Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
ID07338292

Virtual Reality Induced Pain and Anxiety Relief in Outpatient Urological Procedures A Post-marketing Clinical Investigation of REALICA

Led by Istituto Oncologico Veneto IRCCS · Updated on 2026-01-13

56

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of Virtual Reality Hypnosis (VRH) to reduce anxiety and pain during outpatient urological procedures such as circumcision, prostate biopsy, and flexible cystoscopy. These procedures, though minimally invasive, often cause significant stress and discomfort. The study focuses on the effectiveness of the REALICA4 virtual reality device, which has shown promise in other medical fields, to improve patient comfort and reduce reliance on sedative drugs, while addressing procedural stress-related complications like hypertension and tachycardia. The study compares two groups: one using the REALICA4 virtual reality viewer and another receiving standard clinical care with topical anesthesia. REALICA4 provides immersive audiovisual content with interactive games and guided relaxation to distract and calm patients during procedures. The device operates autonomously without needing connections to external equipment and does not collect personal data. The control group will follow usual clinical practice without virtual reality intervention. Participants will be monitored throughout the study, which lasts about one year, to assess anxiety reduction and pain intensity. Researchers will collect data on patient satisfaction, feasibility of using the device, and overall acceptability. Assessments include questionnaires and evaluations of stress-related parameters. The study aims to provide detailed information on how VRH impacts patient experience and procedural outcomes during these urological interventions.

CONDITIONS

Brief Title

VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 years or older
  • Undergoing one of the specified urological procedures (circumcision, prostate biopsy, flexible cystoscopy) for the first time
  • Eligible for minimally invasive ambulatory urological procedures, possibly requiring vascular access
  • Able to understand instructions and complete study questionnaires
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Absolute contraindications to the planned urological procedure, such as active urinary tract infection or anatomical urethral abnormalities
  • Recent urological manipulations like urethral dilation, bladder biopsy, or double-J stent insertion/removal
  • Medical contraindications to virtual reality use, including uncontrolled photosensitive epilepsy or relevant neurological, ophthalmologic, or ear-nose-throat disorders
  • Severe psychiatric disorders or major cardiovascular diseases that may affect participation
  • Previous adverse reactions to virtual reality exposure
  • Use of analgesic medications within 24 hours before the procedure
  • Use of drugs that impair consciousness or the ability to complete psychological assessments
  • Severe communication disabilities or significant hearing impairment preventing questionnaire completion

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of the procedure

Participants undergo routine outpatient urological procedures and use the REALICA® virtual reality device or receive standard topical anesthesia during the procedure to reduce anxiety and pain.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 1 year

Participants are followed for up to one year to assess anxiety reduction, pain intensity, feasibility, acceptability of the device, and patient satisfaction.

Follow-up visits as scheduled during the study completion period

Trial Site Locations

Total: 1 location

1

Istituto Oncologico Veneto IRCCS

Padova, Italy, 35128

Actively Recruiting

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Research Team

A

Antonio Amodeo, MD

G

Gian Luca De Salvo, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

The Effect of Preoperative Pain, Fear, and Anxiety on Postoperative Pain in Urological Surgery Patients: A Descriptive and Correlational Study.

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https://pubmed.ncbi.nlm.nih.gov/37921714

Psychological interventions using virtual reality for pain associated with medical procedures: a systematic review and meta-analysis.

Raluca Georgescu, Liviu A Fodor, Anca Dobrean...

https://pubmed.ncbi.nlm.nih.gov/31456530

Effect of Virtual Reality Hypnosis on Pain Threshold and Neurophysiological and Autonomic Biomarkers in Healthy Volunteers: Prospective Randomized Crossover Study.

Claire Terzulli, Meggane Melchior, Laurent Goffin...

https://pubmed.ncbi.nlm.nih.gov/35904872

Prospective randomized controlled trial to evaluate effectiveness of virtual reality to decrease anxiety in office-based flexible cystoscopy patients.

Chinnakhet Ketsuwan, Wijittra Matang, Wattanachai Ratanapornsompong...

https://pubmed.ncbi.nlm.nih.gov/36048232

Influence of Virtual Reality Devices on Pain and Anxiety in Patients Undergoing Cystoscopy Performed under Local Anaesthesia.

Mateusz Łuczak, Łukasz Nowak, Joanna Chorbińska...

https://pubmed.ncbi.nlm.nih.gov/34834565