MigraineNCT07048132
Turkish Version of the Headache Screening Questionnaire
An observational study of Migraine and Tension Type Headache, run by Başakşehir Çam & Sakura City Hospital.
Trial summary
This multi-center, nationwide study aims to evaluate the validity and reliability of the Turkish version of the Headache Screening Questionnaire (HSQ-TR). The 10-item questionnaire is designed to screen for migraine and tension-type headache in individuals with headache complaints. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Tension Type Headache, Headache
- What is being tested?
- Headache Screening Questionare
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2025to 15 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years old) presenting with headache complaints (migraine or tension-type headache) at outpatient neurology clinics in participating hospitals. Participants must be literate in Turkish and cognitively capable of completing self-report questionnaires. A total of 100 patients will be enrolled across multiple centers in Turkey.
Who may be able to join
- Individuals aged 18 and over who present with headache complaints (migraine or tension-type) and voluntarily agree to participate
Who cannot join
- Individuals with severe psychiatric disorders, illiteracy in Turkish, or significant cognitive impairment preventing comprehension of the scale
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Validity and Reliability of the Turkish Version of the Headache Screening Questionnaire
This multi-center, nationwide study aims to evaluate the validity and reliability of the Turkish version of the Headache Screening Questionnaire (HSQ-TR). The 10-item questionnaire is designed to screen for migraine and tension-type headache in individuals with headache complaints.
Participants presenting with headache will be enrolled. Each participant will first complete the HSQ-TR and then be examined by a neurologist who will provide a diagnosis according to the ICHD-3 beta criteria. The questionnaire results will be compared with the neurologist's diagnoses to assess criterion validity, including sensitivity, specificity, and agreement.
- Conditions
- Migraine, Tension Type Headache, Headache
- Being tested
- Headache Screening Questionare
- Keywords
- migraine, tension type headache, headache, headache screening questionare, validation, reliability
- Medical subject headings
- Migraine Disorders, Tension-Type Headache, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Headache Screening QuestionareDiagnostic test
The Headache Screening Questionnaire (HSQ) is a 10-item tool developed to screen for migraine and tension-type headache (TTH), based on the ICHD-3 beta criteria.
Each item reflects a diagnostic criterion for migraine or TTH. Participants complete the HSQ and are also evaluated by a neurologist for diagnosis.
A score of 6 or higher suggests "probable migraine" or "probable TTH."
| Study group | Role | What they receive |
|---|---|---|
| Patients with headache | Not described Receives: Diagnostic Test: Headache Screening Questionare |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICHD-3 Beta Classification
Measured: Day 1, Two weeks later control
Headache Screening Questionare
Measured: Day 1,Two weeks later control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Collaborators
- Umraniye Education and Research Hospital
- Responsible party
- Principal investigator, Tuba Tanyel Saraçoğlu, Başakşehir Çam & Sakura City Hospital
- Investigators
- Gizem Gürsoy, Medical Doctor, Principal investigator, Ümraniye Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048132
- Sponsor's protocol ID
- B.10.1.TKH.4.34.H.GP.0.01/169
- Status last verified
- Jun 2025
- First submitted
- 21 Jun 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Turkish Version of the Headache Screening Questionnaire
- ClinicalTrials.gov ID
- NCT07048132
- Acronym / sponsor ID
- B.10.1.TKH.4.34.H.GP.0.01/169
- Conditions
- Migraine, Tension Type Headache, Headache
- Keywords
- migraine, tension type headache, headache, headache screening questionare, validation, reliability
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Collaborators
- Umraniye Education and Research Hospital
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 2 Jul 2025 (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.
This multi-center, nationwide study aims to evaluate the validity and reliability of the Turkish version of the Headache Screening Questionnaire (HSQ-TR). The 10-item questionnaire is designed to screen for migraine and tension-type headache in individuals with headache complaints.
Participants presenting with headache will be enrolled. Each participant will first complete the HSQ-TR and then be examined by a neurologist who will provide a diagnosis according to the ICHD-3 beta criteria. The questionnaire results will be compared with the neurologist's diagnoses to assess criterion validity, including sensitivity, specificity, and agreement.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with headache | – | Diagnostic Test: Headache Screening Questionare |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years old) presenting with headache complaints (migraine or tension-type headache) at outpatient neurology clinics in participating hospitals. Participants must be literate in Turkish and cognitively capable of completing self-report questionnaires. A total of 100 patients will be enrolled across multiple centers in Turkey.
Key inclusion criteria (1 listed)
- Individuals aged 18 and over who present with headache complaints (migraine or tension-type) and voluntarily agree to participate
Key exclusion criteria (1 listed)
- Individuals with severe psychiatric disorders, illiteracy in Turkish, or significant cognitive impairment preventing comprehension of the scale
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Headache Screening QuestionareThe Headache Screening Questionnaire (HSQ) is a 10-item tool developed to screen for migraine and tension-type headache (TTH), based on the ICHD-3 beta criteria. Each item reflects a diagnostic criterion for migraine or TTH. Participants complete the HSQ and are also evaluated by a neurologist for diagnosis. A score of 6 or higher suggests "probable migraine" or "probable TTH." | Diagnostic test | Patients with headache |
Primary outcome
ICHD-3 Beta Classification
Time frame: Day 1, Two weeks later control
Headache Screening Questionare
Time frame: Day 1,Two weeks later control
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Gizem Gürsoy, Medical Doctor principal investigator
Ümraniye Research and Training Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Tension Type Headache, run by Başakşehir Çam & Sakura City Hospital.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gizem Gürsoy, Medical Doctor (02166321818, drgizemgursoy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICHD-3 Beta Classification (time frame: Day 1, Two weeks later control). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2025.