Clinical trial · Interventional
Feasibility of Virtual Reality Assistance in Prostate Biopsy Under Local Anesthesia.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to test the impact of Virtual Reality (VR) assistance for anxiety management of patients undergoing prostate biopsies in local anaesthesia. The main question it aims to answer: \- Is there a significant decrease on anxiety level thanks to VR-assistance? Participants will be equipped with VR headset providing an immersive visual experience accompanied with a hypnoses oriented audio during the entire procedure. Researchers will compare standardised anxiety scores with a control group.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Use of Virtual Reality Assistance during prostate biopsies | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Virtual Reality assistance group
- description
- Patient receiving VR headset during prostate biopsies
- interventionNames
- Device: Use of Virtual Reality Assistance during prostate biopsies
- type
- NO_INTERVENTION
- label
- Control group
Primary outcomes (1)
- measure
- Anxiety level
- timeFrame
- On the day of the biopsies (before the procedure) and one day after procedure
- description
- State-Trait Anxiety Inventory (STAI) validated questionnaires
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Indication for prostate biopsies * Informed consent Exclusion Criteria: * Local anaesthesia contra-indication (allergy) * Claustrophobia * Major cognitive impairment and impossibility of answering the standardised questionnaires
References
Publications (0)
Data not yet available