Performance of EEG in Children With Medical Clowns (MECLEES)
Primary Purpose
EEG With Periodic Abnormalities, Child, Only
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Medical clown
Sponsored by
About this trial
This is an interventional prevention trial for EEG With Periodic Abnormalities focused on measuring EEG with Periodic Abnormalities, Play Role, Child, Only
Eligibility Criteria
Inclusion Criteria
- Children age 1-10 years
- Undergoing EEG test at the Bnai Zion Medical Center.
Exclusion Criteria
- Children younger than 1 year or older than 10 years
- Children using sedation for the test.
- A child or a family that refuses to participate initially or during the test.
Sites / Locations
- Bnai Zion Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Medical clown EEG
Regular EEG
Arm Description
50 Children performing the EEG at the days that the medical clown is available will be included in the study group.
50 Children performing the EEG at the days that the medical clown is unavailable will be included in the control group. The EEG will be performed in the traditional way without medical clowns.
Outcomes
Primary Outcome Measures
Anxiety
Child anxiety using the modified Yale Preoperative Anxiety Scale ( mYPAS 5-22 points, higher scores reflects anxity) for assessing child anxiety questionnaire.
EEG quality
Electroencephalogram (EEG) quality will be evaluated by both technicians and the physicians independently in 1-5 likert sclae (1-best 5- worst). The physician will be blinded to the presence of a medical clown during the test.
Secondary Outcome Measures
Parent's satisfaction during EEG procedure
Parent's satisfaction from the procedure on 1-5 likert sclae (1-best 5- worst).
Technician's satisfaction during EEG procedure
Technician's satisfaction from the procedure on 1-5 likert sclae (1-best 5- worst).
Full Information
NCT ID
NCT05257096
First Posted
January 30, 2022
Last Updated
February 16, 2022
Sponsor
Bnai Zion Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05257096
Brief Title
Performance of EEG in Children With Medical Clowns
Acronym
MECLEES
Official Title
Can Medical Clowns Prevent the Usage of Sedation During the Performance of EEG in Young Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bnai Zion Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
EEG is an important test in the diagnosis epilepsy. The test does not hart, however many electrodes are attached to the child's scalp and situation is stressful. In order to achieve cooperation some use sedative drugs such as Chloralhydrate in young children. The investigetors believe that the integration of medical clowns in the EEG test can distract the children from the stressful environment and encourage them to cooperate. This can prevent the need of using sedation, can improve the quality of the test and improve the child's and parent's experience. One hundred children ages 1-10 years of age performing EEG test at the Bnai Zion medical center will be randomly divided into two groups. One group will the perform the test in the regular practice, and in the other half, medical clowns will be part of the test. The process will be rated by the child, his parents, the EEG technician and the physician reading the EEG. The two groups will be compared in all assessed measures through a statistical analysis.
Detailed Description
Can Medical Clowns prevent the usage of sedation during the performance of EEG in Young Children MECLEES - MEdical CLowns EEg Study
The study will be performed at the Pediatric Neurology Unit in Bnai Zion Medical Center, Haifa, Israel.
Purpose The aim our study is to investigate the performance of EEG in young children in cooperation with medical clowns. Can the presence of a medical clown prevent the need of using sedation? Does it improve the child's and parent's experience? Does it improve the quality of the test?
Study procedure The children will be divided to either group randomly according to the day of the test.
50 Children performing the EEG at the days that the medical clown is available will be included in the study group.
50 Children performing the EEG at the days that the medical clown is unavailable will be included in the control group.
Study group: The medical clown will meet the children in the waiting room for 15-30 minutes and will accompany them through the whole investigation, up to one hour.
Control group: children that will perform EEG without a medical clown, will perform it either with sedation or without one according to the common practice.
Outcome measures
The following parameters will be assessed (Appendix 1-4):
Child anxiety using mYPAS (10-11) for assessing child anxiety questionnaire.
Parent's satisfaction.
Technician's evaluation.
EEG quality will be evaluated by both technicians and the physicians independently. The physician will be blinded to the presence of a medical clown during the test.
Ethical consideration:
Prior to study ignition IRB approval will be obtained. Any change in the study protocol must be re-approved by the IRB.
All patients enrolled to the study must provide their written consent prior to entering the study. The informed consent will be signed by the parents and retained by the investigator as a part of the study records.
No records of names or identification will be published.
Statistical analysis The study will be randomized and controlled. The physician assessing the EEG will be blinded, however the child, his parents and the EEG technician's will not be blinded. Study and control groups will be compared via independent t-tests, significance will be considered if p<0.05.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
EEG With Periodic Abnormalities, Child, Only
Keywords
EEG with Periodic Abnormalities, Play Role, Child, Only
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The children will be divided to either group randomly according to the day of the test.
50 Children performing the EEG at the days that the medical clown is available will be included in the study group.
50 Children performing the EEG at the days that the medical clown is unavailable will be included in the control group.
Masking
Investigator
Masking Description
The EEG reading will be blinded to the intervention arm
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Medical clown EEG
Arm Type
Experimental
Arm Description
50 Children performing the EEG at the days that the medical clown is available will be included in the study group.
Arm Title
Regular EEG
Arm Type
No Intervention
Arm Description
50 Children performing the EEG at the days that the medical clown is unavailable will be included in the control group. The EEG will be performed in the traditional way without medical clowns.
Intervention Type
Behavioral
Intervention Name(s)
Medical clown
Other Intervention Name(s)
non
Intervention Description
The medical clown will meet the children in the waiting room for 15-30 minutes and will accompany them through the whole investigation, up to one hour.
Primary Outcome Measure Information:
Title
Anxiety
Description
Child anxiety using the modified Yale Preoperative Anxiety Scale ( mYPAS 5-22 points, higher scores reflects anxity) for assessing child anxiety questionnaire.
Time Frame
2 years
Title
EEG quality
Description
Electroencephalogram (EEG) quality will be evaluated by both technicians and the physicians independently in 1-5 likert sclae (1-best 5- worst). The physician will be blinded to the presence of a medical clown during the test.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Parent's satisfaction during EEG procedure
Description
Parent's satisfaction from the procedure on 1-5 likert sclae (1-best 5- worst).
Time Frame
2 Years
Title
Technician's satisfaction during EEG procedure
Description
Technician's satisfaction from the procedure on 1-5 likert sclae (1-best 5- worst).
Time Frame
2 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Children age 1-10 years
Undergoing EEG test at the Bnai Zion Medical Center.
Exclusion Criteria
Children younger than 1 year or older than 10 years
Children using sedation for the test.
A child or a family that refuses to participate initially or during the test.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jacob Genizi
Phone
972-48359662
Email
genizij@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob genizi, md
Organizational Affiliation
Bnai Zion Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
3104802
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Genizi, MD
Phone
972-4-8359662
Email
genizij@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Performance of EEG in Children With Medical Clowns
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