Virtual Reality to Alleviate Claustrophobia During MRI (CLAUSTROVR)

March 18, 2021 updated by: Olaf Blanke, Ecole Polytechnique Fédérale de Lausanne

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR
In addition to standard care during MRI scan, patient receives VR 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.
No Intervention: No VR
Standard of care during MRI scan.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI Image quality
Time Frame: through study completion, an average of one year
Evaluation of MRI image quality for medical care
through study completion, an average of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ecole Polytechnique Fédérale de Lausanne

Collaborators

University Hospital, Geneva

Investigators

  • Principal Investigator: Olaf Blanke, Ecole Polytechnique Fédéralede Lausanne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 25, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2021

Last Update Submitted That Met QC Criteria

March 18, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VRMRI_LNCO2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Claustrophobia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe