Prostate BiopsyNCT07701421
Use of a Virtual Reality Headset During Prostate Biopsy Under Local Anesthesia to Improve the Patient's Experience
A study testing Standard Local Anesthesia and Immersive Virtual Reality (VR) Headset in people with Prostate Biopsy, run by IRCCS San Raffaele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Biopsy
- What is being tested?
- Standard Local Anesthesia and Immersive Virtual Reality (VR) Headset
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Simone Scuderi, +39 02 2643 6922, scuderi.simone@hsr.it
About this study
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
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.
Read more
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
- Being tested
- Standard Local Anesthesia, Immersive Virtual Reality (VR) Headset
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Local AnesthesiaProcedure or surgery
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) HeadsetDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Immersive Virtual Reality (VR) Headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Pain Intensity
Pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain)
Measured: Immediately after completion of the biopsy procedure
Secondary outcomes (8)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the procedure and up to 30 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate BiopsyStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Alberto Briganti, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07701421
- Sponsor's protocol ID
- VR-biopsy
- Status last verified
- Nov 2026
- First submitted
- 30 Jun 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07701421
- Acronym / sponsor ID
- VR-biopsy
- Conditions
- Prostate Biopsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (Control)- Transperineal Prostate Biopsy under Local Anesthesia | Active comparator | Procedure: Standard Local AnesthesiaParticipants 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. |
| Arm B (Experimental)- Local anesthesia + immersive VR headset | Experimental | Device: Immersive Virtual Reality (VR) HeadsetParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Local AnesthesiaTransperineal prostate biopsy performed under standard clinical practice using local anesthesia administered according to institutional protocol. No additional supportive or experimental interventions are applied. | Procedure or surgery | Arm A (Control)- Transperineal Prostate Biopsy under Local Anesthesia |
| Immersive Virtual Reality (VR) HeadsetTransperineal 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. | Device | Arm B (Experimental)- Local anesthesia + immersive VR headset |
Primary outcome
Procedural Pain Intensity
Time frame: 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)
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Local Anesthesia and Immersive Virtual Reality (VR) Headset in people with Prostate Biopsy, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Pain Intensity (time frame: Immediately after completion of the biopsy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.