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

February 23, 2024 updated by: Sylvain Vanoli, University Hospital, Geneva

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Virtual Reality assistance group
Patient receiving VR headset during prostate biopsies
Device: Use of Virtual Reality Assistance during prostate biopsies
Patient will be equipped with VR headset providing a immersive experience during prostate biopsies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety level
Time Frame: On the day of the biopsies (before the procedure) and one day after procedure
State-Trait Anxiety Inventory (STAI) validated questionnaires
On the day of the biopsies (before the procedure) and one day after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biopsies complications
Time Frame: In the 30 days following prostate biopsies
In the 30 days following prostate biopsies
Anxiety level of the surgeon
Time Frame: One day after procedure
Short-Form State-Trait Anxiety Inventory validated questionnaires
One day after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 19, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 20, 2024

First Posted (Actual)

February 23, 2024

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-01100

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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