Use of a Virtual Reality Headset During Prostate Biopsy Under Local Anesthesia to Improve the Patient's Experience
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Local Anesthesia, Immersive Virtual Reality (VR) Headset.
- Who it may be relevant to
- Registry conditions: Prostate Biopsy. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of a Virtual Reality Visor (REALICA®) as an Supplementary Tool to Local Anesthesia in Patients Undergoing Prostate Biopsy: A Randomized Clinical Trial
Overview
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.
Interventions
- Procedure 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. - Device 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.
Primary outcome measures
- Procedural Pain Intensity [Time frame: Immediately after completion of the biopsy procedure]
Secondary outcome measures (8)
- Procedural anxiety [Time frame: Immediately post-procedure]
- Decision regret [Time frame: 1 month (Day 30 ± 5 days) after the procedure]
- Urinary incontinence [Time frame: Baseline and 1 month (Day 30 ± 5 days) after the procedure]
- Lower urinary tract symptoms [Time frame: Baseline and 1 month (Day 30 ± 5 days) after the procedure]
- Sexual function [Time frame: Baseline and 1 month (Day 30 ± 5 days) after the procedure]
- Health-related quality of life [Time frame: Baseline and 1 month (Day 30 ± 5 days) after the procedure]
- Depressive symptoms [Time frame: Baseline and 1 month (Day 30 ± 5 days) after the procedure]
- Post-procedural complications [Time frame: During the procedure and up to 30 days after the procedure]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Italy · 1 center
- IRCCS Ospedale San Raffaele — Milan
Identifiers
NCT: NCT07701421 · VR-biopsy