Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-29 @ 2:16 AM
Study NCT ID:
NCT07048132
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-15
First Post:
2025-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Turkish Version of the Headache Screening Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D018781', 'term': 'Tension-Type Headache'}, {'id': 'D006261', 'term': 'Headache'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-11', 'studyFirstSubmitDate': '2025-06-21', 'studyFirstSubmitQcDate': '2025-06-28', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICHD-3 Beta Classification', 'timeFrame': 'Day 1, Two weeks later control'}, {'measure': 'Headache Screening Questionare', 'timeFrame': 'Day 1,Two weeks later control'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['migraine', 'tension type headache', 'headache', 'headache screening questionare', 'validation', 'reliability'], 'conditions': ['Migraine', 'Tension Type Headache', 'Headache']}, 'descriptionModule': {'briefSummary': "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.\n\nParticipants 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged 18 and over who present with headache complaints (migraine or tension-type) and voluntarily agree to participate\n\nExclusion Criteria:\n\n* Individuals with severe psychiatric disorders, illiteracy in Turkish, or significant cognitive impairment preventing comprehension of the scale'}, 'identificationModule': {'nctId': 'NCT07048132', 'briefTitle': 'Turkish Version of the Headache Screening Questionnaire', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Başakşehir Çam & Sakura City Hospital'}, 'officialTitle': 'Validity and Reliability of the Turkish Version of the Headache Screening Questionnaire', 'orgStudyIdInfo': {'id': 'B.10.1.TKH.4.34.H.GP.0.01/169'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with headache', 'interventionNames': ['Diagnostic Test: Headache Screening Questionare']}], 'interventions': [{'name': 'Headache Screening Questionare', 'type': 'DIAGNOSTIC_TEST', 'description': '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.\n\nEach item reflects a diagnostic criterion for migraine or TTH. Participants complete the HSQ and are also evaluated by a neurologist for diagnosis.\n\nA score of 6 or higher suggests "probable migraine" or "probable TTH."', 'armGroupLabels': ['Patients with headache']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gizem Gürsoy, Medical Doctor', 'role': 'CONTACT', 'email': 'drgizemgursoy@gmail.com', 'phone': '02166321818'}], 'overallOfficials': [{'name': 'Gizem Gürsoy, Medical Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ümraniye Research and Training Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Başakşehir Çam & Sakura City Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Umraniye Education and Research Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor', 'investigatorFullName': 'Tuba Tanyel Saraçoğlu', 'investigatorAffiliation': 'Başakşehir Çam & Sakura City Hospital'}}}}