VIrtual Reality Induced Pain and anxiEty Relief in Outpatient UROlogical Procedures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorIstituto Oncologico Veneto IRCCS
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
REALICA
DeviceREALICA® 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 Practice
Other interventionPatients in the Control group will receive topical anesthesia, without application of virtual viewer.
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Virtual realityExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention
Trial outcomes
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
Time frame
Through study completion, an average of 1 yearSecondary outcomes
1
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
Time frame
Through study completion, an average of 1 year2
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.
Time frame
Through study completion, an average of 1 year3
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
Time frame
Through study completion, an average of 1 year4
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.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov