EEG With Periodic AbnormalitiesMECLEESNCT05257096
Performance of EEG in Children With Medical Clowns
A study testing Medical clown in people with EEG With Periodic Abnormalities and Child, Only, run by Bnai Zion Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 10 years
- Conditions the study is for
- EEG With Periodic Abnormalities, Child, Only
- 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
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 May 2019to 30 Apr 2022
- 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 1 month to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children age 1-10 years
- Undergoing EEG test at the Bnai Zion Medical Center.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Bnai Zion Medical Center
Haifa, 3104802
Jacob Genizi, MD, 972-4-8359662, genizij@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- EEG With Periodic Abnormalities, Child, Only
- Being tested
- Medical clown
- Keywords
- EEG with Periodic Abnormalities, Play Role, Child, Only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical clownBehavioural
Also called non
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Child anxiety using the modified Yale Preoperative Anxiety Scale ( mYPAS 5-22 points, higher scores reflects anxity) for assessing child anxiety questionnaire.
Measured: 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.
Measured: 2 years
Secondary outcomes (2)
Parent's satisfaction during EEG procedure
Parent's satisfaction from the procedure on 1-5 likert sclae (1-best 5- worst).
Measured: 2 Years
Technician's satisfaction during EEG procedure
Technician's satisfaction from the procedure on 1-5 likert sclae (1-best 5- worst).
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start1 May 2019
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for EEG With Periodic AbnormalitiesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jacob.genizi, Bnai Zion Medical Center
- Investigators
- Jacob genizi, md, Principal investigator, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05257096
- Sponsor's protocol ID
- bnz 049-19
- Acronym
- MECLEES
- Status last verified
- Feb 2022
- First submitted
- 30 Jan 2022
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bornstein Y. [Medical clowns at hospitals and their effect on hospitalized children]. Harefuah. 2008 Jan;147(1):30-2, 95, 94. Hebrew.
PubMed 18300620Britton JW, Kosa SC. The clinical value of chloral hydrate in the routine electroencephalogram. Epilepsy Res. 2010 Feb;88(2-3):215-20. doi: 10.1016/j.eplepsyres.2009.11.012. Epub 2009 Dec 23.
PubMed 20031374Olson DM, Sheehan MG, Thompson W, Hall PT, Hahn J. Sedation of children for electroencephalograms. Pediatrics. 2001 Jul;108(1):163-5. doi: 10.1542/peds.108.1.163.
PubMed 11433070Sanborn PA, Michna E, Zurakowski D, Burrows PE, Fontaine PJ, Connor L, Mason KP. Adverse cardiovascular and respiratory events during sedation of pediatric patients for imaging examinations. Radiology. 2005 Oct;237(1):288-94. doi: 10.1148/radiol.2371041415.
PubMed 16183936Malviya S, Voepel-Lewis T, Prochaska G, Tait AR. Prolonged recovery and delayed side effects of sedation for diagnostic imaging studies in children. Pediatrics. 2000 Mar;105(3):E42. doi: 10.1542/peds.105.3.e42.
PubMed 10699144Cote CJ, Notterman DA, Karl HW, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: a critical incident analysis of contributing factors. Pediatrics. 2000 Apr;105(4 Pt 1):805-14. doi: 10.1542/peds.105.4.805.
PubMed 10742324Vagnoli L, Caprilli S, Robiglio A, Messeri A. Clown doctors as a treatment for preoperative anxiety in children: a randomized, prospective study. Pediatrics. 2005 Oct;116(4):e563-7. doi: 10.1542/peds.2005-0466.
PubMed 16199685Golan G, Tighe P, Dobija N, Perel A, Keidan I. Clowns for the prevention of preoperative anxiety in children: a randomized controlled trial. Paediatr Anaesth. 2009 Mar;19(3):262-6. doi: 10.1111/j.1460-9592.2008.02903.x. Epub 2008 Dec 23.
PubMed 19143948Dvory A, Goshen Y, Ruimi S, Bikov S, Halevy R, Koren A. Dream Doctor Intervention Instead of Sedation: Performing Radionuclide Scanning Without Sedation in Young Children: A Study in 142 Patients. J Altern Complement Med. 2016 May;22(5):408-12. doi: 10.1089/acm.2015.0090. Epub 2016 Mar 30.
PubMed 27028874Wassmer E, Carter PF, Quinn E, McLean N, Welsh G, Seri S, Whitehouse WP. Melatonin is useful for recording sleep EEGs: a prospective audit of outcome. Dev Med Child Neurol. 2001 Nov;43(11):735-8. doi: 10.1017/s0012162201001347.
PubMed 11730146Loewy J, Hallan C, Friedman E, Martinez C. Sleep/sedation in children undergoing EEG testing: a comparison of chloral hydrate and music therapy. Am J Electroneurodiagnostic Technol. 2006 Dec;46(4):343-55.
PubMed 17285817Slifer KJ, Avis KT, Frutchey RA. Behavioral intervention to increase compliance with electroencephalographic procedures in children with developmental disabilities. Epilepsy Behav. 2008 Jul;13(1):189-95. doi: 10.1016/j.yebeh.2008.01.013. Epub 2008 Mar 17.
PubMed 18348911Fong CY, Lim WK, Li L, Lai NM. Chloral hydrate as a sedating agent for neurodiagnostic procedures in children. Cochrane Database Syst Rev. 2021 Aug 16;8(8):CD011786. doi: 10.1002/14651858.CD011786.pub3.
