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

N/ANot Yet RecruitingNCT06274684

University Hospital, Geneva100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Prostate Cancer

Interventions

Use of Virtual Reality Assistance during prostate biopsiesDEVICE

Patient will be equipped with VR headset providing a immersive experience during prostate biopsies

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Anxiety level

State-Trait Anxiety Inventory (STAI) validated questionnaires

Time frame: On the day of the biopsies (before the procedure) and one day after procedure

Secondary Outcomes

Anxiety level of the surgeon

Short-Form State-Trait Anxiety Inventory validated questionnaires

Time frame: One day after procedure

Biopsies complications

Time frame: In the 30 days following prostate biopsies

Data from ClinicalTrials.gov

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