Use of a Virtual Reality Headset During Prostate Biopsy Under Local Anesthesia to Improve the Patient's Experience
Use of a Virtual Reality Visor (REALICA®) as an Supplementary Tool to Local Anesthesia in Patients Undergoing Prostate Biopsy: A Randomized Clinical Trial
This is a post-market clinical investigation evaluating the effect of immersive virtual reality (VR) as an adjunct to standard local anesthesia during transperineal prostate biopsy.
Transperineal prostate biopsy under local anesthesia is commonly associated with patient anxiety, procedural discomfort, and vasovagal reactions, which may negatively impact patient experience and procedural tolerability. Non-pharmacological distraction techniques such as immersive VR have shown potential to reduce perceived pain and anxiety during short, invasive medical procedures by modulating cognitive attention and emotional response.
This study investigates whether the use of an immersive VR headset, added to standard local anesthesia, can reduce peri-procedural anxiety and pain compared to standard care alone. The intervention is designed to provide continuous audiovisual immersive distraction starting shortly before the procedure and continuing throughout the biopsy, without altering standard clinical workflow or increasing procedural invasiveness.
This is a randomized, controlled, parallel-group, 1:1 superiority trial with a single-blind (assessor-blinded) design. Participants undergoing transperineal prostate biopsy under local anesthesia will be randomly assigned to one of two groups: standard local anesthesia alone (control arm) or standard local anesthesia plus immersive VR (experimental arm).
The primary objective is to evaluate whether immersive VR reduces peri-procedural anxiety and pain compared with standard local anesthesia alone. Secondary objectives may include evaluation of patient satisfaction, tolerability of the VR intervention, and incidence of vasovagal reactions or procedural interruptions.
The study aims to generate evidence on the feasibility and clinical benefit of integrating immersive VR as a non-pharmacological supportive tool in urological diagnostic procedures.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Italy
-
Milan, Italy, Italia, 20132
- IRCCS Ospedale San Raffaele
-
Contacto:
- Simone Scuderi
- Número de teléfono: +39 02 2643 6922
- Correo electrónico: scuderi.simone@hsr.it
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- The participant provides written informed consent for the trial
- Male participants who are at least 18 years of age on the day of signing informed consent
- Men undergoing transperineal prostate biopsy under local anesthesia
Exclusion Criteria:
- Visual or hearing impairment that would prevent effective use of the virtual reality device
- History of epilepsy or seizure disorders
- Severe motion sickness or known susceptibility to cybersickness
- Severe psychiatric disorders that, in the investigator's judgment, could interfere with study participation or outcome assessment
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Arm A (Control)- Transperineal Prostate Biopsy under Local Anesthesia
Participants undergo transperineal prostate biopsy performed under standard clinical practice using local anesthesia.
Local anesthetic is administered according to institutional protocol prior to the procedure.
No additional interventions or supportive devices are used in this arm.
Patients receive routine peri-procedural monitoring and care as per standard of care.
|
Transperineal prostate biopsy performed under standard clinical practice using local anesthesia administered according to institutional protocol.
No additional supportive or experimental interventions are applied.
|
|
Experimental: Arm B (Experimental)- Local anesthesia + immersive VR headset
Participants undergo transperineal prostate biopsy performed under standard clinical practice using local anesthesia, with the addition of an immersive virtual reality (VR) headset as a supportive intervention.
The VR device is applied approximately 3-5 minutes before the start of the procedure and is worn continuously throughout the biopsy.
The VR experience is used as a non-pharmacological distraction tool intended to reduce peri-procedural anxiety and pain.
|
Transperineal prostate biopsy performed under standard local anesthesia with the addition of an immersive virtual reality (VR) headset used as a non-pharmacological distraction tool.
The VR device is applied approximately 3-5 minutes before the start of the procedure and worn continuously throughout the biopsy.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Procedural Pain Intensity
Periodo de tiempo: Immediately after completion of the biopsy procedure
|
Pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain)
|
Immediately after completion of the biopsy procedure
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Procedural anxiety
Periodo de tiempo: Immediately post-procedure
|
Assessed using the State-Trait Anxiety Inventory Form Y-1 (STAI-Y1).
The STAI-Y1 total score ranges from 20 to 80, with higher scores indicating greater anxiety
|
Immediately post-procedure
|
|
Decision regret
Periodo de tiempo: 1 month (Day 30 ± 5 days) after the procedure
|
Assessed using the validated Decision Regret Scale (DRS).
The Decision Regret Scale is a 5-item questionnaire assessing regret following a healthcare decision.
Scores range from 0 to 100, with higher scores indicating greater decision regret.
|
1 month (Day 30 ± 5 days) after the procedure
|
|
Urinary incontinence
Periodo de tiempo: Baseline and 1 month (Day 30 ± 5 days) after the procedure
|
Assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF).
Total scores range from 0 to 21, with higher scores indicating greater severity of urinary incontinence.
|
Baseline and 1 month (Day 30 ± 5 days) after the procedure
|
|
Lower urinary tract symptoms
Periodo de tiempo: Baseline and 1 month (Day 30 ± 5 days) after the procedure
|
Assessed using the International Prostate Symptom Score (IPSS).
Total scores range from 0 to 35, with higher scores indicating greater severity of lower urinary tract symptoms.
|
Baseline and 1 month (Day 30 ± 5 days) after the procedure
|
|
Sexual function
Periodo de tiempo: Baseline and 1 month (Day 30 ± 5 days) after the procedure
|
Assessed using the International Index of Erectile Function (IIEF).
The IIEF is a validated 15-item questionnaire assessing male sexual function.
Total scores range from 5 to 75, with higher scores indicating better sexual function.
|
Baseline and 1 month (Day 30 ± 5 days) after the procedure
|
|
Health-related quality of life
Periodo de tiempo: Baseline and 1 month (Day 30 ± 5 days) after the procedure
|
Assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ).
The EORTC QLQ is a validated questionnaire assessing health-related quality of life.
Scores are transformed into a 0 to 100 scale.
For functional scales and global health status, higher scores indicate better quality of life, whereas for symptom scales, higher scores indicate greater symptom burden.
|
Baseline and 1 month (Day 30 ± 5 days) after the procedure
|
|
Depressive symptoms
Periodo de tiempo: Baseline and 1 month (Day 30 ± 5 days) after the procedure
|
Assessed using the Patient Health Questionnaire-9 (PHQ-9).
The PHQ-9 is a 9-item questionnaire assessing depressive symptoms.
Total scores range from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
|
Baseline and 1 month (Day 30 ± 5 days) after the procedure
|
|
Post-procedural complications
Periodo de tiempo: During the procedure and up to 30 days after the procedure
|
Collection of all reported complications related to the biopsy procedure, including vasovagal reactions and other adverse events.
|
During the procedure and up to 30 days after the procedure
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- VR-biopsy
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .