Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-28 @ 8:11 PM
Study NCT ID:
NCT04754958
Status:
COMPLETED
Last Update Posted:
2024-08-28
First Post:
2021-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality to Alleviate Claustrophobia During MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098452', 'term': 'Claustrophobia'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007101', 'term': 'Immersion'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Invervention group / no intervention group (standard of care)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-26', 'studyFirstSubmitDate': '2021-02-09', 'studyFirstSubmitQcDate': '2021-02-11', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety level', 'timeFrame': 'through study completion, an average of one year', 'description': 'Questionnaire on anxiety during scan (9 items)'}, {'measure': 'Interruption', 'timeFrame': 'through study completion, an average of one year', 'description': 'Record of interruption due to claustrophobia during MRI scan'}], 'secondaryOutcomes': [{'measure': 'MRI Image quality', 'timeFrame': 'through study completion, an average of one year', 'description': 'Evaluation of MRI image quality for medical care'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Claustrophobia']}, 'descriptionModule': {'briefSummary': 'This study evaluates if our Virtual Reality (VR) simulation inside the MRI efficiently alleviates symptoms of claustrophobia for patients during the MRI examination.', 'detailedDescription': '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).\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indicating suffering from claustrophobia\n* Be aged between 18 and 40 year-old\n* Being able to give consent\n* Being able to understand and speak French or English\n* Being MRI-compatible\n\nExclusion Criteria:\n\n* Epilepsy or illnesses affecting the brain, such as HIV, Lyme disease or meningitis\n* Psychiatric disorders, such as schizophrenia, autism, obsessive compulsive disorder.\n* History of 1 year or more of addiction to drugs such as cannabis, alcohol, cocain, heroine, LSD.\n* Taking sleeping pills or anti-anxiety medication before the exam'}, 'identificationModule': {'nctId': 'NCT04754958', 'acronym': 'CLAUSTROVR', 'briefTitle': 'Virtual Reality to Alleviate Claustrophobia During MRI', 'organization': {'class': 'OTHER', 'fullName': 'Ecole Polytechnique Fédérale de Lausanne'}, 'officialTitle': 'Evaluation of the Benefit of Virtual Reality to Alleviate Claustrophobia During MRI Clinical Procedure', 'orgStudyIdInfo': {'id': 'VRMRI_LNCO2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VR', 'description': 'In addition to standard care during MRI scan, patient receives VR intervention.', 'interventionNames': ['Device: Immersion in virtual reality using Nordic Neurolab(™) Visual System']}, {'type': 'NO_INTERVENTION', 'label': 'No VR', 'description': 'Standard of care during MRI scan.'}], 'interventions': [{'name': 'Immersion in virtual reality using Nordic Neurolab(™) Visual System', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['VR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hopitaux Universitaires de Geneve (HUG)', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Olaf Blanke', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ecole Polytechnique Fédéralede Lausanne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ecole Polytechnique Fédérale de Lausanne', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Geneva', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Doctor', 'investigatorFullName': 'Olaf Blanke', 'investigatorAffiliation': 'Ecole Polytechnique Fédérale de Lausanne'}}}}