VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures

January 7, 2026 updated by: Istituto Oncologico Veneto IRCCS

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Routine outpatient urological procedures, including circumcision, prostate biopsy, and flexible cystoscopy, despite being minimally invasive, are often accompanied by high levels of preoperative anxiety and anticipatory pain. Inadequate management of such symptoms not only compromises patient experience and compliance with future treatments, but can also lead to procedural stress-related complications such as intraoperative hypertension and tachycardia. Consequently, the identification and implementation of effective strategies to mitigate these events are of primary importance. Traditionally, pharmacological sedatives are used to alleviate anxiety and pain; however, these can cause adverse events, require intensive monitoring, and increase healthcare costs, slowing patient turnover in outpatient settings. For this reason, non-pharmacological strategies, known as "digital sedation" and including virtual reality, music therapy, and biofeedback, are emerging as effective options to optimize patient comfort while limiting exposure to sedative drugs. In particular, medical hypnosis promotes a state of deep relaxation and focused attention, demonstrating its applicability in the management of chronic and procedural pain, as well as in anxiety reduction in various clinical settings. Among these strategies, Virtual Reality Hypnosis (VRH) combines interactive immersion in three-dimensional environments with guided hypnotic scripts, leveraging distraction and suggestion mechanisms to modulate the perception of anxiety and pain. Recent systematic reviews and meta-analyses have corroborated the effectiveness of VRH in heterogeneous contexts (bronchoscopy, interventional radiology, dentistry, and orthopedics) with significant reductions in subjective pain scores and autonomic stress parameters (heart rate, blood pressure). For example, Ahmad et al. (2020) found an average 20-30% improvement in pain and anxiety levels in cancer patients undergoing invasive procedures [8], while Georgescu et al. (2020) documented an effect size up to 0.8 for VRH analgesia in procedural settings. Zheng et al. (2022) further demonstrated an increase of over 15% in nociceptive pain threshold and favorable modulation of autonomic functions in healthy volunteers. Finally, Teh, Jia J et al. (2024), including 23 randomized trials, highlighted an average 25% decrease in intra-procedural pain and significant comfort improvement, reinforcing VRH's potential as a digital sedation tool. In the urological field, controlled studies have utilized VRH sets during flexible cystoscopy, achieving significant reductions in anxiety, pain, and hemodynamic parameters compared to controls; analogous results have been confirmed by technical feasibility and symptom decrease in rigid cystoscopies. The integration of VRH masks in minimally invasive functional urological interventions has achieved satisfaction rates exceeding 90% and reductions of up to 35% in self-reported pain. Further preliminary studies on transperineal prostate biopsy have also shown trends towards a decrease in anxiety state and increased willingness to repeat the procedure, while an ongoing trial is evaluating the effectiveness of VRH headphones on anxiety and comfort during transrectal biopsy. Finally, a recent mini-review highlighted the potential of VRH as a supportive tool for local anesthesia in outpatient urological procedures, as well as the need for further randomized studies to define specific protocols.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Padua, Italy, 35128
        • Recruiting
        • Istituto Oncologico Veneto IRCCS
        • Contact:
        • Principal Investigator:
          • Antonio Amodeo, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual reality
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.
Device: REALICA
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.
Active Comparator: Control group
Control group will be treated according to clinical practice.
Other: Clinical Practice
Patients in the Control group will receive topical anesthesia, without application of virtual viewer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety reduction
Time Frame: Through study completion, an average of 1 year

Evaluate the impact of immersive virtual reality on reducing anxiety, in patients undergoing minimally invasive ambulatory urological procedures, such as prostate biopsy, flexible cystoscopy, and circumcision using validated patient-reported scales STAI (State-Trait Anxiety Inventory), before and after invasive procedure.

The minimum value is 1 = almost never and the maximum value is 4=almost always
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of pain
Time Frame: Through study completion, an average of 1 year
Assess the intensity of pain perceived by patients during the procedure with the use of REALICA. Measurement of pain intensity perceived by patients during the procedure (T1) with the use of a virtual reality headset, assessed through validated scale as the Visual Analog Scale (VAS). The minimum value is Left = no pain; the maximum value is right = the worst pain imaginable
Through study completion, an average of 1 year
Intensity of pain
Time Frame: Through study completion, an average of 1 year

Assess the intensity of pain perceived by patients during the procedure with the use of REALICA. Measurement of pain intensity perceived by patients during the procedure (T1) with the use of a virtual reality headset, assessed through validated scale as the Numeric Rating Scale (NRS).

The minimum value is 0 = no pain, the maximum value is 10 = the worst pain imaginable.
Through study completion, an average of 1 year
Pain levels
Time Frame: Through study completion, an average of 1 year
Evaluation of the reduction in pain levels associated with minimally invasive ambulatory urological procedures attributable to the use of virtual reality, using validated patient-reported scale VAS (Visual Analog Scale). The minimum value is Left = no pain; the maximum value is right = the worst pain imaginable
Through study completion, an average of 1 year
Pain levels
Time Frame: Through study completion, an average of 1 year
Evaluation of the reduction in pain levels associated with minimally invasive ambulatory urological procedures attributable to the use of virtual reality, using validated patient-reported scale NRS (Numeric Rating Scale). The minimum value is 0 = no pain, the maximum value is 10 = the worst pain imaginable.
Through study completion, an average of 1 year
Feasibility and acceptability of REALICA®
Time Frame: Through study completion, an average of 1 year
Evaluation of feasibility and acceptability of virtual reality headset use in the intervention group, based on the proportion of patients who tolerate and complete the VR intervention, along with feedback collected from patients and healthcare professionals via the modified System Usability Scale (SUS) questionnaires and Likert scales, which will be administered to patients and staff upon completion of the procedure. The minimum value is 1 = Strongly agree, the maximum value is 5 = strongly disagree.
Through study completion, an average of 1 year
Patient Satisfaction Questionnaire
Time Frame: Through study completion, an average of 1 year
Assess patient satisfaction with the virtual reality intervention using the Patient Satisfaction Questionnaire (PSQ). The minimum value is 1 = Strongly agree, the maximum value is 5 = strongly disagree.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Oncologico Veneto IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOV-UD-01-2025-VIPER_URO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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