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Virtual Reality to Alleviate Claustrophobia During MRI (CLAUSTROVR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04754958
Recruitment Status : Not yet recruiting
First Posted : February 15, 2021
Last Update Posted : March 22, 2021
Sponsor:
Collaborator:
University Hospital, Geneva
Information provided by (Responsible Party):
Olaf Blanke, Ecole Polytechnique Fédérale de Lausanne

Brief Summary:
This study evaluates if our Virtual Reality (VR) simulation inside the MRI efficiently alleviates symptoms of claustrophobia for patients during the MRI examination.

Condition or disease Intervention/treatment Phase
Claustrophobia Device: Immersion in virtual reality using Nordic Neurolab(™) Visual System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Invervention group / no intervention group (standard of care)
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Benefit of Virtual Reality to Alleviate Claustrophobia During MRI Clinical Procedure
Estimated Study Start Date : March 25, 2021
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: VR
In addition to standard care during MRI scan, patient receives VR intervention.
Device: Immersion in virtual reality using Nordic Neurolab(™) Visual System
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.

No Intervention: No VR
Standard of care during MRI scan.



Primary Outcome Measures :
  1. Anxiety level [ Time Frame: through study completion, an average of one year ]
    Questionnaire on anxiety during scan (9 items)

  2. Interruption [ Time Frame: through study completion, an average of one year ]
    Record of interruption due to claustrophobia during MRI scan


Secondary Outcome Measures :
  1. MRI Image quality [ Time Frame: through study completion, an average of one year ]
    Evaluation of MRI image quality for medical care



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04754958


Contacts
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Contact: Olaf Blanke, Prof 0216939621 ext +41 olaf.blanke@epfl.ch
Contact: Bruno Herbelin, Dr 21 693 04 67 ext +41 bruno.herbelin@epfl.ch

Locations
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Switzerland
Hopitaux Universitaires de Geneve (HUG)
Geneva, Switzerland, 1205
Contact: Maria Isabel Vargas, Prof       Maria.I.Vargas@hcuge.ch   
Contact: Karl-Olof Lovblad, Prof       Karl-Olof.Lovblad@hcuge.ch   
Sponsors and Collaborators
Ecole Polytechnique Fédérale de Lausanne
University Hospital, Geneva
Investigators
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Principal Investigator: Olaf Blanke Ecole Polytechnique Fédéralede Lausanne
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Responsible Party: Olaf Blanke, Professor Doctor, Ecole Polytechnique Fédérale de Lausanne
ClinicalTrials.gov Identifier: NCT04754958    
Other Study ID Numbers: VRMRI_LNCO2021
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Phobic Disorders
Anxiety Disorders
Mental Disorders