Clinical trial NCT02701322: Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder
Official title: Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Velopharyngeal Insufficiency
Keywords: Velopharyngeal Insufficiency
Fluoroscopy
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 description: 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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of velo-pharyngeal inadequacy

Exclusion Criteria:

* a patient or caregiver that did not consent to participate in the study

Primary outcomes:
measure: videofluoroscopy data completeness
timeFrame: 1 year
measure: length of radiation exposure time
timeFrame: 1 year
Secondary outcomes:
measure: Total (gross) time of examination
timeFrame: 1 year
measure: Subjective level of anxiety
timeFrame: 1 year
measure: Pulse
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Meir Medical Center
name: Yaniv Ebner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolyniez I, Rimon A, Scolnik D, Gruber A, Tavor O, Haviv E, Glatstein M. The effect of a medical clown on pain during intravenous access in the pediatric emergency department: a randomized prospective pilot study. Clin Pediatr (Phila). 2013 Dec;52(12):1168-72. doi: 10.1177/0009922813502257. Epub 2013 Sep 11.
citation: Goldberg A, Stauber T, Peleg O, Hanuka P, Eshayek L, Confino-Cohen R. Medical clowns ease anxiety and pain perceived by children undergoing allergy prick skin tests. Allergy. 2014 Oct;69(10):1372-9. doi: 10.1111/all.12463. Epub 2014 Aug 4.