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Could a VR headset make prostate biopsies less painful?

NCT ID NCT07701421

Symptom relief Sponsor: IRCCS San Raffaele Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This trial investigates whether wearing an immersive virtual reality (VR) headset during a prostate biopsy can reduce pain and anxiety beyond what local anesthesia alone provides. About 200 men undergoing a transperineal prostate biopsy will be randomly assigned to receive either standard local anesthesia or standard anesthesia plus the VR headset, which provides audiovisual distraction. The study measures pain, anxiety, patient satisfaction, and any side effects like motion sickness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Immersive virtual reality headset used as a non-pharmacological distraction tool during prostate biopsy
What this could lead to
If it works, this could offer a simple, drug-free way to make prostate biopsies less stressful and painful for patients.
What could go wrong
This is a relatively small, early-stage study, and the benefit of VR may be modest or not apply to everyone. Some people may find the headset uncomfortable or experience motion sickness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate biopsy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • IRCCS Ospedale San Raffaele

    Milan, Italy, 20132, Italy

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