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Virtual Reality to Alleviate Claustrophobia During MRI (CLAUSTROVR)

Primary Purpose

Claustrophobia

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Immersion in virtual reality using Nordic Neurolab(™) Visual System
Sponsored by
Ecole Polytechnique Fédérale de Lausanne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Claustrophobia

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hopitaux Universitaires de Geneve (HUG)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

VR

No VR

Arm Description

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

Standard of care during MRI scan.

Outcomes

Primary Outcome Measures

Anxiety level
Questionnaire on anxiety during scan (9 items)
Interruption
Record of interruption due to claustrophobia during MRI scan

Secondary Outcome Measures

MRI Image quality
Evaluation of MRI image quality for medical care

Full Information

First Posted
February 9, 2021
Last Updated
March 18, 2021
Sponsor
Ecole Polytechnique Fédérale de Lausanne
Collaborators
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT04754958
Brief Title
Virtual Reality to Alleviate Claustrophobia During MRI
Acronym
CLAUSTROVR
Official Title
Evaluation of the Benefit of Virtual Reality to Alleviate Claustrophobia During MRI Clinical Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 25, 2021 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ecole Polytechnique Fédérale de Lausanne
Collaborators
University Hospital, Geneva

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Claustrophobia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Invervention group / no intervention group (standard of care)
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VR
Arm Type
Experimental
Arm Description
In addition to standard care during MRI scan, patient receives VR intervention.
Arm Title
No VR
Arm Type
No Intervention
Arm Description
Standard of care during MRI scan.
Intervention Type
Device
Intervention Name(s)
Immersion in virtual reality using Nordic Neurolab(™) Visual System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Anxiety level
Description
Questionnaire on anxiety during scan (9 items)
Time Frame
through study completion, an average of one year
Title
Interruption
Description
Record of interruption due to claustrophobia during MRI scan
Time Frame
through study completion, an average of one year
Secondary Outcome Measure Information:
Title
MRI Image quality
Description
Evaluation of MRI image quality for medical care
Time Frame
through study completion, an average of one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olaf Blanke, Prof
Phone
0216939621
Ext
+41
Email
olaf.blanke@epfl.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Herbelin, Dr
Phone
21 693 04 67
Ext
+41
Email
bruno.herbelin@epfl.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olaf Blanke
Organizational Affiliation
Ecole Polytechnique Fédéralede Lausanne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopitaux Universitaires de Geneve (HUG)
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Isabel Vargas, Prof
Email
Maria.I.Vargas@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Karl-Olof Lovblad, Prof
Email
Karl-Olof.Lovblad@hcuge.ch

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual Reality to Alleviate Claustrophobia During MRI

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