Evaluation of the Effectiveness of a Cardiac Coherence Exercise on MRI Success and Image Quality in Claustrophobic Patients
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 220
- 主要终点
- Proportion of interpretable MRI exams with good image quality, rated blindly by a radiologist
研究概览
简要总结
Claustrophobia, an intense fear of confined spaces, can significantly impair the success of MRI examinations by causing patient movement or early termination of the scan, leading to poor image quality. Cardiac coherence, a breathing technique aimed at synchronizing heart rate and reducing anxiety, has shown benefits in stress management. This randomized controlled trial aims to evaluate whether the use of a guided cardiac coherence exercise during MRI can improve exam success rates and image quality in self-reported claustrophobic patients compared to standard care (cartoons for children, music for adults). The primary outcome is the proportion of interpretable MRI scans with good-quality images, assessed blindly by a radiologist. Secondary outcomes include exam duration, use of the emergency call button, patient satisfaction, and perceived comfort. A total of 220 patients aged 7 years and older will be enrolled over 12 months at the Fondation Adolphe de Rothschild Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 7 years or older
- •Undergoing a 1.5T or 3T MRI scan as part of routine care
- •Self-reported claustrophobia on the imaging department admission form
- •Explicit consent to participate in the study, provided by the patient or a legal representative (for minors)
- •Affiliated with or beneficiary of a social security system
排除标准
- •Patient under legal protection or guardianship
- •Pregnant or breastfeeding woman
- •Inability to complete questionnaires and/or perform the cardiac coherence exercise as judged by the investigator
结局指标
主要结局
Proportion of interpretable MRI exams with good image quality, rated blindly by a radiologist
时间窗: Day 1
This outcome measures the proportion of MRI exams considered interpretable and of good quality, based on image assessment by a radiologist blinded to the intervention group. Any exam for which all planned sequences could not be acquired is considered a failure. Each image is scored on a 5-point scale: No artifacts; Minor artifacts (edges only), not interfering with interpretation; Moderate artifacts, not interfering with interpretation; Significant artifacts, partial interpretation possible; Major artifacts, hindering interpretation. An exam is considered of good quality if all images are rated as 1 or 2.
次要结局
未报告次要终点