ClaustrophobiaCLAUSTROVRNCT04754958
Virtual Reality to Alleviate Claustrophobia During MRI
A study testing Immersion in virtual reality using Nordic Neurolab(™) Visual System in people with Claustrophobia, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.
Trial summary
This study evaluates if our Virtual Reality (VR) simulation inside the MRI efficiently alleviates symptoms of claustrophobia for patients during the MRI examination. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Claustrophobia
- What is being tested?
- Immersion in virtual reality using Nordic Neurolab(™) Visual System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Jul 2021to 28 Feb 2024
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- indicating suffering from claustrophobia
- Be aged between 18 and 40 year-old
- Being able to give consent
- Being able to understand and speak French or English
- Being MRI-compatible
Who cannot join
- Epilepsy or illnesses affecting the brain, such as HIV, Lyme disease or meningitis
- Psychiatric disorders, such as schizophrenia, autism, obsessive compulsive disorder.
- History of 1 year or more of addiction to drugs such as cannabis, alcohol, cocain, heroine, LSD.
- Taking sleeping pills or anti-anxiety medication before the exam
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Benefit of Virtual Reality to Alleviate Claustrophobia During MRI Clinical Procedure
This study evaluates if our Virtual Reality (VR) simulation inside the MRI efficiently alleviates symptoms of claustrophobia for patients during the MRI examination.
Read the detailed description
Anxiety of claustrophobic patients during MRI scan leads to movements of patients (which cause imaging artefacts), interruptions or even abortions of imaging scans, eventually requiring to reschedule the examination. Improving these symptoms by creating a VR experiences adapted to the physical constraints of the MRI environment, such as "disappearing the scanner", not only improves the subjective experience of the participant, but has immediate impacts the time spent on the examination, on personnel costs, and resource availability (scanner time).
This study aims at comparing claustrophobic patients in an A|B group design with or without VR intervention. Primary outcomes include subjective reports from patients (Acceptability and Demand) and practitioners (Implementation, Practicality, Adaptation, Integration, Expansion). Secondary outcomes include scanning efficacy based e.g. on the imaging quality, number of times a scan is interrupted by the user and the total duration of a scan. Another non-claustrophobic patients' group will be tested for for obtaining feedback on the general benefit of VR immersion on patients' experience.
- Conditions
- Claustrophobia
- Being tested
- Immersion in virtual reality using Nordic Neurolab(™) Visual System
- Medical subject headings
- Claustrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersion in virtual reality using Nordic Neurolab(™) Visual SystemDevice
In addition to the standard MRI procedure, the VR intervention group will be looking at stereoscopic computer generated images through a pair of head-coil-mounted googles (Nordic Neurolab ™ Visual System). Two markers (color balls) will be fixed on their knees to capture their movement (camera tracking from the outside of the MRI room). The VR scenario will consist in showing a replication of the actual MRI examination room, as seen from the point of view of the participant lying on the MRI bed, but without the MRI tunnel. Participant can see themselves in the large room (a simplified gender-matched avatar), and an entertaining video can be displayed.
| Study group | Role | What they receive |
|---|---|---|
| VR | Experimental | In addition to standard care during MRI scan, patient receives VR intervention. Receives: Device: Immersion in virtual reality using Nordic Neurolab(™) Visual System |
| No VR | No intervention | Standard of care during MRI scan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level
Questionnaire on anxiety during scan (9 items)
Measured: through study completion, an average of one year
Interruption
Record of interruption due to claustrophobia during MRI scan
Measured: through study completion, an average of one year
Secondary outcomes (1)
MRI Image quality
Evaluation of MRI image quality for medical care
Measured: through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start20 Jul 2021
- Primary completion1 Dec 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClaustrophobiaStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Invervention group / no intervention group (standard of care)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ecole Polytechnique Fédérale de Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Principal investigator, Olaf Blanke, Ecole Polytechnique Fédérale de Lausanne
- Investigators
- Olaf Blanke, Principal investigator, Ecole Polytechnique Fédéralede Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754958
- Sponsor's protocol ID
- VRMRI_LNCO2021
- Acronym
- CLAUSTROVR
- Status last verified
- Aug 2024
- First submitted
- 9 Feb 2021
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Benefit of Virtual Reality to Alleviate Claustrophobia During MRI Clinical Procedure
- ClinicalTrials.gov ID
- NCT04754958
- Acronym / sponsor ID
- CLAUSTROVR / VRMRI_LNCO2021
- Conditions
- Claustrophobia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ecole Polytechnique Fédérale de LausanneUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 15 Feb 2021 (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.
