An observational study in Headache Disorders, Primary, sponsored by Bnai Zion Medical Center. Completed at 1 site in Israel. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Bnai Zion Medical Center · Observational
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.
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\'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.
42 studies on the registry are indexed under Headache Disorders, Primary; 13 are open to participants now.
This study's enrollment of 100 is below the median of 120 across 21 observational studies indexed under Headache Disorders, Primary.
Browse Headache Disorders, Primary studies →Bnai Zion Medical Center is the lead sponsor of 104 studies on the registry; 13 are open to participants now.
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children with headache
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Exclusion Criteria:
Children reporting headache for at least 3 month
Hit 6 questionnaire
The hit 6 headache levels compered to the Pedmidas levels
Time frame: Once
Plan to share: Undecided
Ran from Dec 2022 to primary completion in Aug 2024, 20 months.
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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