PubMed 34397100Goldberg 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 24943088Meiri N, Ankri A, Hamad-Saied M, Konopnicki M, Pillar G. The effect of medical clowning on reducing pain, crying, and anxiety in children aged 2-10 years old undergoing venous blood drawing--a randomized controlled study. Eur J Pediatr. 2016 Mar;175(3):373-9. doi: 10.1007/s00431-015-2652-z. Epub 2015 Oct 16.
PubMed 26475347
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Medical Clowns Prevent the Usage of Sedation During the Performance of EEG in Young Children
- ClinicalTrials.gov ID
- NCT05257096
- Acronym / sponsor ID
- MECLEES / bnz 049-19
- Conditions
- EEG With Periodic Abnormalities, Child, Only
- Keywords
- EEG with Periodic Abnormalities, Play Role, Child, Only
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 25 Feb 2022 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Medical clown EEG | Experimental | Behavioral: Medical clown50 Children performing the EEG at the days that the medical clown is available will be included in the study group. |
| 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. |
Who may qualify
- Ages
- 1 month to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children age 1-10 years
- Undergoing EEG test at the Bnai Zion Medical Center.
Key exclusion criteria (3 listed)
- 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.
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 clownAlso: nonThe 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. | Behavioural | Medical clown EEG |
Primary outcome
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.
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 secondary outcomes
Parent's satisfaction during EEG procedure
Time frame: 2 Years
Technician's satisfaction during EEG procedure
Time frame: 2 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Results publication: PubMed 18300620Bornstein Y. [Medical clowns at hospitals and their effect on hospitalized children]. Harefuah. 2008 Jan;147(1):30-2, 95, 94. Hebrew.
- Results publication: PubMed 20031374Britton JW, Kosa SC. The clinical value of chloral hydrate in the routine electroencephalogram. Epilepsy Res. 2010 Feb;88(2-3):215-20. doi: 10.1016/j.eplepsyres.2009.11.012. Epub 2009 Dec 23.
- Results publication: PubMed 11433070Olson DM, Sheehan MG, Thompson W, Hall PT, Hahn J. Sedation of children for electroencephalograms. Pediatrics. 2001 Jul;108(1):163-5. doi: 10.1542/peds.108.1.163.
- Results publication: PubMed 16183936Sanborn PA, Michna E, Zurakowski D, Burrows PE, Fontaine PJ, Connor L, Mason KP. Adverse cardiovascular and respiratory events during sedation of pediatric patients for imaging examinations. Radiology. 2005 Oct;237(1):288-94. doi: 10.1148/radiol.2371041415.
- Results publication: PubMed 10699144Malviya S, Voepel-Lewis T, Prochaska G, Tait AR. Prolonged recovery and delayed side effects of sedation for diagnostic imaging studies in children. Pediatrics. 2000 Mar;105(3):E42. doi: 10.1542/peds.105.3.e42.
- Results publication: PubMed 10742324Cote CJ, Notterman DA, Karl HW, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: a critical incident analysis of contributing factors. Pediatrics. 2000 Apr;105(4 Pt 1):805-14. doi: 10.1542/peds.105.4.805.
- Results publication: PubMed 16199685Vagnoli L, Caprilli S, Robiglio A, Messeri A. Clown doctors as a treatment for preoperative anxiety in children: a randomized, prospective study. Pediatrics. 2005 Oct;116(4):e563-7. doi: 10.1542/peds.2005-0466.
- Results publication: PubMed 19143948Golan G, Tighe P, Dobija N, Perel A, Keidan I. Clowns for the prevention of preoperative anxiety in children: a randomized controlled trial. Paediatr Anaesth. 2009 Mar;19(3):262-6. doi: 10.1111/j.1460-9592.2008.02903.x. Epub 2008 Dec 23.
- Results publication: PubMed 27028874Dvory A, Goshen Y, Ruimi S, Bikov S, Halevy R, Koren A. Dream Doctor Intervention Instead of Sedation: Performing Radionuclide Scanning Without Sedation in Young Children: A Study in 142 Patients. J Altern Complement Med. 2016 May;22(5):408-12. doi: 10.1089/acm.2015.0090. Epub 2016 Mar 30.
- Results publication: PubMed 11730146Wassmer E, Carter PF, Quinn E, McLean N, Welsh G, Seri S, Whitehouse WP. Melatonin is useful for recording sleep EEGs: a prospective audit of outcome. Dev Med Child Neurol. 2001 Nov;43(11):735-8. doi: 10.1017/s0012162201001347.
- Results publication: PubMed 17285817Loewy J, Hallan C, Friedman E, Martinez C. Sleep/sedation in children undergoing EEG testing: a comparison of chloral hydrate and music therapy. Am J Electroneurodiagnostic Technol. 2006 Dec;46(4):343-55.
- Results publication: PubMed 18348911Slifer KJ, Avis KT, Frutchey RA. Behavioral intervention to increase compliance with electroencephalographic procedures in children with developmental disabilities. Epilepsy Behav. 2008 Jul;13(1):189-95. doi: 10.1016/j.yebeh.2008.01.013. Epub 2008 Mar 17.
- Individual participant dataSharing planned: No
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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.
Jacob genizi, md principal investigator
Bnai Zion Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical clown in people with EEG With Periodic Abnormalities and Child, Only, run by Bnai Zion Medical Center at 1 site in Israel.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jacob Genizi (972-48359662, genizij@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 2 years). 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 NCT05257096, which also lists 24 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 25 Feb 2022.