Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598813
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Pediatric Headche Assessment Using HIT 6
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pediatric Headche Assessment Comparing PedMidas and HIT 6 Questionnaires
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 children39s 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None