Use of a Virtual Reality Headset During Prostate Biopsy Under Local Anesthesia to Improve the Patient's Experience

Condition(s) studied

Investigational drug(s) / intervention(s)

Standard Local Anesthesia: Transperineal prostate biopsy performed under standard clinical practice using local anesthesia administered according to institutional protocol. No additional supportive or experimental interventions are applied.

Immersive Virtual Reality (VR) Headset: Transperineal prostate biopsy performed under standard local anesthesia with the addition of an immersive virtual reality (VR) headset used as a non-pharmacological distraction tool. The VR device is applied approximately 3-5 minutes before the start of the procedure and worn continuously throughout the biopsy.

Study summary

This is a post-market clinical investigation evaluating the effect of immersive virtual reality (VR) as an adjunct to standard local anesthesia during transperineal prostate biopsy.

Transperineal prostate biopsy under local anesthesia is commonly associated with patient anxiety, procedural discomfort, and vasovagal reactions, which may negatively impact patient experience and procedural tolerability. Non-pharmacological distraction techniques such as immersive VR have shown potential to reduce perceived pain and anxiety during short, invasive medical procedures by modulating cognitive attention and emotional response.

This study investigates whether the use of an immersive VR headset, added to standard local anesthesia, can reduce peri-procedural anxiety and pain compared to standard care alone. The intervention is designed to provide continuous audiovisual immersive distraction starting shortly before the procedure and continuing throughout the biopsy, without altering standard clinical workflow or increasing procedural invasiveness.

This is a randomized, controlled, parallel-group, 1:1 superiority trial with a single-blind (assessor-blinded) design. Participants undergoing transperineal prostate biopsy under local anesthesia will be randomly assigned to one of two groups: standard local anesthesia alone (control arm) or standard local anesthesia plus immersive VR (experimental arm).

The primary objective is to evaluate whether immersive VR reduces peri-procedural anxiety and pain compared with standard local anesthesia alone. Secondary objectives may include evaluation of patient satisfaction, tolerability of the VR intervention, and incidence of vasovagal reactions or procedural interruptions.

The study aims to generate evidence on the feasibility and clinical benefit of integrating immersive VR as a non-pharmacological supportive tool in urological diagnostic procedures.

Eligibility

Primary outcome measure(s)

• Procedural Pain Intensity — Immediately after completion of the biopsy procedure
  Pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain)

Trial sites (1)

More IRCCS San Raffaele trials in Italy

Other trials for the same condition