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

NCT07124234 | Not Yet Recruiting

• 1 other identifier: 2025001
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Primary Headache; Social Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

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

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

  Day 1

Secondary Outcomes (3)

• 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

Study Arms (2)

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

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya Necmettin Erbakan Üniversitesi: lead

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Central Study Contacts

Fatma SARGIN, MD

CONTACT

+905337263229; fatmasargin@yahoo.com.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 15, 2025
• Study Start: August 15, 2025
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Access Criteria: Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee • Requires a scientifically sound proposal or protocol • Requires approval by an ethics committee • Requires a data sharing agreement between data requester and trial custodian or sponsor