Use of a Virtual Reality Visor (REALICA®) as an Supplementary Tool to Local Anesthesia in Patients Undergoing Prostate Biopsy: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Procedural Pain Intensity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm A (Control)- Transperineal Prostate Biopsy under Local Anesthesia
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.
干预措施: Standard Local Anesthesia (Procedure)
Arm B (Experimental)- Local anesthesia + immersive VR headset
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.
干预措施: Immersive Virtual Reality (VR) Headset (Device)
结局指标
主要结局
Procedural Pain Intensity
时间窗: 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)
次要结局
- Procedural anxiety(Immediately post-procedure)
- Decision regret(1 month (Day 30 ± 5 days) after the procedure)
- Urinary incontinence(Baseline and 1 month (Day 30 ± 5 days) after the procedure)
- Lower urinary tract symptoms(Baseline and 1 month (Day 30 ± 5 days) after the procedure)
- Sexual function(Baseline and 1 month (Day 30 ± 5 days) after the procedure)
- Health-related quality of life(Baseline and 1 month (Day 30 ± 5 days) after the procedure)
- Depressive symptoms(Baseline and 1 month (Day 30 ± 5 days) after the procedure)
- Post-procedural complications(During the procedure and up to 30 days after the procedure)
研究者
Prof. Alberto Briganti
Full Professor
IRCCS San Raffaele