The Impact of Social Anxiety on Adolescents Diagnosed With Primary Headache: A Case-control Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Primary Headache, Social Anxiety Disorder. Basic parameters: 12 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessment of the Impact of Social Anxiety on Primary Headache in Adolescents: A Case-Control Study
Overview
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
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.
Primary outcome measures
- Total score on the Social Anxiety Scale for Adolescents (SAS-A) [Time frame: Day 1]
Secondary outcome measures (3)
- Prevalence of clinically significant social anxiety (SAS-A = 50) [Time frame: Day 1]
- Body Mass Index (BMI) differences between groups [Time frame: Day 1]
- Parental smoking status [Time frame: Day 1]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07124234 · 2025001