Virtual reality to reduce pain and anxiety during outpatient urology procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Istituto Oncologico Veneto IRCCS
  Padova, Italy Recruiting

Study contacts

• Study coordinator: Antonio Amodeo, MD
• Email: antonio.amodeo@iov.veneto.it
• Phone: 0423-421321

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.