Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder

Velopharyngeal Insufficiency Clinical Trial

Official title:

Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02701322
• Other study ID #: 0281-15-MMC
• Status: Terminated
• Phase: N/A
• Start date: March 2016
• Est. completion date: April 2017

Study information

• Verified date: October 2020
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of velo-pharyngeal inadequacy

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Speech Disorders
• Velopharyngeal Insufficiency

Intervention

Behavioral:
• Medical clown

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	videofluoroscopy data completeness	The quality and completeness of radiological data that can be retrieved from the videofluoroscopy record	1 year
Primary	length of radiation exposure time	The length of radiation exposure time for the subject, measured in seconds	1 year
Secondary	Total (gross) time of examination	the total time the patient is in the room, measured in minutes	1 year
Secondary	Subjective level of anxiety	the level of patient's anxiety as defined subjectively in questionnaire	1 year
Secondary	Pulse	The difference in pulse measurement before and after the examination as an indirect assessment of level of anxiety	1 year