Interventional ImagingIRVARINCT05966402
Evaluation of Immersion in Virtual Reality in the Management of Anxiety, Then Pain, of Patients in Interventional Imaging.
A study testing Virtual Reality in people with Interventional Imaging, run by University Hospital, Caen at 1 site in France.
Trial summary
Investigators propose to use static VR scenarios, adapted to the patient's preferences (sea, mountain, countryside…) to immerse them in an emotionally positive environment. The objective is to reduce the anxiety and pain associated with IR acts in the operating room. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Interventional Imaging
- What is being tested?
- Virtual Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2021to 19 Jul 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (18-80 years old) with an indication for performing one of the following interventional radiology procedures, according to HAS recommendations: Liver biopsy puncture, embolization of varicoceles, embolization of pelvic varices, embolization of uterine fibroids, Hepatic arterial chemoembolization for hepatocellular carcinoma, radioembolization.
Who cannot join
- Pregnant or breastfeeding women.
- Minor or age > 80 years.
- People suffering from psychiatric pathologies, chronic depressive syndrome or chronic anxiety disorder.
- People with a high risk of motion sickness during virtual reality immersion (MMSQ and VIMSSQ > 80th percentile).
Trial locations and contacts
1 site in 1 country.
About this study
Investigators propose to use static VR scenarios, adapted to the patient's preferences (sea, mountain, countryside…) to immerse them in an emotionally positive environment. The objective is to reduce the anxiety and pain associated with IR acts in the operating room.
Hypothesis tested:
The use of the 3D immersion of an oculus rift DK2 virtual reality headset during an interventional radiology intervention would reduce the anxiety felt by patients by 25%, evaluated by the STAI YB scale. The correlation between the STAI YB and the APAIS and HAD scales will also be tested.
- Conditions
- Interventional Imaging
- Being tested
- Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
Immersion in Virtual Reality
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Not described Receives: Other: Virtual Reality |
| standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety measured with STAI Y-B
For the main objective, the STAI Y-B will be used to assess reactive anxiety as close as possible to the interventional gesture, i.e. just after it.
Measured: once (as close as possible to the interventional gesture, i.e. just after it.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start17 May 2021
- Primary completion19 Jul 2023
- Study completion19 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interventional ImagingStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966402
- Sponsor's protocol ID
- 19-197
- Acronym
- IRVARI
- Status last verified
- Jul 2023
- First submitted
- 20 Jul 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immersion in Virtual Reality in the Management of Anxiety, Then Pain, of Patients in Interventional Imaging.
- ClinicalTrials.gov ID
- NCT05966402
- Acronym / sponsor ID
- IRVARI / 19-197
- Conditions
- Interventional Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 28 Jul 2023 (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.
Investigators propose to use static VR scenarios, adapted to the patient's preferences (sea, mountain, countryside…) to immerse them in an emotionally positive environment. The objective is to reduce the anxiety and pain associated with IR acts in the operating room.
Hypothesis tested:
The use of the 3D immersion of an oculus rift DK2 virtual reality headset during an interventional radiology intervention would reduce the anxiety felt by patients by 25%, evaluated by the STAI YB scale. The correlation between the STAI YB and the APAIS and HAD scales will also be tested.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Other: Virtual Reality |
| standard care | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients (18-80 years old) with an indication for performing one of the following interventional radiology procedures, according to HAS recommendations: Liver biopsy puncture, embolization of varicoceles, embolization of pelvic varices, embolization of uterine fibroids, Hepatic arterial chemoembolization for hepatocellular carcinoma, radioembolization.
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding women.
- Minor or age > 80 years.
- People suffering from psychiatric pathologies, chronic depressive syndrome or chronic anxiety disorder.
- People with a high risk of motion sickness during virtual reality immersion (MMSQ and VIMSSQ > 80th percentile).
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 |
|---|---|---|
| Virtual RealityImmersion in Virtual Reality | Other | Virtual Reality |
Primary outcome
anxiety measured with STAI Y-B
Time frame: once (as close as possible to the interventional gesture, i.e. just after it.)
For the main objective, the STAI Y-B will be used to assess reactive anxiety as close as possible to the interventional gesture, i.e. just after it.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Interventional Imaging
Not yet recruitingPhase 1
A Project Assessing the Safety and Feasibility of Using Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Ovarian Cancer During Surgical Procedures
Cancer, Chemotherapy
Enrolling by invitationObservational study
Renal Structural and Functional Alterations Following Repeated Ureteroscopic Procedures: An Exploratory Multimodal Imaging Study
Urolithiasis, Intrarenal Pressure
Recruiting
Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures
Atrial Fibrillation, Atrial Flutter
RecruitingObservational study
Observational Study of the LambdaGuide System for Measurement of Observable Genitourinary Anatomy During Cystoscopic Procedures in Men
Genitourinary Anatomy
Active, not recruiting
A Study of Near-Infrared Fluorescence Imaging With ICG During Reconstructive Gynecologic Surgery
Gynecologic Surgery
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality in people with Interventional Imaging, run by University Hospital, Caen at 1 site in France.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 measured with STAI Y-B (time frame: once (as close as possible to the interventional gesture, i.e. just after it.)). 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 Jul 2023.