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Trial Title:
Feasibility of Virtual Reality Assistance in Prostate Biopsy Under Local Anesthesia.
NCT ID:
NCT06274684
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Virtual Reality
VR
Anxiety
Prostate biopsies
Transperineal biopsies
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Use of Virtual Reality Assistance during prostate biopsies
Description:
Patient will be equipped with VR headset providing a immersive experience during prostate
biopsies
Arm group label:
Virtual Reality assistance group
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.
Criteria for eligibility:
Criteria:
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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
February 19, 2024
Completion date:
July 1, 2025
Lead sponsor:
Agency:
University Hospital, Geneva
Agency class:
Other
Source:
University Hospital, Geneva
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06274684
