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Trial record 2 of 6 for:    "Velopharyngeal Insufficiency"

Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder

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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
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

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).

Condition or disease Intervention/treatment Phase
Velopharyngeal Insufficiency Behavioral: Medical clown Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
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


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. videofluoroscopy data completeness [ Time Frame: 1 year ]
    The quality and completeness of radiological data that can be retrieved from the videofluoroscopy record

  2. length of radiation exposure time [ Time Frame: 1 year ]
    The length of radiation exposure time for the subject, measured in seconds


Secondary Outcome Measures :
  1. Total (gross) time of examination [ Time Frame: 1 year ]
    the total time the patient is in the room, measured in minutes

  2. Subjective level of anxiety [ Time Frame: 1 year ]
    the level of patient's anxiety as defined subjectively in questionnaire

  3. Pulse [ Time Frame: 1 year ]
    The difference in pulse measurement before and after the examination as an indirect assessment of level of anxiety



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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of velo-pharyngeal inadequacy

Exclusion Criteria:

  • a patient or caregiver that did not consent to participate in the study

Information from the National Library of Medicine

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


Contacts
Contact: Yaniv Ebner, MD +972-9-7472553 yaniv.ebner@clalit.org.il
Contact: Noam Banon, MD noam.banon@gmail.com

Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Yaniv Ebner, MD Meir Medical Center

Publications of Results:
Other Publications:
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT02701322     History of Changes
Other Study ID Numbers: 0281-15-MMC
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Meir Medical Center:
Velopharyngeal Insufficiency
Fluoroscopy

Additional relevant MeSH terms:
Velopharyngeal Insufficiency
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mouth Abnormalities
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Diseases
Stomatognathic System Abnormalities
Otorhinolaryngologic Diseases
Congenital Abnormalities