs 4.01; p = 0.011). The mean total delivered energy was significantly higher in the VR group compared to the control group (55.2 J vs. 48.8 J; p = 0'037). No significant differences in comfort levels and clinical success were found.

Conclusion: This study supports the use of VR as a method of pain relief during shock wave lithotripsy. Higher energy levels can be achieved during the treatment while comfort levels remained equal; this however did not lead to improved clinical success.

Registration number and name of trial registry: Clinicaltrials.gov: NCT05183269. Virtual reality for pain control during extracorporeal shock wave lithotripsy: prospective, comparative, randomized study at a single institution. https://clinicaltrials.gov/ct2/show/NCT05183269?term=shock+wave+lithotripsy&cond=virtual+reality&cntry=BE&draw=2&rank=1 .

Keywords: Extracorporeal shock wave lithotripsy; Pain; Randomized controlled study; Virtual reality.