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.
The participant provides written informed consent for the trial
Male participants who are at least 18 years of age on the day of signing informed consent
Men undergoing transperineal prostate biopsy under local anesthesia
Visual or hearing impairment that would prevent effective use of the virtual reality device
History of epilepsy or seizure disorders
Severe motion sickness or known susceptibility to cybersickness
Severe psychiatric disorders that, in the investigator's judgment, could interfere with study participation or outcome assessment
Parallel
Standard Local Anesthesia
Procedure/SurgeryTransperineal 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
DeviceTransperineal 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.
Procedural Pain Intensity
Pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain)
Procedural anxiety
Assessed using the State-Trait Anxiety Inventory Form Y-1 (STAI-Y1). The STAI-Y1 total score ranges from 20 to 80, with higher scores indicating greater anxiety
Decision regret
Assessed using the validated Decision Regret Scale (DRS). The Decision Regret Scale is a 5-item questionnaire assessing regret following a healthcare decision. Scores range from 0 to 100, with higher scores indicating greater decision regret.
Urinary incontinence
Assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF). Total scores range from 0 to 21, with higher scores indicating greater severity of urinary incontinence.
Lower urinary tract symptoms
Assessed using the International Prostate Symptom Score (IPSS). Total scores range from 0 to 35, with higher scores indicating greater severity of lower urinary tract symptoms.
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