NCT06274684

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable prostate-cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

February 19, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

February 13, 2024

Last Update Submit

February 23, 2024

Conditions

Prostate Cancer

Keywords

Virtual RealityVRAnxietyProstate biopsiesTransperineal biopsies

Outcome Measures

Primary Outcomes (1)

  • Anxiety level

    State-Trait Anxiety Inventory (STAI) validated questionnaires

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

Secondary Outcomes (2)

  • Anxiety level of the surgeon

    One day after procedure

  • Biopsies complications

    In the 30 days following prostate biopsies

Study Arms (2)

Virtual Reality assistance group

EXPERIMENTAL

Patient receiving VR headset during prostate biopsies

Device: Use of Virtual Reality Assistance during prostate biopsies

Control group

NO INTERVENTION

Interventions

Use of Virtual Reality Assistance during prostate biopsiesDEVICE

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

Virtual Reality assistance group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for prostate biopsies
  • Informed consent

You may not qualify if:

  • Local anaesthesia contra-indication (allergy)
  • Claustrophobia
  • Major cognitive impairment and impossibility of answering the standardised questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic NeoplasmsAnxiety Disorders

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 13, 2024

First Posted

February 23, 2024

Study Start

February 19, 2024

Primary Completion

May 1, 2025

Study Completion

July 1, 2025

Last Updated

February 28, 2024

Record last verified: 2024-02