IMPACT OF CHILDREN&Apos;S PREPARATION BEFORE MRI ON ANXIETY AND NEED FOR ANESTHESIA: A PROSPECTIVE RANDOMIZED CLINICAL TRIAL.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Proportion of children which will be anesthetized
研究概览
简要总结
MRI has been recognized for many years as the safest and the most precise imaging method, particularly for children. However, the accuracy of MRI demands from the patient to avoid any movement while the examination is in process. This task is accomplished with difficulty by children and requires the assistance of an anesthetizing staff. In this research, our main goal is to investigate an introductory instruction as an assistive tool in performing MRI without the need in anesthesia.
详细描述
This is a prospective randomized controlled trial in which the level of the child's exposure to instruction is controlled according to the group he is attributed to. The children are divided randomly, each Sunday (the day there is an available anesthesia staff) we change the extent of the instruction. We use two types of instructions: 1) Full interactive instruction- which will include an instructional booklet, a movie and a simulator's practice. 2) Partial instruction which will include the booklet only.
Therefore, if it is a full instruction Sunday, all the children in that day receive full instruction and vice versa, if it will is a partial instruction Sunday, all the children in that day receive partial instruction.
All participants provide written informed consent after the study aims and procedures are fully explained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All children in the age between 5 to 16 years who come ambulatory or were hospitalized to perform an MRI test, speaks Hebrew or Arabic, are capable of understanding to their age, and their parents agreed to take part in the research
排除标准
- •Severe cerebral palsy
- •Severe ADHD
- •Children that lack of communication skills
结局指标
主要结局
Proportion of children which will be anesthetized
时间窗: 2 years
次要结局
未报告次要终点
研究者
Ilan Shelef
Department of Radiology
Soroka University Medical Center