Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder

Conditions
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Velopharyngeal Insufficiency

Intervention / Treatment
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* Behavioral: Medical clown


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of velo-pharyngeal inadequacy Exclusion Criteria: a patient or caregiver that did not consent to participate in the study

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Medical Clown<br>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. | Behavioral: Medical clown<br> <br> |
| No Intervention: Control<br>The control group will do the same videofluoroscopic procedure but without a medical clown. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| videofluoroscopy data completeness | The quality and completeness of radiological data that can be retrieved from the videofluoroscopy record | 1 year | 
| length of radiation exposure time | The length of radiation exposure time for the subject, measured in seconds | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total (gross) time of examination | the total time the patient is in the room, measured in minutes | 1 year | 
| Subjective level of anxiety | the level of patient's anxiety as defined subjectively in questionnaire | 1 year | 
| Pulse | The difference in pulse measurement before and after the examination as an indirect assessment of level of anxiety | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Velopharyngeal Insufficiency, Fluoroscopy