Urologic DiseasesNCT07338292
VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures
A study testing REALICA and Clinical Practice in people with Urologic Diseases and Prostate Biopsy, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Urologic Diseases, Prostate Biopsy, Flexible Cystoscopy
- What is being tested?
- REALICA and Clinical Practice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteItaly
- Study dates
- 17 Dec 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Oncologico Veneto IRCCS
Padova, 35128
Antonio Amodeo, MD, 0423 421321 ext. +39, antonio.amodeo@iov.veneto.it
Gian Luca De Salvo, MD, 049 8215710 ext. +39, clinical.trial@iov.veneto.it
About this study
Official title: 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
Read the 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.
- Conditions
- Urologic Diseases, Prostate Biopsy, Flexible Cystoscopy, Circumcision, Stress, Anxiety
- Being tested
- REALICA, Clinical Practice
- Keywords
- virtual reality, medical device
- Medical subject headings
- Urologic Diseases, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REALICADevice
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.
Clinical PracticeOther
Patients in the Control group will receive topical anesthesia, without application of virtual viewer.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | 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. Receives: Device: REALICA |
| Control group | Active comparator | Control group will be treated according to clinical practice. Receives: Other: Clinical Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety reduction
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
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Intensity of pain
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
Measured: Through study completion, an average of 1 year
Intensity of pain
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.
Measured: Through study completion, an average of 1 year
Pain levels
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
Measured: Through study completion, an average of 1 year
Pain levels
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.
Measured: Through study completion, an average of 1 year
Feasibility and acceptability of REALICA®
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.
Measured: Through study completion, an average of 1 year
Patient Satisfaction Questionnaire
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start17 Dec 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Oncologico Veneto IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338292
- Sponsor's protocol ID
- IOV-UD-01-2025-VIPER_URO
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Deniz Dogan S, Yurtseven S, Arslan S. The Effect of Preoperative Pain, Fear, and Anxiety on Postoperative Pain in Urological Surgery Patients: A Descriptive and Correlational Study. J Perianesth Nurs. 2024 Apr;39(2):202-206. doi: 10.1016/j.jopan.2023.07.013. Epub 2023 Nov 3.
PubMed 37921714Jiao D. Advancing personalized digital therapeutics: integrating music therapy, brainwave entrainment methods, and AI-driven biofeedback. Front Digit Health. 2025 Feb 25;7:1552396. doi: 10.3389/fdgth.2025.1552396. eCollection 2025.
PubMed 40070544Terzulli C, Chauvin C, Champagnol Di-Liberti C, Faisan S, Goffin L, Gianesini C, Graff D, Dufour A, Laroche E, Salvat E, Poisbeau P. Virtual reality hypnosis diminishes experimental cold pain and alters autonomic responses. Front Pain Res (Lausanne). 2023 Nov 2;4:1237090. doi: 10.3389/fpain.2023.1237090. eCollection 2023.
PubMed 38028428Rizzo MG Jr, Costello JP 2nd, Luxenburg D, Cohen JL, Alberti N, Kaplan LD. Augmented Reality for Perioperative Anxiety in Patients Undergoing Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2329310. doi: 10.1001/jamanetworkopen.2023.29310.
PubMed 37589975Ahmad M, Bani Mohammad E, Anshasi HA. Virtual Reality Technology for Pain and Anxiety Management among Patients with Cancer: A Systematic Review. Pain Manag Nurs. 2020 Dec;21(6):601-607. doi: 10.1016/j.pmn.2020.04.002. Epub 2020 May 15.
PubMed 32423641Georgescu R, Fodor LA, Dobrean A, Cristea IA. Psychological interventions using virtual reality for pain associated with medical procedures: a systematic review and meta-analysis. Psychol Med. 2020 Aug;50(11):1795-1807. doi: 10.1017/S0033291719001855. Epub 2019 Aug 28.
PubMed 31456530Terzulli C, Melchior M, Goffin L, Faisan S, Gianesini C, Graff D, Dufour A, Laroche E, Chauvin C, Poisbeau P. Effect of Virtual Reality Hypnosis on Pain Threshold and Neurophysiological and Autonomic Biomarkers in Healthy Volunteers: Prospective Randomized Crossover Study. J Med Internet Res. 2022 Jul 29;24(7):e33255. doi: 10.2196/33255.
PubMed 35904872Teh JJ, Pascoe DJ, Hafeji S, Parchure R, Koczoski A, Rimmer MP, Khan KS, Al Wattar BH. Efficacy of virtual reality for pain relief in medical procedures: a systematic review and meta-analysis. BMC Med. 2024 Feb 14;22(1):64. doi: 10.1186/s12916-024-03266-6.
