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Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder
1 other identifier
interventional
10
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedOctober 14, 2020
October 1, 2020
11 months
February 22, 2016
October 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Total (gross) time of examination
1 year
Subjective level of anxiety
1 year
Pulse
1 year
Study Arms (2)
Medical Clown
EXPERIMENTALthe 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.
Control
NO INTERVENTIONThe control group will do the same videofluoroscopic procedure but without a medical clown.
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of velo-pharyngeal inadequacy
You may not qualify if:
- a patient or caregiver that did not consent to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 24028842BACKGROUNDGoldberg 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.
PMID: 24943088RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yaniv Ebner, MD
Meir Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2016
First Posted
March 8, 2016
Study Start
March 1, 2016
Primary Completion
February 1, 2017
Study Completion
April 1, 2017
Last Updated
October 14, 2020
Record last verified: 2020-10