Clinical trial NCT06598813: Pediatric Headche Assessment Using HIT 6
Official title: Pediatric Headche Assessment Comparing PedMidas and HIT 6 Questionnaires
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache Disorders, Primary
Keywords: HEADACHE
MIGRAINE
assessment
PEDMIDAS
HIT 6
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with headache

Brief summary: 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.

Detailed description: Abstarct Background: Headache is one of the most common complaints in children and adolescents and is a leading cause of functional impairment in teenagers and young adults. The most common primary headaches being migraine and tension-type headache. Headaches negatively impact children\&#39;s lives in various ways, with the effect varying according to the severity of the pain, the duration of the attack, and the response to treatment. To assess the degree of impact of headaches on daily functioning, the PED-MIDAS questionnaire was developed, tested, and validated in children aged 4-18 years, however, children often face difficulties in completing the questionnaire. The HIT-6 questionnaire, on the other hand, is user friendly however is validated only for adults.

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.

Eligibility criteria: Inclusion Criteria:

* Chldern age 6-18 years with headache for at least 3 months.
* Children able to fill the questionnaire

Exclusion Criteria:

* Children with shoreter headaches.
* Children who are not able to fill the questionnaire

Primary outcomes:
measure: Hit 6 questionnaire
timeFrame: Once
Secondary outcomes:
Other outcomes:
Locations:
city: Haif
country: Israel
facility: Bnai Zion Medical Cemter
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.