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临床试验/NCT04754958
NCT04754958已完成不适用

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

Ecole Polytechnique Fédérale de Lausanne2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年7月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
2
主要终点
Anxiety level

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Anxiety level

时间窗: through study completion, an average of one year

Questionnaire on anxiety during scan (9 items)

Interruption

时间窗: through study completion, an average of one year

Record of interruption due to claustrophobia during MRI scan

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olaf Blanke

Professor Doctor

Ecole Polytechnique Fédérale de Lausanne

研究点 (2)

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