Velopharyngeal InsufficiencyNCT02701322
Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder
A study testing Medical clown in people with Velopharyngeal Insufficiency, run by Meir Medical Center.
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… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Velopharyngeal Insufficiency
- What is being tested?
- Medical clown
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of velo-pharyngeal inadequacy
Who cannot join
- a patient or caregiver that did not consent to participate in the study
About this study
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).
Read the 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.
- Conditions
- Velopharyngeal Insufficiency
- Being tested
- Medical clown
- Keywords
- Velopharyngeal Insufficiency, Fluoroscopy
- Medical subject headings
- Velopharyngeal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical clownBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Medical Clown | Experimental | 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. Receives: Behavioral: Medical clown |
| Control | No intervention | The control group will do the same videofluoroscopic procedure but without a medical clown. |
What is being measured
The primary outcome is the main question the study is designed to answer.
videofluoroscopy data completeness
The quality and completeness of radiological data that can be retrieved from the videofluoroscopy record
Measured: 1 year
length of radiation exposure time
The length of radiation exposure time for the subject, measured in seconds
Measured: 1 year
Secondary outcomes (3)
Total (gross) time of examination
the total time the patient is in the room, measured in minutes
Measured: 1 year
Subjective level of anxiety
the level of patient's anxiety as defined subjectively in questionnaire
Measured: 1 year
Pulse
The difference in pulse measurement before and after the examination as an indirect assessment of level of anxiety
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionFeb 2017
- Study completionApr 2017
Why it stopped: machine malfunction and updated work rutines
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Velopharyngeal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yaniv Ebner, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701322
- Sponsor's protocol ID
- 0281-15-MMC
- Status last verified
- Oct 2020
- First submitted
- 22 Feb 2016
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24028842Goldberg 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.
PubMed 24943088
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Medical Clowning in Videofluoroscopic Examination of Pediatric Speech Disorder
- ClinicalTrials.gov ID
- NCT02701322
- Acronym / sponsor ID
- 0281-15-MMC
- Conditions
- Velopharyngeal Insufficiency
- Keywords
- Velopharyngeal Insufficiency, Fluoroscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: machine malfunction and updated work rutines
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical Clown | Experimental | Behavioral: Medical clownthe 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of velo-pharyngeal inadequacy
Key exclusion criteria (1 listed)
- a patient or caregiver that did not consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical clown | Behavioural | Medical Clown |
Primary outcome
videofluoroscopy data completeness
Time frame: 1 year
The quality and completeness of radiological data that can be retrieved from the videofluoroscopy record
length of radiation exposure time
Time frame: 1 year
The length of radiation exposure time for the subject, measured in seconds
3 secondary outcomes
Total (gross) time of examination
Time frame: 1 year
Subjective level of anxiety
Time frame: 1 year
Pulse
Time frame: 1 year
Results and safety
The study was stopped early (reason given: machine malfunction and updated work rutines). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Background: PubMed 24028842Wolyniez 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 publication: PubMed 24943088Goldberg 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaniv Ebner, MD principal investigator
Meir Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Medical clown in people with Velopharyngeal Insufficiency, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: machine malfunction and updated work rutines). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
videofluoroscopy data completeness (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02701322, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.