Virtual Reality to Alleviate Claustrophobia During MRI

NCT ID: NCT04754958

Last Updated: 2024-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-20
• Study Completion Date: 2024-02-28

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

VR

In addition to standard care during MRI scan, patient receives VR intervention.

Group Type: EXPERIMENTAL

Immersion in virtual reality using Nordic Neurolab(™) Visual System

Intervention Type: DEVICE

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 VR

Standard of care during MRI scan.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: collaborator

Ecole Polytechnique Fédérale de Lausanne

OTHER

Sponsor Role: lead

Responsible Party

Olaf Blanke

Professor Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olaf Blanke

Role: PRINCIPAL_INVESTIGATOR

Ecole Polytechnique Fédéralede Lausanne

Locations

Hopitaux Universitaires de Geneve (HUG)

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

VRMRI_LNCO2021

Identifier Type: -

Identifier Source: org_study_id