Clinical trial NCT05257096: Performance of EEG in Children With Medical Clowns
Official title: Can Medical Clowns Prevent the Usage of Sedation During the Performance of EEG in Young Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: EEG With Periodic Abnormalities
Child, Only
Keywords: EEG with Periodic Abnormalities
Play Role
Child, Only
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2022-02-25
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The children will be divided to either group randomly according to the day of the test.

1. 50 Children performing the EEG at the days that the medical clown is available will be included in the study group.
2. 50 Children performing the EEG at the days that the medical clown is unavailable will be included in the control group.
Primary purpose: PREVENTION

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.

1. 50 Children performing the EEG at the days that the medical clown is available will be included in the study group.
2. 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):

1. Child anxiety using mYPAS (10-11) for assessing child anxiety questionnaire.
2. Parent's satisfaction.
3. Technician's evaluation.
4. 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.

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.

Primary outcomes:
measure: Anxiety
timeFrame: 2 years
measure: EEG quality
timeFrame: 2 years
Secondary outcomes:
measure: Parent's satisfaction during EEG procedure
timeFrame: 2 Years
measure: Technician's satisfaction during EEG procedure
timeFrame: 2 Years
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
affiliation: Bnai Zion Medical Center
name: Jacob genizi, md
role: PRINCIPAL_INVESTIGATOR
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