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临床试验/NCT07124234
NCT07124234尚未招募不适用

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

Konya Necmettin Erbakan Üniversitesi0 个研究点目标入组 200 人开始时间: 2025年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
主要终点
Total score on the Social Anxiety Scale for Adolescents (SAS-A)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

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

时间窗: Day 1

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

次要结局

  • Prevalence of clinically significant social anxiety (SAS-A = 50)(Day 1)
  • Body Mass Index (BMI) differences between groups(Day 1)
  • Parental smoking status(Day 1)

研究者

发起方
Konya Necmettin Erbakan Üniversitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatma SARGIN, M.D

MD

Konya Necmettin Erbakan Üniversitesi

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