Evaluation of the effect of virtual reality hypnosis on pain through attentional diversion during prostate biopsies under local anesthesia (HYPNOSURG-VR): a study protocol.

Background: Prostate cancer is the second most commonly diagnosed cancer in men worldwide. Prostate biopsies are essential for diagnosis but often induce significant pain and anxiety despite local anesthesia. Virtual reality (VR) has emerged as a promising non-pharmacological tool for pain management during medical procedures. This study aims to assess the effect of virtual reality hypnosis (VRH) as an adjunct to standard local anesthesia during prostate biopsies. Methods: This single-center, prospective, randomized, controlled, parallel-group, single-blind trial will compare standard prostate biopsies under local anesthesia with and without VRH. A total of 130 patients will be randomized in a 1:1 ratio to receive either standard care with local anesthesia alone or standard care plus VRH. The VRH will be initiated 15 minutes pre-procedure and continue throughout. The primary outcome is the maximum pain assessed using a 0-10 Numerical Pain Rating Scale immediately post-procedure by a blinded assessor. Secondary outcomes include post-procedure pain, anxiety, physiological stress response, immersion level, patient satisfaction, procedural success, additional analgesia needs, procedure duration, and adverse events. Follow-up will occur at 1 month. Discussion: This trial will provide high-quality evidence regarding VRH effectiveness as a non-pharmacological adjunct for pain management during prostate biopsies. By targeting both anticipatory anxiety and procedural pain, this approach may significantly improve patient comfort. If effective, this technique could transform the standard of care for prostate biopsies and potentially extend to other invasive urological procedures.