Feasibility of Virtual Reality Assistance in Prostate Biopsy Under Local Anesthesia.
Not Applicable
Not yet recruiting
- Conditions
- Prostate Cancer
- Interventions
- Device: Use of Virtual Reality Assistance during prostate biopsies
- Registration Number
- NCT06274684
- Lead Sponsor
- University Hospital, Geneva
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual Reality assistance group Use of Virtual Reality Assistance during prostate biopsies Patient receiving VR headset during prostate biopsies
- Primary Outcome Measures
Name Time Method Anxiety level On the day of the biopsies (before the procedure) and one day after procedure State-Trait Anxiety Inventory (STAI) validated questionnaires
- Secondary Outcome Measures
Name Time Method Biopsies complications In the 30 days following prostate biopsies Anxiety level of the surgeon One day after procedure Short-Form State-Trait Anxiety Inventory validated questionnaires