Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2022-12-01
2024-08-01
Brief Summary
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Detailed Description
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Research Objectives: To compare the PED-MIDAS and HIT-6 questionnaires in their ability to assess the degree of impact of headaches on daily functioning.
Research Methods: The study is a prospective cohort study. The study population will include 100 children aged 6-18 years suffering from headaches who visited the Pediatric Neurology Clinic at Bnai Zion Medical Center and completed both the PED-MIDAS and HIT-6 questionnaires, starting from November 2022 until the end of the study period. Data will be collected from medical records and from the two questionnaires completed by the children during their clinic visit.
Research Importance: Children often struggle with completing the PED-MIDAS questionnaire because it requires them to recall the number of days their functioning was impaired over the three months prior to completing the questionnaire. This may lead to inaccurate completion and, consequently, an assessment that does not reflect the true impact. This created the need to compare the PED-MIDAS with the HIT-6 and examine whether it can serve as a better alternative.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Children with haeadche
Children reporting headache for at least 3 month
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Children able to fill the questionnaire
Exclusion Criteria
* Children who are not able to fill the questionnaire
6 Years
18 Years
ALL
No
Sponsors
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Bnai Zion Medical Center
OTHER_GOV
Responsible Party
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Jacob.genizi
Pediatric Neurologist
Locations
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Bnai Zion Medical Cemter
Haif, , Israel
Countries
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References
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Stewart WF, Lipton RB, Kolodner KB, Sawyer J, Lee C, Liberman JN. Validity of the Migraine Disability Assessment (MIDAS) score in comparison to a diary-based measure in a population sample of migraine sufferers. Pain. 2000 Oct;88(1):41-52. doi: 10.1016/S0304-3959(00)00305-5.
Stewart WF, Lipton RB, Dowson AJ, Sawyer J. Development and testing of the Migraine Disability Assessment (MIDAS) Questionnaire to assess headache-related disability. Neurology. 2001;56(6 Suppl 1):S20-8. doi: 10.1212/wnl.56.suppl_1.s20.
Heyer GL, Perkins SQ, Rose SC, Aylward SC, Lee JM. Comparing patient and parent recall of 90-day and 30-day migraine disability using elements of the PedMIDAS and an Internet headache diary. Cephalalgia. 2014 Apr;34(4):298-306. doi: 10.1177/0333102413508240. Epub 2013 Oct 14.
Heyer GL, Merison K, Rose SC, Perkins SQ, Lee JM, Stewart WC. PedMIDAS-based scoring underestimates migraine disability on non-school days. Headache. 2014 Jun;54(6):1048-53. doi: 10.1111/head.12327. Epub 2014 Apr 7.
Livingston RD, Shockey D, Morton L, Rao S. Pediatric Headache Management and Use of the PedMIDAS. J Dr Nurs Pract. 2019 Apr 1;12(1):24-30. doi: 10.1891/2380-9418.12.1.24. Epub 2019 May 9.
Houts CR, Wirth RJ, McGinley JS, Gwaltney C, Kassel E, Snapinn S, Cady R. Content Validity of HIT-6 as a Measure of Headache Impact in People With Migraine: A Narrative Review. Headache. 2020 Jan;60(1):28-39. doi: 10.1111/head.13701. Epub 2019 Dec 6.
Hershey AD, Powers SW, Vockell AL, LeCates S, Kabbouche MA, Maynard MK. PedMIDAS: development of a questionnaire to assess disability of migraines in children. Neurology. 2001 Dec 11;57(11):2034-9. doi: 10.1212/wnl.57.11.2034.
Genizi J, Lahoud D, Cohen R. Migraine abortive treatment in children and adolescents in Israel. Sci Rep. 2022 May 6;12(1):7418. doi: 10.1038/s41598-022-11467-3.
Other Identifiers
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BNZ187-22
Identifier Type: -
Identifier Source: org_study_id
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