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VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures

NCT07338292 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-01-13

No results posted yet for this study

Summary

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

  • Urologic Diseases
  • Prostate Biopsy
  • Flexible Cystoscopy
  • Circumcision
  • Stress
  • Anxiety
  • Pain

Interventions

DEVICE

REALICA

REALICA® is a virtual reality viewer, designed to reduce stress and anxiety in patients during intervention and invasive procedure. This medical device effectively distracts the patient through interactive audiovisual content and promotes relaxation through guided visual and sound stimuli. The system provides in each setting for interactions designed to engage the patient's attention, consisting of simple games or activities, which require the participation of the patient through the use of the external controllers provided, who is then required to interact. The system operates anonymously, with no need to identify the patient or collect any sensitive data about the user. The device is configured as a "stand-alone" device, i.e., autonomous and without the need for wired connections to PCs or other external devices.

OTHER

Clinical Practice

Patients in the Control group will receive topical anesthesia, without application of virtual viewer.

Sponsors & Collaborators

  • Istituto Oncologico Veneto IRCCS

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-17
Primary Completion
2026-09-30
Completion
2026-10-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07338292 on ClinicalTrials.gov