| Registry | NCT02701322 |
|---|---|
| Status | Terminated - machine malfunction and updated work rutines |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 10 (Actual) |
| Sponsor | Meir Medical Center (Other) |
| Conditions | Velopharyngeal Insufficiency |
| Interventions | Medical clown (Behavioral) |
| Dates | start 2016-03-01, primary completion 2017-02-01, completion 2017-04-01, first posted 2016-03-08, last updated 2020-10-14 |
Related Papers Related Patents Related Grants Related Experts
All trials for Velopharyngeal Insufficiency All trials of Medical clown
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).
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Medical Clown | Experimental | Behavioral: 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. |
| Control | No intervention | The control group will do the same videofluoroscopic procedure but without a medical clown. |
Sex: All, ages: 3 Years to 18 Years
Inclusion Criteria: * Clinical diagnosis of velo-pharyngeal inadequacy Exclusion Criteria: * a patient or caregiver that did not consent to participate in the study