VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures

Istituto Oncologico Veneto IRCCS

Status: Enrolling

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

Treatments: Device: REALICA; Other: Clinical Practice

Study type: Interventional

Funder types: Other

Identifiers

NCT07338292

IOV-UD-01-2025-VIPER_URO

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Virtual reality

Experimental group

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.

Treatment:

Device: REALICA

Control group

Active Comparator group

Description:

Control group will be treated according to clinical practice.

Treatment:

Other: Clinical Practice