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

NCT07701421 | Not Yet Recruiting

• 1 other identifier: VR-biopsy
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Biopsy

Outcome Measures

Primary Outcomes (1)

• Procedural Pain Intensity

  Pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain)

  Immediately after completion of the biopsy procedure

Secondary Outcomes (8)

• Procedural anxiety

  Immediately post-procedure

• Decision regret

  1 month (Day 30 ± 5 days) after the procedure

• Urinary incontinence

  Baseline and 1 month (Day 30 ± 5 days) after the procedure

• Lower urinary tract symptoms

  Baseline and 1 month (Day 30 ± 5 days) after the procedure

• Sexual function

  Baseline and 1 month (Day 30 ± 5 days) after the procedure

Study Arms (2)

Arm A (Control)- Transperineal Prostate Biopsy under Local Anesthesia

ACTIVE COMPARATOR

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

Arm B (Experimental)- Local anesthesia + immersive VR headset

EXPERIMENTAL

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

Interventions

Standard Local Anesthesia PROCEDURE

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

Arm A (Control)- Transperineal Prostate Biopsy under Local Anesthesia

Immersive Virtual Reality (VR) Headset DEVICE

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.

Arm B (Experimental)- Local anesthesia + immersive VR headset

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Italy, 20132, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

IT (1)