Clinical trial NCT04754958: Virtual Reality to Alleviate Claustrophobia During MRI
Official title: Evaluation of the Benefit of Virtual Reality to Alleviate Claustrophobia During MRI Clinical Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Claustrophobia
Lead sponsor: Ecole Polytechnique Fédérale de Lausanne
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
First posted: 2021-02-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Invervention group / no intervention group (standard of care)
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Anxiety level
timeFrame: through study completion, an average of one year
measure: Interruption
timeFrame: through study completion, an average of one year
Secondary outcomes:
measure: MRI Image quality
timeFrame: through study completion, an average of one year
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hopitaux Universitaires de Geneve (HUG)
Study officials:
affiliation: Ecole Polytechnique Fédéralede Lausanne
name: Olaf Blanke
role: PRINCIPAL_INVESTIGATOR
References: