Headache Disorders, PrimaryNCT06598813
Pediatric Headche Assessment Using HIT 6
An observational study of Headache Disorders, Primary, run by Bnai Zion Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Headache Disorders, Primary
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2022to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: children with headache
Who may be able to join
- Chldern age 6-18 years with headache for at least 3 months.
- Children able to fill the questionnaire
Who cannot join
- Children with shoreter headaches.
- Children who are not able to fill the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pediatric Headche Assessment Comparing PedMidas and HIT 6 Questionnaires
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.
Read the 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.
- Conditions
- Headache Disorders, Primary
- Keywords
- HEADACHE, MIGRAINE, assessment, PEDMIDAS, HIT 6
- Medical subject headings
- Headache Disorders, Primary, Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with haeadche | Children reporting headache for at least 3 month |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hit 6 questionnaire
The hit 6 headache levels compered to the Pedmidas levels
Measured: Once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Dec 2022
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Headache Disorders, PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jacob.genizi, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598813
- Sponsor's protocol ID
- BNZ187-22
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 11098098Stewart 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.
PubMed 11294956Heyer 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.
PubMed 24126944Heyer 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.
PubMed 24708311Livingston 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.
PubMed 32745052Houts 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.
PubMed 31811654Hershey 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.
PubMed 11739822Genizi 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.
PubMed 35523834
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Headche Assessment Comparing PedMidas and HIT 6 Questionnaires
- ClinicalTrials.gov ID
- NCT06598813
- Acronym / sponsor ID
- BNZ187-22
- Conditions
- Headache Disorders, Primary
- Keywords
- HEADACHE, MIGRAINE, assessment, PEDMIDAS, HIT 6
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with haeadche | – | –Children reporting headache for at least 3 month |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- children with headache
Key inclusion criteria (2 listed)
- Chldern age 6-18 years with headache for at least 3 months.
- Children able to fill the questionnaire
Key exclusion criteria (2 listed)
- Children with shoreter headaches.
- Children who are not able to fill the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hit 6 questionnaire
Time frame: Once
The hit 6 headache levels compered to the Pedmidas levels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 11098098Stewart 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.
- Results publication: PubMed 11294956Stewart 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.
- Results publication: PubMed 24126944Heyer 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.
- Results publication: PubMed 24708311Heyer 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.
- Results publication: PubMed 32745052Livingston 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.
- Results publication: PubMed 31811654Houts 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.
- Results publication: PubMed 11739822Hershey 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.
- Results publication: PubMed 35523834Genizi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache Disorders, Primary, run by Bnai Zion Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hit 6 questionnaire (time frame: Once). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06598813, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.