Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder

Sponsor
Meir Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT02701322
Collaborator
(none)
10
2
13

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Medical clown
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
10 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
Actual Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Feb 1, 2017
Actual Study Completion Date :
Apr 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. videofluoroscopy data completeness [1 year]

    The quality and completeness of radiological data that can be retrieved from the videofluoroscopy record

  2. length of radiation exposure time [1 year]

    The length of radiation exposure time for the subject, measured in seconds

Secondary Outcome Measures

  1. Total (gross) time of examination [1 year]

    the total time the patient is in the room, measured in minutes

  2. Subjective level of anxiety [1 year]

    the level of patient's anxiety as defined subjectively in questionnaire

  3. Pulse [1 year]

    The difference in pulse measurement before and after the examination as an indirect assessment of level of anxiety

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Clinical diagnosis of velo-pharyngeal inadequacy
Exclusion Criteria:
  • a patient or caregiver that did not consent to participate in the study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Meir Medical Center

Investigators

  • Principal Investigator: Yaniv Ebner, MD, Meir Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT02701322
Other Study ID Numbers:
  • 0281-15-MMC
First Posted:
Mar 8, 2016
Last Update Posted:
Oct 14, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Meir Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2020