EvaLuation De L'apport De L'Irm Virtuelle Sur La Qualité De La Prise En Charge Des Enfants En Irm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
The access to MRI examination is limited due to the duration of the acquisitions, the noise and the narrow patient space of the device. A child can, therefore, be anxious, less cooperative and move more during the acquisition, affecting the quality of the examination and the medical diagnosis. General anesthesia or sedation, may be considered to obtain diagnostic quality examinations. Our hypothesis is that a scenario as close as possible to reality to prepare children before the MR exam could reduce their anxiety, improve the quality of the exams and reduce its duration.
The purpose of this study is to evaluate the effect of virtual reality on MRI exam preparation to reduce the anxiety of children (aged from 6 to 12 years) who are referred to their first MRI exam, as compared to the current practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child from 6 to 12 years old,
- •Child who will have an MRI for the first time,
- •Outpatient child,
- •Child dependent on a parent affiliated to or beneficiary of a social security scheme,
- •Child who has received age-appropriate information on the organization of the research,
- •Child whose parents (or the only parent present with parental authority) have been fully informed about the organization of the research and have signed informed consent.
排除标准
- •Conditions that not allow the realization of a virtual MRI sceanrio or not allow to respond the scales (epilepsy, mental disorders, language, ...),
- •Child with a contraindication to performing an MRI,
- •Child who has benefited from another MRI simulation system before ("IRM en Jeu" for instance)
- •Child's opposition to participate.
结局指标
主要结局
Anxiety
时间窗: 2 hours
Anxiety measurement before and after MRI by Visual Analogue Scale between 0 and 10
次要结局
未报告次要终点
研究者
Servait Coralie
Radiology technician
Central Hospital, Nancy, France