PubMed 38355563Ketsuwan C, Matang W, Ratanapornsompong W, Sangkum P, Phengsalae Y, Kongchareonsombat W, Jongwannasiri M. Prospective randomized controlled trial to evaluate effectiveness of virtual reality to decrease anxiety in office-based flexible cystoscopy patients. World J Urol. 2022 Oct;40(10):2575-2581. doi: 10.1007/s00345-022-04142-9. Epub 2022 Sep 1.
PubMed 36048232Luczak M, Nowak L, Chorbinska J, Galik K, Kielb P, Laszkiewicz J, Tukiendorf A, Koscielska-Kasprzak K, Malkiewicz B, Zdrojowy R, Szydelko T, Krajewski W. Influence of Virtual Reality Devices on Pain and Anxiety in Patients Undergoing Cystoscopy Performed under Local Anaesthesia. J Pers Med. 2021 Nov 16;11(11):1214. doi: 10.3390/jpm11111214.
PubMed 34834565Geretto P, De Cillis S, Candela L, Germain T, Vienney N, Felber M, Phe V. Integrating a Virtual Reality Mask in Functional Urological Surgeries Under Local Anesthesia: A Prospective Cohort Study on Utility and Satisfaction. Urology. 2025 Feb;196:93-99. doi: 10.1016/j.urology.2024.11.007. Epub 2024 Nov 14.
PubMed 39547279Perucchini F, Baumeister P, Fankhauser CD. Beyond Anesthesia: A Mini Review of Virtual Reality as an Adjunct in Urological Procedures. Eur Urol Focus. 2025 May;11(3):511-514. doi: 10.1016/j.euf.2025.01.007. Epub 2025 Jan 22.
PubMed 39848858Candela L, Ventimiglia E, Corrales M, Sierra Del Rio A, Villa L, Goumas IK, Salonia A, Montorsi F, Doizi S, Traxer O. The Use of a Virtual Reality Device (HypnoVR) During Extracorporeal Shockwave Lithotripsy for Treatment of Urinary Stones: Initial Results of a Clinical Protocol. Urology. 2023 May;175:13-17. doi: 10.1016/j.urology.2023.01.048. Epub 2023 Feb 15.
PubMed 36796544Carannante F, Capolupo GT, Miacci V, Ferri C, Agro FE, Caricato M, D'Agostino F. The effect of virtual reality hypnosis (HypnoVR) in patients undergoing inguinal hernia repair under local anesthesia. A preliminary report. Langenbecks Arch Surg. 2024 Oct 29;409(1):329. doi: 10.1007/s00423-024-03524-4.
PubMed 39470831
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures: a Post-marketing Clinical Investigation of REALICA
- ClinicalTrials.gov ID
- NCT07338292
- Acronym / sponsor ID
- IOV-UD-01-2025-VIPER_URO
- Conditions
- Urologic Diseases, Prostate Biopsy, Flexible Cystoscopy, Circumcision, Stress, Anxiety
- Keywords
- virtual reality, medical device
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Istituto Oncologico Veneto IRCCSUniversity, hospital or other
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Device: REALICAREALICA® 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. |
| Control group | Active comparator | Other: Clinical PracticeControl group will be treated according to clinical practice. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REALICAREALICA® 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 | Virtual reality |
| Clinical PracticePatients in the Control group will receive topical anesthesia, without application of virtual viewer. | Other | Control group |
Primary outcome
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
6 secondary outcomes
Intensity of pain
Time frame: Through study completion, an average of 1 year
Intensity of pain
Time frame: Through study completion, an average of 1 year
Pain levels
Time frame: Through study completion, an average of 1 year
Pain levels
Time frame: Through study completion, an average of 1 year
Feasibility and acceptability of REALICA®
Time frame: Through study completion, an average of 1 year
Patient Satisfaction Questionnaire
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Results publication: PubMed 37921714Deniz Dogan S, Yurtseven S, Arslan S. The Effect of Preoperative Pain, Fear, and Anxiety on Postoperative Pain in Urological Surgery Patients: A Descriptive and Correlational Study. J Perianesth Nurs. 2024 Apr;39(2):202-206. doi: 10.1016/j.jopan.2023.07.013. Epub 2023 Nov 3.