This study evaluates if our Virtual Reality (VR) simulation inside the MRI efficiently alleviates symptoms of claustrophobia for patients during the MRI examination.
Detailed description
Anxiety of claustrophobic patients during MRI scan leads to movements of patients (which cause imaging artefacts), interruptions or even abortions of imaging scans, eventually requiring to reschedule the examination. Improving these symptoms by creating a VR experiences adapted to the physical constraints of the MRI environment, such as "disappearing the scanner", not only improves the subjective experience of the participant, but has immediate impacts the time spent on the examination, on personnel costs, and resource availability (scanner time).
This study aims at comparing claustrophobic patients in an A|B group design with or without VR intervention. Primary outcomes include subjective reports from patients (Acceptability and Demand) and practitioners (Implementation, Practicality, Adaptation, Integration, Expansion). Secondary outcomes include scanning efficacy based e.g. on the imaging quality, number of times a scan is interrupted by the user and the total duration of a scan. Another non-claustrophobic patients' group will be tested for for obtaining feedback on the general benefit of VR immersion on patients' experience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Invervention group / no intervention group (standard of care)
| Arm | Type | Receives |
|---|---|---|
| VR | Experimental | Device: Immersion in virtual reality using Nordic Neurolab(™) Visual SystemIn addition to standard care during MRI scan, patient receives VR intervention. |
| No VR | No intervention | –Standard of care during MRI scan. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- indicating suffering from claustrophobia
- Be aged between 18 and 40 year-old
- Being able to give consent
- Being able to understand and speak French or English
- Being MRI-compatible
Key exclusion criteria (4 listed)
- Epilepsy or illnesses affecting the brain, such as HIV, Lyme disease or meningitis
- Psychiatric disorders, such as schizophrenia, autism, obsessive compulsive disorder.
- History of 1 year or more of addiction to drugs such as cannabis, alcohol, cocain, heroine, LSD.
- Taking sleeping pills or anti-anxiety medication before the exam
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 |
|---|---|---|
| Immersion in virtual reality using Nordic Neurolab(™) Visual SystemIn addition to the standard MRI procedure, the VR intervention group will be looking at stereoscopic computer generated images through a pair of head-coil-mounted googles (Nordic Neurolab ™ Visual System). Two markers (color balls) will be fixed on their knees to capture their movement (camera tracking from the outside of the MRI room). The VR scenario will consist in showing a replication of the actual MRI examination room, as seen from the point of view of the participant lying on the MRI bed, but without the MRI tunnel. Participant can see themselves in the large room (a simplified gender-matched avatar), and an entertaining video can be displayed. | Device | VR |
Primary outcome
Anxiety level
Time frame: through study completion, an average of one year
Questionnaire on anxiety during scan (9 items)
Interruption
Time frame: through study completion, an average of one year
Record of interruption due to claustrophobia during MRI scan
1 secondary outcome
MRI Image quality
Time frame: through study completion, an average of one year
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 Aug 2024.
- Individual participant dataSharing planned: No
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Evaluation of the Effectiveness of a Cardiac Coherence Exercise on MRI Success and Image Quality in Claustrophobic Patients
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Premedication for Claustrophobic Patients for MRI Scan
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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.
Olaf Blanke principal investigator
Ecole Polytechnique Fédéralede Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersion in virtual reality using Nordic Neurolab(™) Visual System in people with Claustrophobia, run by Ecole Polytechnique Fédérale de Lausanne at 1 site in Switzerland.
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 5 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 Aug 2024. 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 Switzerland. 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 level (time frame: through study completion, an average of one year). The study lists 2 primary outcomes in all. 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 Aug 2024.