Evaluation of the Benefit of Virtual Reality to Alleviate Claustrophobia During MRI Clinical Procedure
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
- 是
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
Olaf Blanke
Professor Doctor
Ecole Polytechnique Fédérale de Lausanne
