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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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.
• Устройство 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.

Первичные конечные точки

• Procedural Pain Intensity [Срок оценки: Immediately after completion of the biopsy procedure]

Вторичные конечные точки (8)

• Procedural anxiety [Срок оценки: Immediately post-procedure]
• Decision regret [Срок оценки: 1 month (Day 30 ± 5 days) after the procedure]
• Urinary incontinence [Срок оценки: Baseline and 1 month (Day 30 ± 5 days) after the procedure]
• Lower urinary tract symptoms [Срок оценки: Baseline and 1 month (Day 30 ± 5 days) after the procedure]
• Sexual function [Срок оценки: Baseline and 1 month (Day 30 ± 5 days) after the procedure]
• Health-related quality of life [Срок оценки: Baseline and 1 month (Day 30 ± 5 days) after the procedure]
• Depressive symptoms [Срок оценки: Baseline and 1 month (Day 30 ± 5 days) after the procedure]
• Post-procedural complications [Срок оценки: During the procedure and up to 30 days after the procedure]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• IRCCS Ospedale San Raffaele — Milan

Идентификаторы

NCT: NCT07701421 · VR-biopsy

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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