Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder
Primary Purpose
Velopharyngeal Insufficiency
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Medical clown
Sponsored by
About this trial
This is an interventional supportive care trial for Velopharyngeal Insufficiency focused on measuring Velopharyngeal Insufficiency, Fluoroscopy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Medical Clown
Control
Arm Description
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 videofluoroscopic procedure but without a medical clown.
Outcomes
Primary Outcome Measures
videofluoroscopy data completeness
The quality and completeness of radiological data that can be retrieved from the videofluoroscopy record
length of radiation exposure time
The length of radiation exposure time for the subject, measured in seconds
Secondary Outcome Measures
Total (gross) time of examination
the total time the patient is in the room, measured in minutes
Subjective level of anxiety
the level of patient's anxiety as defined subjectively in questionnaire
Pulse
The difference in pulse measurement before and after the examination as an indirect assessment of level of anxiety
Full Information
NCT ID
NCT02701322
First Posted
February 22, 2016
Last Updated
October 11, 2020
Sponsor
Meir Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02701322
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
machine malfunction and updated work rutines
Study Start Date
March 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Velopharyngeal Insufficiency
Keywords
Velopharyngeal Insufficiency, Fluoroscopy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medical Clown
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will do the same videofluoroscopic procedure but without a medical clown.
Intervention Type
Behavioral
Intervention Name(s)
Medical clown
Primary Outcome Measure Information:
Title
videofluoroscopy data completeness
Description
The quality and completeness of radiological data that can be retrieved from the videofluoroscopy record
Time Frame
1 year
Title
length of radiation exposure time
Description
The length of radiation exposure time for the subject, measured in seconds
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Total (gross) time of examination
Description
the total time the patient is in the room, measured in minutes
Time Frame
1 year
Title
Subjective level of anxiety
Description
the level of patient's anxiety as defined subjectively in questionnaire
Time Frame
1 year
Title
Pulse
Description
The difference in pulse measurement before and after the examination as an indirect assessment of level of anxiety
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaniv Ebner, MD
Organizational Affiliation
Meir Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24028842
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.
Results Reference
background
PubMed Identifier
24943088
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.
Results Reference
result
Learn more about this trial
Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder
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