VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures

NCT ID: NCT07338292

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-17
• Study Completion Date: 2026-10-31

Brief 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. 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.

Conditions

Urologic Diseases; Prostate Biopsy; Flexible Cystoscopy; Circumcision; Stress; Anxiety; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

REALICA

Intervention Type: DEVICE

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.

Control group

Control group will be treated according to clinical practice.

Group Type: ACTIVE_COMPARATOR

Clinical Practice

Intervention Type: OTHER

Patients in the Control group will receive topical anesthesia, without application of virtual viewer.

Interventions

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.

Intervention Type: DEVICE

Clinical Practice

Patients in the Control group will receive topical anesthesia, without application of virtual viewer.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Oncologico Veneto IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Oncologico Veneto IRCCS

Padua, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Antonio Amodeo, MD

Role: CONTACT

antonio.amodeo@iov.veneto.it

0423-421321

Gian Luca De Salvo, MD

Role: CONTACT

clinical.trial@iov.veneto.it

0498215704

Facility Contacts

Antonio Amodeo, MD

Role: primary

antonio.amodeo@iov.veneto.it

0423 421321 ext. +39

Gian Luca De Salvo, MD

Role: backup

clinical.trial@iov.veneto.it

049 8215710 ext. +39

References

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.

Reference Type: RESULT

PMID: 37921714 (View on PubMed)

Jiao 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.

Reference Type: RESULT

PMID: 40070544 (View on PubMed)

Terzulli 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.

Reference Type: RESULT

PMID: 38028428 (View on PubMed)

Rizzo 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.

Reference Type: RESULT

PMID: 37589975 (View on PubMed)

Ahmad 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.

Reference Type: RESULT

PMID: 32423641 (View on PubMed)

Georgescu 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.

Reference Type: RESULT

PMID: 31456530 (View on PubMed)

Terzulli 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.

Reference Type: RESULT

PMID: 35904872 (View on PubMed)

Teh 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.

Reference Type: RESULT

PMID: 38355563 (View on PubMed)

Ketsuwan 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.

Reference Type: RESULT

PMID: 36048232 (View on PubMed)

Luczak 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.

Reference Type: RESULT

PMID: 34834565 (View on PubMed)

Geretto 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.

Reference Type: RESULT

PMID: 39547279 (View on PubMed)

Perucchini 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.

Reference Type: RESULT

PMID: 39848858 (View on PubMed)

Candela 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.

Reference Type: RESULT

PMID: 36796544 (View on PubMed)

Carannante 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.

Reference Type: RESULT

PMID: 39470831 (View on PubMed)

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Other Identifiers

IOV-UD-01-2025-VIPER_URO

Identifier Type: -

Identifier Source: org_study_id