Virtual Reality to Alleviate Claustrophobia During MRI

Claustrophobia Clinical Trial

— CLAUSTROVR  

Official title:

Evaluation of the Benefit of Virtual Reality to Alleviate Claustrophobia During MRI Clinical Procedure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04754958
• Other study ID #: VRMRI_LNCO2021
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2021
• Source: Ecole Polytechnique Fédérale de Lausanne
• Contact: Olaf Blanke, Prof
• Phone: 0216939621
• Email: olaf.blanke[@]epfl.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Claustrophobia
• Phobic Disorders

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.

Locations

Country	Name	City	State
Switzerland	Hopitaux Universitaires de Geneve (HUG)	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
Ecole Polytechnique Fédérale de Lausanne	University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety level	Questionnaire on anxiety during scan (9 items)	through study completion, an average of one year
Primary	Interruption	Record of interruption due to claustrophobia during MRI scan	through study completion, an average of one year
Secondary	MRI Image quality	Evaluation of MRI image quality for medical care	through study completion, an average of one year