Evaluating the Contribution of Hypnosis on Image Quality During Cardiac Magnetic Resonance Imaging (MRI) in Anxious Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- quality of cardiac MRI images
研究概览
简要总结
The present project aims to explore the effect of a hypnosis session performed on a patient with anxiety during a cardiac MRI examination on image quality.
详细描述
Cardiac Magnetic Resonance Imaging (MRI) is an activity of the Bordeaux University Hospital that continues to grow (+7.3% in 2021 compared to 2019) under the combined effect of the increase in activity of cardiology care channels and the extension of clinical indications for cardiac MRI. Indeed, cardiac MRI has become an essential examination in the diagnosis of many heart diseases and is little practiced elsewhere in New Aquitaine. The current delay for a cardiac MRI is 3 and a half months.
In this context, it is necessary to be efficient because any procedure failure, examination interruption or insufficient image quality can delay the diagnosis and therapeutic management of the patient for several months. Numerous studies have shown that anxiety induces interruptions in the acquisition of MRI images and repetition of sequences, thus prolonging the examination time.
However, no study takes into account the specificity of cardiac MRI, whose image quality is intimately linked to the patient's cooperation and to the synchronization of the sequences with the heart rhythm.
Hypnosis seems to be adapted to reduce the patient's anxiety, by allowing him to ignore the surrounding reality while remaining in relation with the attendant.
The hypothesis is that by reducing patient anxiety through hypnosis, image quality in cardiac MRI would be improved.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Anxious patient (anxiety score TRAIT (baseline) and anxiety score STATE (situational) ≥ 46) and non-anxious patient (anxiety score TRAIT and anxiety score STATE < 46) requiring cardiac MRI for diagnosis or follow-up of a cardiac pathology except the patients with cardiac arrhythmias or irregular heartbeats.
- •18 years and older
- •Highly effective contraception for women of childbearing potential, maintained during research procedures
- •Informed consent
- •Affiliated or beneficiary of health insurance
排除标准
- •Contraindications to MRI and gadoline contrast medium
- •Hearing impaired patients
- •Patients who do not speak French
- •Women who are pregnant or lactating
- •Inability to agree to participate to the study
- •Patient under legal protection
结局指标
主要结局
quality of cardiac MRI images
时间窗: Baseline
Likert score measurements
次要结局
- Anxiety level(Baseline)
- Causality score measurement(Baseline)
- Number of repeated or interrupted sequences(Baseline)
- Overall duration(Baseline)
- number of artifacts(Baseline)
- Diagnostic validation score(Baseline)
- Post-MRI satisfaction score(Baseline)