VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorIstituto Oncologico Veneto IRCCS
About this trial
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
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- REALICA
- Clinical Practice
Treatment groups
56 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov