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OpenTrials
Completed

NCT Number: NCT04754958

Virtual Reality to Alleviate Claustrophobia During MRI

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

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopitaux Universitaires de Geneve (HUG)

Geneva, 1205, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Anxiety level

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

    Questionnaire on anxiety during scan (9 items)

  2. Interruption

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

    Record of interruption due to claustrophobia during MRI scan

Secondary outcomes

  1. MRI Image quality

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

    Evaluation of MRI image quality for medical care

Sponsors and collaborators

Lead sponsor

Ecole Polytechnique Fédérale de Lausanne

Other

Collaborators

  • University Hospital, Geneva

Registry information

Official study title

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

Acronym: CLAUSTROVR

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Feb 15, 2021
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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