Prostate Cancer
Conditions
Keywords
Virtual Reality, VR, Anxiety, Prostate biopsies, Transperineal biopsies
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.
Interventions
DEVICEUse of Virtual Reality Assistance during prostate biopsies
Patient will be equipped with VR headset providing a immersive experience during prostate biopsies
Sponsors
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety level | On the day of the biopsies (before the procedure) and one day after procedure | State-Trait Anxiety Inventory (STAI) validated questionnaires |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety level of the surgeon | One day after procedure | Short-Form State-Trait Anxiety Inventory validated questionnaires |
| Biopsies complications | In the 30 days following prostate biopsies | — |
Outcome results
None listed