An interventional study of Standard Local Anesthesia and Immersive Virtual Reality (VR) Headset in Prostate Biopsy, sponsored by IRCCS San Raffaele. Not yet recruiting at 1 site in Italy. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by IRCCS San Raffaele · Not applicable, Interventional, and Supportive care
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.
IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants undergo transperineal prostate biopsy performed under standard clinical practice using local anesthesia. Local anesthetic is administered according to institutional protocol prior to the procedure. No additional interventions or supportive devices are used in this arm. Patients receive routine peri-procedural monitoring and care as per standard of care.
Procedure: Standard Local Anesthesia
Participants undergo transperineal prostate biopsy performed under standard clinical practice using local anesthesia, with the addition of an immersive virtual reality (VR) headset as a supportive intervention. The VR device is applied approximately 3-5 minutes before the start of the procedure and is worn continuously throughout the biopsy. The VR experience is used as a non-pharmacological distraction tool intended to reduce peri-procedural anxiety and pain.
Device: Immersive Virtual Reality (VR) Headset
Transperineal prostate biopsy performed under standard clinical practice using local anesthesia administered according to institutional protocol. No additional supportive or experimental interventions are applied.
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.
Procedural Pain Intensity
Pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain)
Time frame: Immediately after completion of the biopsy procedure
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
Time frame: Immediately post-procedure
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.
Time frame: 1 month (Day 30 ± 5 days) after the procedure
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.
Time frame: Baseline and 1 month (Day 30 ± 5 days) after the procedure
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.
Time frame: Baseline and 1 month (Day 30 ± 5 days) after the procedure
Sexual function
Assessed using the International Index of Erectile Function (IIEF). The IIEF is a validated 15-item questionnaire assessing male sexual function. Total scores range from 5 to 75, with higher scores indicating better sexual function.
Time frame: Baseline and 1 month (Day 30 ± 5 days) after the procedure
Health-related quality of life
Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). The EORTC QLQ is a validated questionnaire assessing health-related quality of life. Scores are transformed into a 0 to 100 scale. For functional scales and global health status, higher scores indicate better quality of life, whereas for symptom scales, higher scores indicate greater symptom burden.
Time frame: Baseline and 1 month (Day 30 ± 5 days) after the procedure
Depressive symptoms
Assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item questionnaire assessing depressive symptoms. Total scores range from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
Time frame: Baseline and 1 month (Day 30 ± 5 days) after the procedure
Post-procedural complications
Collection of all reported complications related to the biopsy procedure, including vasovagal reactions and other adverse events.
Time frame: During the procedure and up to 30 days after the procedure
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
IRCCS San Raffaele