Virtual Reality to Alleviate Claustrophobia During MRI

Not Applicable

Completed

• Conditions: Claustrophobia
• Interventions: Device: Immersion in virtual reality using Nordic Neurolab(™) Visual System

• Registration Number: NCT04754958
• Lead Sponsor: Ecole Polytechnique Fédérale de Lausanne

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.

Study Timeline

• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-11
• Study First Posted: 2021-02-15
• Study Start: 2021-07-20
• Primary Completion: 2023-12-01
• Study Completion: 2024-02-28
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR	Immersion in virtual reality using Nordic Neurolab(™) Visual System	In addition to standard care during MRI scan, patient receives VR intervention.

Primary Outcome Measures

Name	Time	Method
Anxiety level	through study completion, an average of one year	Questionnaire on anxiety during scan (9 items)
Interruption	through study completion, an average of one year	Record of interruption due to claustrophobia during MRI scan

Secondary Outcome Measures

Name	Time	Method
MRI Image quality	through study completion, an average of one year	Evaluation of MRI image quality for medical care

Trial Locations

Locations (1)

Hopitaux Universitaires de Geneve (HUG); 🇨🇭 Geneva, Switzerland