Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-01-01 @ 2:50 AM
Study NCT ID:
NCT07124234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-15
First Post:
2025-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Social Anxiety on Adolescents Diagnosed With Primary Headache: A Case-control Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072861', 'term': 'Phobia, Social'}], 'ancestors': [{'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-08', 'studyFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total score on the Social Anxiety Scale for Adolescents (SAS-A)', 'timeFrame': 'Day 1', 'description': 'The SAS-A, a self-administered 22-item Likert-scale questionnaire'}], 'secondaryOutcomes': [{'measure': 'Prevalence of clinically significant social anxiety (SAS-A = 50)', 'timeFrame': 'Day 1', 'description': 'Classification based on SAS-A total score cut-off'}, {'measure': 'Body Mass Index (BMI) differences between groups', 'timeFrame': 'Day 1', 'description': 'BMI calculated as kg/m²'}, {'measure': 'Parental smoking status', 'timeFrame': 'Day 1', 'description': 'Self-report from caregiver; statistical comparison of SAS-A scores by smoking exposure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Headache', 'Social Anxiety Disorder']}, 'descriptionModule': {'briefSummary': 'This case-control study will examine whether adolescents aged 12-18 years with a diagnosis of primary headache are more likely to experience elevated social anxiety compared to matched healthy controls. Social anxiety will be assessed using the SAS-A, and the study will also explore whether environmental and sociodemographic factors such as tobacco smoke exposure, BMI, and parental education influence this relationship.', 'detailedDescription': "The study will include adolescents aged 12-18 years who have been diagnosed with primary headachebased on the International Classification of Headache Disorders, 3rd edition (ICHD-3). The main exposure ofinterest will be the presence and severity of social anxiety, which will be measured using the Social AnxietyScale for Adolescents (SAS-A), a validated self-report questionnaire. The SAS-A takes approximately 10minutes to complete. Additional variables that will be collected will include sociodemographiccharacteristics, BMI, parental education levels, income status, parental smoking habits, and theadolescent's exposure to secondhand and thirdhand tobacco smoke. All assessments, includingquestionnaires and physical measurements (height and weight), are expected to be completed inapproximately 20 minutes per participant. The total observation duration for each participant will be about30 minutes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Case group: Participants who will be diagnosed with primary headache according to InternationalClassification of Headache Disorders, 3rd edition (ICHD-3) criteria, confirmed by a pediatric neurologist Control group: Participants who will have no history of recurrent headache or chronic physical/psychiatricillness', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescents aged 12-18 years\n* Case group: Participants who will be diagnosed with primary headache according to InternationalClassification of Headache Disorders, 3rd edition (ICHD-3) criteria, confirmed by a pediatric neurologist\n* Control group: Participants who will have no history of recurrent headache or chronic physical/psychiatricillness\n\nExclusion Criteria:\n\n* History of neurological disease other than primary headache\n* Any previously diagnosed psychiatric disorders\n* Regular use of psychotropic medications\n* Cognitive or developmental disabilities that would interfere with assessments'}, 'identificationModule': {'nctId': 'NCT07124234', 'briefTitle': 'The Impact of Social Anxiety on Adolescents Diagnosed With Primary Headache: A Case-control Study', 'organization': {'class': 'OTHER', 'fullName': 'Konya Necmettin Erbakan Üniversitesi'}, 'officialTitle': 'Assessment of the Impact of Social Anxiety on Primary Headache in Adolescents: A Case-Control Study', 'orgStudyIdInfo': {'id': '2025001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case group', 'description': 'Participants who will be diagnosed with primary headache according to InternationalClassification of Headache Disorders, 3rd edition (ICHD-3) criteria, confirmed by a pediatric neurologist'}, {'label': 'Control group', 'description': 'Participants who will have no history of recurrent headache or chronic physical/psychiatricillness'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Fatma SARGIN, MD', 'role': 'CONTACT', 'email': 'fatmasargin@yahoo.com.tr', 'phone': '+905337263229'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'ipdSharing': 'YES', 'description': 'All de-identified individual participant data', 'accessCriteria': 'Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee\n\n• Requires a scientifically sound proposal or protocol\n\n• Requires approval by an ethics committee\n\n• Requires a data sharing agreement between data requester and trial custodian or sponsor'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konya Necmettin Erbakan Üniversitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Fatma SARGIN, M.D', 'investigatorAffiliation': 'Konya Necmettin Erbakan Üniversitesi'}}}}