Prostate CancerNCT06274684
Feasibility of Virtual Reality Assistance in Prostate Biopsy Under Local Anesthesia.
A study testing Use of Virtual Reality Assistance during prostate biopsies in people with Prostate Cancer, run by University Hospital, Geneva.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Use of Virtual Reality Assistance during prostate biopsies
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 19 Feb 2024to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for prostate biopsies
- Informed consent
Who cannot join
- Local anaesthesia contra-indication (allergy)
- Claustrophobia
- Major cognitive impairment and impossibility of answering the standardised questionnaires
About this study
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.
- Conditions
- Prostate Cancer
- Being tested
- Use of Virtual Reality Assistance during prostate biopsies
- Keywords
- Virtual Reality, VR, Anxiety, Prostate biopsies, Transperineal biopsies
- Medical subject headings
- Prostatic Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Virtual Reality Assistance during prostate biopsiesDevice
Patient will be equipped with VR headset providing a immersive experience during prostate biopsies
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality assistance group | Experimental | Patient receiving VR headset during prostate biopsies Receives: Device: Use of Virtual Reality Assistance during prostate biopsies |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level
State-Trait Anxiety Inventory (STAI) validated questionnaires
Measured: On the day of the biopsies (before the procedure) and one day after procedure
Secondary outcomes (2)
Anxiety level of the surgeon
Short-Form State-Trait Anxiety Inventory validated questionnaires
Measured: One day after procedure
Biopsies complications
Measured: In the 30 days following prostate biopsies
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start19 Feb 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvain Vanoli, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274684
- Sponsor's protocol ID
- 2023-01100
- Other IDs
- 2023
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Virtual Reality Assistance in Prostate Biopsy Under Local Anesthesia.
- ClinicalTrials.gov ID
- NCT06274684
- Acronym / sponsor ID
- 2023-01100
- Conditions
- Prostate Cancer
- Keywords
- Virtual Reality, VR, Anxiety, Prostate biopsies, Transperineal biopsies
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 19 Feb 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality assistance group | Experimental | Device: Use of Virtual Reality Assistance during prostate biopsiesPatient receiving VR headset during prostate biopsies |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for prostate biopsies
- Informed consent
Key exclusion criteria (3 listed)
- Local anaesthesia contra-indication (allergy)
- Claustrophobia
- Major cognitive impairment and impossibility of answering the standardised questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Virtual Reality Assistance during prostate biopsiesPatient will be equipped with VR headset providing a immersive experience during prostate biopsies | Device | Virtual Reality assistance group |
Primary outcome
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
2 secondary outcomes
Anxiety level of the surgeon
Time frame: One day after procedure
Biopsies complications
Time frame: In the 30 days following prostate biopsies
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Virtual Reality Assistance during prostate biopsies in people with Prostate Cancer, run by University Hospital, Geneva.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety level (time frame: On the day of the biopsies (before the procedure) and one day after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.