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NCT Number: NCT07124234

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

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Total score on the Social Anxiety Scale for Adolescents (SAS-A)

    Time frame: Day 1

    The SAS-A, a self-administered 22-item Likert-scale questionnaire

Secondary outcomes

  1. Prevalence of clinically significant social anxiety (SAS-A = 50)

    Time frame: Day 1

    Classification based on SAS-A total score cut-off

  2. Body Mass Index (BMI) differences between groups

    Time frame: Day 1

    BMI calculated as kg/m²

  3. Parental smoking status

    Time frame: Day 1

    Self-report from caregiver; statistical comparison of SAS-A scores by smoking exposure

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma SARGIN, MD

CONTACT

[email protected]

+905337263229

Sponsors and collaborators

Lead sponsor

Konya Necmettin Erbakan Üniversitesi

Other

Registry information

Official study title

Assessment of the Impact of Social Anxiety on Primary Headache in Adolescents: A Case-Control Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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