Pediatric Headche Assessment Using HIT 6 | NCT06598813

Studies
Pediatric Headche Assessment Using HIT 6

NCT06598813

Sponsor

Bnai Zion Medical Center

Status

Completed

Last Update Posted

Sep 19, 2024Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Headache Disorders, Primary

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2022Actual

Primary Completion Date

Aug 1, 2024Actual

Completion Date

Aug 1, 2024Actual

First Submitted Date

Sep 12, 2024

First Submission Date that Met QC Criteria

Sep 17, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2024

Last Update Posted Date

Sep 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jacob.genizi, Pediatric Neurologist, Bnai Zion Medical CenterPrincipal Investigator

Lead Sponsor

Bnai Zion Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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'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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Children with haeadche		Children reporting headache for at least 3 month

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hit 6 questionnaire	The hit 6 headache levels compered to the Pedmidas levels	Once

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

children with headache

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bnai Zion Medical Cemter		Haif		3104802	Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11098098	Result	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.
11294956	Result	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.

ID	Term
D051270	Headache Disorders, Primary
D006261	Headache
D008881	Migraine Disorders

ID	Term
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases