The Impact of Social Anxiety on Adolescents Diagnosed With Primary Headache: A Case-control Study

NCT ID: NCT07124234

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-15

Study Completion Date

2025-10-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Headache Social Anxiety Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Control group

Participants who will have no history of recurrent headache or chronic physical/psychiatricillness

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adolescents aged 12-18 years
* 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

Exclusion Criteria

* History of neurological disease other than primary headache
* Any previously diagnosed psychiatric disorders
* Regular use of psychotropic medications
* Cognitive or developmental disabilities that would interfere with assessments
Minimum Eligible Age

12 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Konya Necmettin Erbakan Üniversitesi

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fatma SARGIN, M.D

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Fatma SARGIN, MD

Role: CONTACT

+905337263229

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Migraine in Adolescents
NCT05654012 RECRUITING NA
Oxygen Therapy for Headache
NCT05511155 COMPLETED