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Clinical Trials/NCT04754958
NCT04754958CompletedNot Applicable

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

Ecole Polytechnique Fédérale de Lausanne2 sites in 1 country24 target enrollmentStarted: July 20, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
2
Primary Endpoint
Anxiety level

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Anxiety level

Time Frame: through study completion, an average of one year

Questionnaire on anxiety during scan (9 items)

Interruption

Time Frame: through study completion, an average of one year

Record of interruption due to claustrophobia during MRI scan

Secondary Outcomes

  • MRI Image quality(through study completion, an average of one year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Olaf Blanke

Professor Doctor

Ecole Polytechnique Fédérale de Lausanne

Study Sites (2)

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