Use of an Infotainment System in MRI in Patients Suffering From Unexpected Anxiety.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of brain MRI sequences reported as interpretable
研究概览
简要总结
MRI scans are now considered essential for diagnosing or monitoring disease, and as a result, the number of MRI scans has increased significantly in recent years.
Nevertheless, these routine examinations remain a source of apprehension and anxiety for some people.
The objective of this study is to compare two methods of care, enabling anxious individuals to complete their MRI examination and obtain images of sufficient quality for the radiologist to read and interpret.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who have given their verbal consent
- •Individuals over the age of 18
- •Hospitalized or ambulatory individuals who are able-bodied and scheduled to undergo a brain MRI scan on the 1.5T A MRI machine at the Dijon University Hospital.
- •Individuals reporting anxiety about brain MRI for the first time upon admission by the radiology technician.
排除标准
- •Persons not affiliated with or not covered by a social security system
- •Persons subject to legal protection measures (guardianship, trusteeship)
- •Persons subject to judicial protection measures
- •Women who know they are pregnant
- •Adults who are incapable or unable to give their consent
- •Persons with contraindications to MRI
- •Persons who have already undergone an MRI accompanied by hypnosis
- •Persons who do not speak French
- •Persons who cannot read French
- •Persons with cognitive disorders
- •Persons who have taken sedatives before the examination
- •Persons who regularly take anxiolytic medication and have increased their usual dose before the examination
- •Persons who have already participated in the study
研究组 & 干预措施
Experimental Innovision©
干预措施: Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire (Other)
Experimental Innovision©
干预措施: Anxiety support procedure according to randomization: Innovision© or Hypnosis (Other)
Hypnosis control
干预措施: Assessment of patient anxiety through self-administration of the State Anxiety Inventory Form Y-A questionnaire (Other)
Hypnosis control
干预措施: Anxiety support procedure according to randomization: Innovision© or Hypnosis (Other)
结局指标
主要结局
Percentage of brain MRI sequences reported as interpretable
时间窗: Baseline
Percentage of brain MRI sequences reported as interpretable
时间窗: Baseline
次要结局
未报告次要终点