Virtual reality to reduce pain and anxiety during outpatient urology procedures

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

This trial will try a virtual reality headset (REALICA®) to reduce pain and anxiety for adults having outpatient urology procedures such as circumcision, prostate biopsy, or flexible cystoscopy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: Istituto Oncologico Veneto IRCCS (other)
• Locations: 1 site (Padova)
• Trial ID: NCT07338292 on ClinicalTrials.gov

What this trial studies

Outpatient urological procedures can cause significant preoperative anxiety and anticipatory pain, which may lead to physiological stress and poorer patient experience. This trial uses REALICA®, a CE-marked virtual reality hypnosis system, delivered during routine ambulatory urological procedures to provide immersive relaxation and guided hypnotic scripts. Participants receiving the device will be compared with routine clinical practice to determine whether VRH lowers procedural pain and anxiety and limits need for pharmacological sedation. The study also monitors patient satisfaction and peri-procedural stress indicators to gauge clinical and operational benefits.

Who should consider this trial

Good fit: Adults (age ≥18) who are undergoing one of the listed outpatient urological procedures for the first time, can understand instructions, and can give informed consent are eligible.

Not a fit: Patients with contraindications to virtual reality (e.g., uncontrolled photosensitive epilepsy, significant neurological/ophthalmologic/ENT disorders), severe psychiatric or major cardiovascular disease, recent relevant urologic manipulations, or absolute contraindications to the planned procedure are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the intervention could reduce patient-reported pain and anxiety during procedures, lower sedative use, and improve overall patient experience and throughput in outpatient urology.

How similar studies have performed: Previous studies of virtual reality and virtual reality hypnosis have shown reductions in procedural pain and anxiety in various settings and preliminary evidence in prostate biopsy is promising, but systematic trials in urology remain limited.

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.

Where this trial is running

Padova

• Istituto Oncologico Veneto IRCCS — Padova, Italy (RECRUITING)

Study contacts

• Study coordinator: Antonio Amodeo, MD

Conditions: Urologic Diseases, Prostate Biopsy, Flexible Cystoscopy, Circumcision, Stress, Anxiety, Pain, virtual reality