VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures

NCT07338292 | Recruiting DMC

• 1 other identifier: IOV-UD-01-2025-VIPER_URO
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

virtual reality; medical device

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion, an average of 1 year

Secondary Outcomes (6)

• Intensity of pain

  Through study completion, an average of 1 year

• Intensity of pain

  Through study completion, an average of 1 year

• Pain levels

  Through study completion, an average of 1 year

• Pain levels

  Through study completion, an average of 1 year

• Feasibility and acceptability of REALICA®

  Through study completion, an average of 1 year

Study Arms (2)

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.

Device: REALICA

Control group

ACTIVE COMPARATOR

Control group will be treated according to clinical practice.

Other: Clinical Practice

Interventions

REALICA 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.

Virtual reality

Clinical Practice OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Oncologico Veneto IRCCS: lead

Study Sites (1)

Istituto Oncologico Veneto IRCCS

Padua, 35128, Italy

RECRUITING

Related Publications (14)

• 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.

  PMID: 37921714 RESULT

• 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.

  PMID: 40070544 RESULT

• 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.

  PMID: 38028428 RESULT

• 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.

  PMID: 37589975 RESULT

• 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.

  PMID: 32423641 RESULT

• 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.

  PMID: 31456530 RESULT

• 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.

  PMID: 35904872 RESULT

• 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.

  PMID: 38355563 RESULT

• 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.

  PMID: 36048232 RESULT

• 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.

  PMID: 34834565 RESULT

• 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.

  PMID: 39547279 RESULT

• 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.

  PMID: 39848858 RESULT

• 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.

  PMID: 36796544 RESULT

• 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.

  PMID: 39470831 RESULT

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MeSH Terms

Conditions

Urologic Diseases; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Antonio Amodeo, MD

CONTACT

0423-421321; antonio.amodeo@iov.veneto.it

Gian Luca De Salvo, MD

CONTACT

0498215704; clinical.trial@iov.veneto.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Control group will be treated according to clinical practice.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 13, 2026
• Study Start: December 17, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

IT (1)