- Results publication: PubMed 40070544Jiao D. Advancing personalized digital therapeutics: integrating music therapy, brainwave entrainment methods, and AI-driven biofeedback. Front Digit Health. 2025 Feb 25;7:1552396. doi: 10.3389/fdgth.2025.1552396. eCollection 2025.
- Results publication: PubMed 38028428Terzulli C, Chauvin C, Champagnol Di-Liberti C, Faisan S, Goffin L, Gianesini C, Graff D, Dufour A, Laroche E, Salvat E, Poisbeau P. Virtual reality hypnosis diminishes experimental cold pain and alters autonomic responses. Front Pain Res (Lausanne). 2023 Nov 2;4:1237090. doi: 10.3389/fpain.2023.1237090. eCollection 2023.
- Results publication: PubMed 37589975Rizzo MG Jr, Costello JP 2nd, Luxenburg D, Cohen JL, Alberti N, Kaplan LD. Augmented Reality for Perioperative Anxiety in Patients Undergoing Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2329310. doi: 10.1001/jamanetworkopen.2023.29310.
- Results publication: PubMed 32423641Ahmad M, Bani Mohammad E, Anshasi HA. Virtual Reality Technology for Pain and Anxiety Management among Patients with Cancer: A Systematic Review. Pain Manag Nurs. 2020 Dec;21(6):601-607. doi: 10.1016/j.pmn.2020.04.002. Epub 2020 May 15.
- Results publication: PubMed 31456530Georgescu R, Fodor LA, Dobrean A, Cristea IA. Psychological interventions using virtual reality for pain associated with medical procedures: a systematic review and meta-analysis. Psychol Med. 2020 Aug;50(11):1795-1807. doi: 10.1017/S0033291719001855. Epub 2019 Aug 28.
- Results publication: PubMed 35904872Terzulli C, Melchior M, Goffin L, Faisan S, Gianesini C, Graff D, Dufour A, Laroche E, Chauvin C, Poisbeau P. Effect of Virtual Reality Hypnosis on Pain Threshold and Neurophysiological and Autonomic Biomarkers in Healthy Volunteers: Prospective Randomized Crossover Study. J Med Internet Res. 2022 Jul 29;24(7):e33255. doi: 10.2196/33255.
- Results publication: PubMed 38355563Teh JJ, Pascoe DJ, Hafeji S, Parchure R, Koczoski A, Rimmer MP, Khan KS, Al Wattar BH. Efficacy of virtual reality for pain relief in medical procedures: a systematic review and meta-analysis. BMC Med. 2024 Feb 14;22(1):64. doi: 10.1186/s12916-024-03266-6.
- Results publication: PubMed 36048232Ketsuwan C, Matang W, Ratanapornsompong W, Sangkum P, Phengsalae Y, Kongchareonsombat W, Jongwannasiri M. Prospective randomized controlled trial to evaluate effectiveness of virtual reality to decrease anxiety in office-based flexible cystoscopy patients. World J Urol. 2022 Oct;40(10):2575-2581. doi: 10.1007/s00345-022-04142-9. Epub 2022 Sep 1.
- Results publication: PubMed 34834565Luczak M, Nowak L, Chorbinska J, Galik K, Kielb P, Laszkiewicz J, Tukiendorf A, Koscielska-Kasprzak K, Malkiewicz B, Zdrojowy R, Szydelko T, Krajewski W. Influence of Virtual Reality Devices on Pain and Anxiety in Patients Undergoing Cystoscopy Performed under Local Anaesthesia. J Pers Med. 2021 Nov 16;11(11):1214. doi: 10.3390/jpm11111214.
- Results publication: PubMed 39547279Geretto P, De Cillis S, Candela L, Germain T, Vienney N, Felber M, Phe V. Integrating a Virtual Reality Mask in Functional Urological Surgeries Under Local Anesthesia: A Prospective Cohort Study on Utility and Satisfaction. Urology. 2025 Feb;196:93-99. doi: 10.1016/j.urology.2024.11.007. Epub 2024 Nov 14.
- Results publication: PubMed 39848858Perucchini F, Baumeister P, Fankhauser CD. Beyond Anesthesia: A Mini Review of Virtual Reality as an Adjunct in Urological Procedures. Eur Urol Focus. 2025 May;11(3):511-514. doi: 10.1016/j.euf.2025.01.007. Epub 2025 Jan 22.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Urologic Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REALICA and Clinical Practice in people with Urologic Diseases and Prostate Biopsy, run by Istituto Oncologico Veneto IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Amodeo, MD (0423-421321, antonio.amodeo@iov.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety reduction (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07338292, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.