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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality assistance group | Experimental | Patient receiving VR headset during prostate biopsies |
|
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of Virtual Reality Assistance during prostate biopsies | Device | Patient will be equipped with VR headset providing a immersive experience during prostate biopsies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety level | State-Trait Anxiety Inventory (STAI) validated questionnaires | On the day of the biopsies (before the procedure) and one day after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety level of the surgeon | Short-Form State-Trait Anxiety Inventory validated questionnaires | One day after procedure |
| Biopsies complications | In the 30 days following prostate biopsies |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001523 | Mental Disorders |