Virtual Reality to Reduce Pain and Anxiety During Extracorporeal Shock Wave Lithotripsy

The objective of this study is to evaluate the impact of intraprocedural Virtual Reality (VR) as a non-pharmacological intervention for mitigating anxiety and pain during Extracorporeal Shock Wave Lithotripsy (ESWL). The hypothesis is that VR can effectively reduce both pain and anxiety levels in patients by diverting their cognitive focus, potentially leading to a decrease in pharmacological intervention requirements. The primary outcome is pain at energy level 900 during ESWL for the intervention and the control group. The secondary outcomes are as follows: * Type and dose of analgesia * Conductance scores/values * Anxiety levels * Patient satisfaction * Procedure duration * Adverse events Participants will be randomized into either the intervention or control group. Both groups will undergo ESWL according to standard treatment; however, the intervention group will wear a Virtual Reality headset and noise-cancelling headphones during the procedure, while the control group will not

NCT Number	NCT06616324
Lead Sponsor	Zealand University Hospital
Conditions	Anxiety, Pain, Virtual Reality, Lithotripsy
Enrollment	72 participants
Start Date	2024-10-24
Primary Completion	2025-10-01 (estimated)
Study Completion	2025-10-01 (estimated)
Updated on ClinicalTrials.gov	2025-09-23