RecruitingNot ApplicableNCT07338292

VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures

VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures: a Post-marketing Clinical Investigation of REALICA


Sponsor

Istituto Oncologico Veneto IRCCS

Enrollment

56 participants

Start Date

Dec 17, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether wearing a virtual reality headset during minor outpatient urology procedures — such as prostate biopsies, flexible bladder camera examinations (cystoscopy), or circumcisions — can reduce pain and anxiety without medication. **You may be eligible if...** - You are 18 or older (male or female) - You are having one of these procedures for the first time: prostate biopsy, flexible cystoscopy, or circumcision - You are able to understand instructions and fill out questionnaires **You may NOT be eligible if...** - You have a medical reason why the planned urological procedure cannot be done (e.g., active urinary infection) - You have previously had similar urological procedures recently - You have epilepsy triggered by light or flashing, or relevant eye or ear conditions that make VR unsafe - You have severe psychiatric illness or major heart disease - You took pain medication in the 24 hours before the procedure - You have significant hearing problems or communication difficulties Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEREALICA

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.

OTHERClinical Practice

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


Locations(1)

Istituto Oncologico Veneto IRCCS

Padova, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07338292


Related Trials