Introduction: Extracorporeal shock wave lithotripsy (ESWL) is an effective but painful treatment modality for kidney stone disease, which may require the use of opioids. Virtual reality (VR) creates an immersive environment known to reduce the perception of pain. The objective of this randomized pilot clinical trial was to evaluate the feasibility of the protocol and the effect of VR on pain, anxiety and opioids consumption. 

Methods: Patients with radiopaque kidney stones undergoing ESWL for the first time were randomized 2:1 into VR or control group, targeting a sample size of 30 participants. The VR group wore headsets producing a visual and audio stimulation for 20 minutes before ESWL, while the control group had a break in a quiet room. Pain intensity was assessed using a visual analog scale and anxiety using the IASTA questionnaire pre and post ESWL. Fentanyl consumption was recorded by dose of 50mcg injected upon patient’s request. Technicians performing the ESWL sessions were blinded to group allocation and followed the same protocol to gradually increase the intensity of the ESWL.

Results: Out of 267 ESWL done in our institution from November 2022 to May 2024, 69 patients (25.8%) were eligible. 30 were included (18 in VR group, 12 in control group; mean age 57, range 21-82). VR was well tolerated, except for one patient who asked to stop after 5 minutes. Pain intensity was significantly lower in the VR group (3.8/10) compared to controls (5.9/10, p=0.043). No differences were found in the average ESWL power (69 vs 67%, p=0.669), antalgic doses used (1.4 vs 1.4, p=0.753) and IASTA questionnaires (p=0.263), in both groups.

Conclusions: Results show promising outcomes of VR during ESWL in terms of pain perception, although antalgic doses and anxiety were not reduced. VR was well-tolerated by patients. The implementation of an adequately powered randomized controlled trial will face a low recruitment rate and appropriate strategies will have to be elaborated.