Virtual Reality to Alleviate Claustrophobia During MRI (CLAUSTROVR)
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|ClinicalTrials.gov Identifier: NCT04754958|
Recruitment Status : Not yet recruiting
First Posted : February 15, 2021
Last Update Posted : March 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Claustrophobia||Device: Immersion in virtual reality using Nordic Neurolab(™) Visual System||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|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|
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.
- 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
- MRI Image quality [ Time Frame: through study completion, an average of one year ]Evaluation of MRI image quality for medical care
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
|Contact: Olaf Blanke, Prof||0216939621 ext +firstname.lastname@example.org|
|Contact: Bruno Herbelin, Dr||21 693 04 67 ext +email@example.com|
|Principal Investigator:||Olaf Blanke||Ecole Polytechnique Fédéralede Lausanne|