VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures

Recruiting now · Not applicable

Conditions studied: Urologic Diseases, Prostate Biopsy, Flexible Cystoscopy, Circumcision, Stress, Anxiety, Pain

In brief

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

Key facts

Study ID

NCT07338292

Run by

Istituto Oncologico Veneto IRCCS

People needed

56

Starts

2025-12-17

Expected to finish

2026-10-31

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male/female with age ≥ 18 years
• Patient who are undergoing one of the interventions mentioned in the study for the first time;
• Eligibility for minimally invasive ambulatory urological procedures, possibly requiring vascular access (circumcision, prostate biopsy, flexible cystoscopy);
• Ability to understand instructions and complete study questionnaires;
• Signed informed consent.

You may not qualify if…

• Absolute contraindications to the planned urological procedure (e.g., active urinary tract infection, anatomical urethral abnormalities);
• Recent urological manipulations (e.g., urethral dilation, bladder biopsy, insertion or removal of a double-J stent);
• Medical contraindications to the use of virtual reality, including uncontrolled photosensitive epilepsy and relevant neurological, ophthalmologic, or otolaryngologic disorders;
• Presence of severe psychiatric disorders or major cardiovascular diseases that may interfere with study participation;
• Previous adverse reactions to virtual reality exposure;
• Use of analgesic medications within 24 hours prior to the procedure;
• Use of drugs that may alter consciousness or impair the ability to complete psychological assessments;
• Severe communication disabilities or significant hearing impairment that would prevent completion of questionnaires.

Where it is running

• Istituto Oncologico Veneto IRCCS — Padova, Italy (enrolling)

Full record on ClinicalTrials.gov

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