VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures
Recruiting · NCT07338292 · Interventional (participants receive a specific treatment) · Lead sponsor: Istituto Oncologico Veneto IRCCS
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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.
Where it is running
1 location listed.
- Istituto Oncologico Veneto IRCCS - Padova, Italy