Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02701322|
Recruitment Status : Unknown
Verified February 2016 by Meir Medical Center.
Recruitment status was: Not yet recruiting
First Posted : March 8, 2016
Last Update Posted : March 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Velopharyngeal Insufficiency||Behavioral: Medical clown||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||February 2017|
|Estimated Study Completion Date :||April 2017|
Experimental: Medical Clown
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
No Intervention: Control
The control group will do the same videofluoroscopic procedure but without a medical clown.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701322
|Contact: Yaniv Ebner, MDfirstname.lastname@example.org|
|Contact: Noam Banon, MDemail@example.com|
|Principal Investigator:||Yaniv Ebner, MD||Meir Medical Center|