Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 10
- 主要终点
- videofluoroscopy data completeness
研究概览
简要总结
The purpose of this study is to determine whether a participation of a medical clown in videofluoroscopic examination of pediatric speech disorder such as velopharyngeal inadequacy, improves the collaboration of the pediatric patient, the patient's and the caregivers subjective experience, and the quality of the examination (shorter exposure to radiation, shorter time at the radiology suite, more accurate parameters retrieved from the imaging results).
详细描述
Velopharyngeal inadequacy (VPI) results in reduced speech intelligibility and nasopharyngeal regurgitation. VPI is more common in patients who previously underwent cleft palate repair, in craniofacial syndromes such as 22q11.2 deletion syndrome, or in neuromuscular diseases. Part of the work-up sometimes includes videofluoroscopic examination of the palate's movement during speech. This procedure involves ionizing radiation and requires adequate collaboration by the examinee. The examination set-up is foreign to the child and can cause stres and anxiety which can hinder the examination's accuracy and completion. Medical clowns professionalise in stress relieve.
In this prospective controlled study, the study group will be accompanied by a medical clown from the arrival to the premise, through the actual examination and after exiting the exam room. The medical clown will explain about the upcoming examination and will induce a less stressed atmosphere. After the examination the clown will close the session for the patient.
The control group will do the same procedure but without a medical clown. Factors such as pulse, total time in the examination room, net time of exposure to radiation and quality of data will be collected for each patient. The patient (if 7 year old and up) and his caregivers will fill up after completion of the examination a short questionnaire about their experience.
The data will be collected and summarized and then a statistical analysis will be made in order to compare the study group and 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
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of velo-pharyngeal inadequacy
排除标准
- •a patient or caregiver that did not consent to participate in the study
结局指标
主要结局
videofluoroscopy data completeness
时间窗: 1 year
The quality and completeness of radiological data that can be retrieved from the videofluoroscopy record
length of radiation exposure time
时间窗: 1 year
The length of radiation exposure time for the subject, measured in seconds
次要结局
- Subjective level of anxiety(1 year)
- Pulse(1 year)
- Total (gross) time of examination(1 year)