An interventional study of Medical clown in Velopharyngeal Insufficiency, sponsored by Meir Medical Center. Terminated. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-10-14.
Sponsored by Meir Medical Center · Not applicable, Interventional, and Supportive care
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).
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.
Exclusion Criteria:
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
The control group will do the same videofluoroscopic procedure but without a medical clown.
videofluoroscopy data completeness
The quality and completeness of radiological data that can be retrieved from the videofluoroscopy record
Time frame: 1 year
length of radiation exposure time
The length of radiation exposure time for the subject, measured in seconds
Time frame: 1 year
Total (gross) time of examination
the total time the patient is in the room, measured in minutes
Time frame: 1 year
Subjective level of anxiety
the level of patient's anxiety as defined subjectively in questionnaire
Time frame: 1 year
Pulse
The difference in pulse measurement before and after the examination as an indirect assessment of level of anxiety
Time frame: 1 year
No study locations are listed for this record.
Plan to share: Undecided
This study is terminated, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Meir Medical Center