Clinical Trial: Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder
Brief Summary: 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).
Detailed Summary:
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.
Sponsor: Meir Medical Center
Current Primary Outcome:
- videofluoroscopy data completeness [ Time Frame: 1 year ]The quality and completeness of radiological data that can be retrieved from the videofluoroscopy record
- length of radiation exposure time [ Time Frame: 1 year ]The length of radiation exposure time for the subject, measured in seconds
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Total (gross) time of examination [ Time Frame: 1 year ]the total time the patient is in the room, measured in minutes
- Subjective level of anxiety [ Time Frame: 1 year ]the level of patient's anxiety as defined subjectively in questionnaire
- Pulse [ Time Frame: 1 year ]The difference in pulse measurement before and after the examination as an indirect assessment of level of anxiety
Original Secondary Outcome: Same as current
Information By: Meir Medical Center
Dates:
Date Received: February 22, 2016
Date Started: March 2016
Date Completion: April 2017
Last Updated: March 7, 2016
Last Verified: February 2016
