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Use of a Virtual Reality Headset During Prostate Biopsy Under Local Anesthesia to Improve the Patient's Experience

8 juli 2026 bijgewerkt door: Prof. Alberto Briganti, IRCCS San Raffaele

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Italië
    • Italy
      • Milan, Italy, Italië, 20132
        • IRCCS Ospedale San Raffaele
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Procedure: Standard Local Anesthesia
Transperineal prostate biopsy performed under standard clinical practice using local anesthesia administered according to institutional protocol. No additional supportive or experimental interventions are applied.
Experimenteel: 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.
Apparaat: Immersive Virtual Reality (VR) Headset
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Procedural Pain Intensity
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Procedural anxiety
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

IRCCS San Raffaele

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 oktober 2026

Studie voltooiing (Geschat)

1 oktober 2028

Studieregistratiedata

Eerst ingediend

30 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

8 juli 2026

Eerst geplaatst (Werkelijk)

14 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

8 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • VR-biopsy

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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