Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
NCT07338292

VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures

Led by Istituto Oncologico Veneto IRCCS · Updated on 2026-01-13

56

Participants Needed

1

Research Sites

45 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Though the efficacy of VRH is documented in various outpatient urological procedures and has provided promising preliminary information in prostate biopsy, its systematic use in urology remains poorly studied. Considering the potential of invasive urological procedures to induce significant patient discomfort, the application of innovative immersive approaches, such as those offered by medical devices, could lead to an overall clinical benefit. Among these, REALICA® (available from https://REALICA.io/en/), a class I CE medical device, widely used in hospitals and validated by numerous studies, represents a valuable resource in urology, supported by high satisfaction rates received in abdominal surgery and extracorporeal lithotripsy

CONDITIONS

Official Title

VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 years or older
  • Undergoing one of the specified urological procedures for the first time
  • Eligible for minimally invasive outpatient urological procedures such as circumcision, prostate biopsy, or flexible cystoscopy
  • Able to understand instructions and complete study questionnaires
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Absolute contraindications to planned urological procedure (e.g., active urinary tract infection, urethral abnormalities)
  • Recent urological procedures like urethral dilation, bladder biopsy, or stent insertion/removal
  • Medical issues preventing virtual reality use, including uncontrolled photosensitive epilepsy and significant neurological, eye, or ear disorders
  • Severe psychiatric disorders or major cardiovascular diseases interfering with participation
  • Previous adverse reactions to virtual reality
  • Use of analgesic medications within 24 hours before procedure
  • Use of drugs affecting consciousness or ability to complete psychological assessments
  • Severe communication disabilities or hearing impairment preventing questionnaire completion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Istituto Oncologico Veneto IRCCS

Padova, Italy, 35128

Actively Recruiting

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Research Team

A

Antonio Amodeo, MD

CONTACT

G

Gian Luca De Salvo, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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