Virtual Reality to Alleviate Claustrophobia During MRI

NCT04754958 | Completed DMC

• 1 other identifier: VRMRI_LNCO2021
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Claustrophobia

Outcome Measures

Primary Outcomes (2)

• Anxiety level

  Questionnaire on anxiety during scan (9 items)

  through study completion, an average of one year

• Interruption

  Record of interruption due to claustrophobia during MRI scan

  through study completion, an average of one year

Secondary Outcomes (1)

• MRI Image quality

  through study completion, an average of one year

Study Arms (2)

VR

EXPERIMENTAL

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

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

No VR

NO INTERVENTION

Standard of care during MRI scan.

Interventions

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

VR

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ecole Polytechnique Fédérale de Lausanne: lead
• University Hospital, Geneva: collaborator

Study Sites (1)

Hopitaux Universitaires de Geneve (HUG)

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

Claustrophobia

Interventions

Immersion

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Olaf Blanke

  Ecole Polytechnique Fédéralede Lausanne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Model Details: Invervention group / no intervention group (standard of care)

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 15, 2021
• Study Start: July 20, 2021
• Primary Completion: December 1, 2023
• Study Completion: February 28, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)