NCT07338292 VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures
| NCT ID | NCT07338292 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Oncologico Veneto IRCCS |
| Condition | Urologic Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2025-12-17 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 56 participants in total. It began in 2025-12-17 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07338292 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Urologic Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07338292 currently recruiting?
Yes, NCT07338292 is actively recruiting participants. Contact the research team at antonio.amodeo@iov.veneto.it for enrollment information.
Where is the NCT07338292 trial being conducted?
This trial is being conducted at Padova, Italy.
Who is sponsoring the NCT07338292 clinical trial?
NCT07338292 is sponsored by Istituto Oncologico Veneto IRCCS. The trial plans to enroll 56 participants.