RecruitingNot ApplicableNCT07338292

VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures

VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures: a Post-marketing Clinical Investigation of REALICA

Sponsor

Istituto Oncologico Veneto IRCCS

Enrollment

56 participants

Start Date

Dec 17, 2025

Study Type

INTERVENTIONAL

Conditions

Pain Stress Anxiety Prostate Biopsy Urologic Diseases Circumcision Flexible Cystoscopy

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

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria5

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 Criteria8

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.

Interventions

DEVICEREALICA

REALICA® is a virtual reality viewer, designed to reduce stress and anxiety in patients during intervention and invasive procedure. This medical device effectively distracts the patient through interactive audiovisual content and promotes relaxation through guided visual and sound stimuli. The system provides in each setting for interactions designed to engage the patient's attention, consisting of simple games or activities, which require the participation of the patient through the use of the external controllers provided, who is then required to interact. The system operates anonymously, with no need to identify the patient or collect any sensitive data about the user. The device is configured as a "stand-alone" device, i.e., autonomous and without the need for wired connections to PCs or other external devices.

OTHERClinical Practice

Patients in the Control group will receive topical anesthesia, without application of virtual viewer.