NCT06598813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.7 years

First QC Date

September 12, 2024

Last Update Submit

September 17, 2024

Conditions

Headache Disorders, Primary

Keywords

HEADACHEMIGRAINEassessmentPEDMIDASHIT 6

Outcome Measures

Primary Outcomes (1)

  • Hit 6 questionnaire

    The hit 6 headache levels compered to the Pedmidas levels

    Once

Study Arms (1)

Children with haeadche

Children reporting headache for at least 3 month

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children with headache

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Medical Cemter

Haif, 3104802, Israel

Location

Related Publications (8)

  • 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.

    PMID: 11098098BACKGROUND

  • 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.

    PMID: 11294956BACKGROUND

  • 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.

    PMID: 24126944BACKGROUND

  • 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.

    PMID: 24708311BACKGROUND

  • 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.

    PMID: 32745052BACKGROUND

  • 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.

    PMID: 31811654BACKGROUND

  • 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.

    PMID: 11739822BACKGROUND

  • 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.

    PMID: 35523834BACKGROUND

MeSH Terms

Conditions

Headache Disorders, PrimaryHeadacheMigraine Disorders

Condition Hierarchy (Ancestors)

Headache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Neurologist

Study Record Dates

First Submitted

September 12, 2024

First Posted

September 19, 2024

Study Start

December 1, 2022

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

IL(1)