Feasibility of Virtual Reality Assistance in Prostate Biopsy Under Local Anesthesia.

University Hospitals (UH)

Status: Not yet enrolling

Conditions: Prostate Cancer

Treatments: Device: Use of Virtual Reality Assistance during prostate biopsies

Study type: Interventional

Funder types: Other

Identifiers

NCT06274684

2023-01100

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Virtual Reality assistance group

Experimental group

Description:

Patient receiving VR headset during prostate biopsies

Treatment:

Device: Use of Virtual Reality Assistance during prostate biopsies

Control group

No Intervention group