Performance of EEG in Children With Medical Clowns (MECLEES)

February 16, 2022 updated by: Jacob.genizi, Bnai Zion Medical Center

Can Medical Clowns Prevent the Usage of Sedation During the Performance of EEG in Young Children

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Haifa, Israel, 3104802
        • Recruiting
        • Bnai Zion Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Medical clown EEG
50 Children performing the EEG at the days that the medical clown is available will be included in the study group.
Behavioral: Medical clown
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.
Other Names:
  • non
No Intervention: Regular EEG
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: 2 years
Child anxiety using the modified Yale Preoperative Anxiety Scale ( mYPAS 5-22 points, higher scores reflects anxity) for assessing child anxiety questionnaire.
2 years
EEG quality
Time Frame: 2 years
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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parent's satisfaction during EEG procedure
Time Frame: 2 Years
Parent's satisfaction from the procedure on 1-5 likert sclae (1-best 5- worst).
2 Years
Technician's satisfaction during EEG procedure
Time Frame: 2 Years
Technician's satisfaction from the procedure on 1-5 likert sclae (1-best 5- worst).
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bnai Zion Medical Center

Investigators

  • Principal Investigator: jacob Genizi, MD, Bnai Zion Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Anticipated)

April 30, 2022

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

January 30, 2022

First Submitted That Met QC Criteria

February 16, 2022

First Posted (Actual)

February 25, 2022

Study Record Updates

Last Update Posted (Actual)

February 25, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • bnz 049-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Child, Only

Clinical Trials on Medical clown

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe