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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
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Velopharyngeal Insufficiency focused on measuring Velopharyngeal Insufficiency, Fluoroscopy

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 22, 2016
    Last Updated
    October 11, 2020
    Sponsor
    Meir Medical Center
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    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

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    Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder

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