Can Medical Clowns Prevent the Usage of Sedation During the Performance of EEG in Young Children
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
EEG is an important test in the diagnosis epilepsy. The test does not hart, however many electrodes are attached to the child's scalp and situation is stressful. In order to achieve cooperation some use sedative drugs such as Chloralhydrate in young children. The investigetors believe that the integration of medical clowns in the EEG test can distract the children from the stressful environment and encourage them to cooperate. This can prevent the need of using sedation, can improve the quality of the test and improve the child's and parent's experience. One hundred children ages 1-10 years of age performing EEG test at the Bnai Zion medical center will be randomly divided into two groups. One group will the perform the test in the regular practice, and in the other half, medical clowns will be part of the test. The process will be rated by the child, his parents, the EEG technician and the physician reading the EEG. The two groups will be compared in all assessed measures through a statistical analysis.
详细描述
Can Medical Clowns prevent the usage of sedation during the performance of EEG in Young Children MECLEES - MEdical CLowns EEg Study
The study will be performed at the Pediatric Neurology Unit in Bnai Zion Medical Center, Haifa, Israel.
Purpose The aim our study is to investigate the performance of EEG in young children in cooperation with medical clowns. Can the presence of a medical clown prevent the need of using sedation? Does it improve the child's and parent's experience? Does it improve the quality of the test?
Study procedure The children will be divided to either group randomly according to the day of the test.
- 50 Children performing the EEG at the days that the medical clown is available will be included in the study group.
- 50 Children performing the EEG at the days that the medical clown is unavailable will be included in the control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
The EEG reading will be blinded to the intervention arm
入排标准
- 年龄范围
- 1 Month 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Anxiety
时间窗: 2 years
Child anxiety using the modified Yale Preoperative Anxiety Scale ( mYPAS 5-22 points, higher scores reflects anxity) for assessing child anxiety questionnaire.
EEG quality
时间窗: 2 years
Electroencephalogram (EEG) quality will be evaluated by both technicians and the physicians independently in 1-5 likert sclae (1-best 5- worst). The physician will be blinded to the presence of a medical clown during the test.
次要结局
- Technician's satisfaction during EEG procedure(2 Years)
- Parent's satisfaction during EEG procedure(2 Years)
研究者
Jacob.genizi
Director Pediatric Departement
Bnai Zion Medical Center