VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures (NCT07338292) | Clinical Trial Compass
RecruitingNot Applicable
VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures
Italy56 participantsStarted 2025-12-17
Plain-language 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
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Anxiety reduction
Timeframe: Through study completion, an average of 1 year