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NCT Number: NCT07701421

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

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.

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Key information

Conditions

Prostate Biopsy

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Procedural anxiety

    Time frame: Immediately post-procedure

    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

  2. Decision regret

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

    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.

  3. Urinary incontinence

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

    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.

  4. Lower urinary tract symptoms

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

    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.

  5. Sexual function

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

    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.

  6. Health-related quality of life

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

    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.

  7. Depressive symptoms

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

    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.

  8. Post-procedural complications

    Time frame: During the procedure and up to 30 days after the procedure

    Collection of all reported complications related to the biopsy procedure, including vasovagal reactions and other adverse events.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

Use of a Virtual Reality Visor (REALICA®) as an Supplementary Tool to Local Anesthesia in Patients Undergoing Prostate Biopsy: A Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2028
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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