Performance of EEG in Children With Medical Clowns

NCT05257096 | Unknown

• 1 other identifier: bnz 049-19
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

EEG With Periodic Abnormalities; Child, Only

Keywords

EEG with Periodic Abnormalities; Play Role; Child, Only

Outcome Measures

Primary Outcomes (2)

• Anxiety

  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

  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 Outcomes (2)

• Parent's satisfaction during EEG procedure

  2 Years

• Technician's satisfaction during EEG procedure

  2 Years

Study Arms (2)

Medical clown EEG

EXPERIMENTAL

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

Behavioral: Medical clown

Regular EEG

NO INTERVENTION

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.

Interventions

Medical clown BEHAVIORAL

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.

Also known as: non

Medical clown EEG

Eligibility Criteria

• Age: 1 Month - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children age 1-10 years
• Undergoing EEG test at the Bnai Zion Medical Center.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

Study Sites (1)

Bnai Zion Medical Center

Haifa, 3104802, Israel

RECRUITING

Related Publications (24)

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  PMID: 18300620 RESULT

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  PMID: 20031374 RESULT

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  PMID: 19143948 RESULT

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  PMID: 18348911 RESULT

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  PMID: 34397100 RESULT

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  PMID: 35838778 DERIVED

Study Officials

• Jacob genizi, md

  Bnai Zion Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jacob Genizi

CONTACT

972-48359662; genizij@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The EEG reading will be blinded to the intervention arm
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Pediatric Departement

Model Details: 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 Record Dates

• First Submitted: January 30, 2022
• First Posted: February 25, 2022
• Study Start: May 1, 2019
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)