Primary HeadacheNCT07124234
The Impact of Social Anxiety on Adolescents Diagnosed With Primary Headache: A Case-control Study
An observational study of Primary Headache and Social Anxiety Disorder, run by Konya Necmettin Erbakan Üniversitesi.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Primary Headache, Social Anxiety Disorder
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 15 Oct 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of the Impact of Social Anxiety on Primary Headache in Adolescents: 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.
Read the 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.
- Conditions
- Primary Headache, Social Anxiety Disorder
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score on the Social Anxiety Scale for Adolescents (SAS-A)
The SAS-A, a self-administered 22-item Likert-scale questionnaire
Measured: Day 1
Secondary outcomes (3)
Prevalence of clinically significant social anxiety (SAS-A = 50)
Classification based on SAS-A total score cut-off
Measured: Day 1
Body Mass Index (BMI) differences between groups
BMI calculated as kg/m²
Measured: Day 1
Parental smoking status
Self-report from caregiver; statistical comparison of SAS-A scores by smoking exposure
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma SARGIN, M.D, Konya Necmettin Erbakan Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124234
- Sponsor's protocol ID
- 2025001
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of Social Anxiety on Primary Headache in Adolescents: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07124234
- Acronym / sponsor ID
- 2025001
- Conditions
- Primary Headache, Social Anxiety Disorder
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: Yes. All de-identified individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Headache and Social Anxiety Disorder, run by Konya Necmettin Erbakan Üniversitesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma SARGIN, MD (+905337263229, fatmasargin@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score on the Social Anxiety Scale for Adolescents (SAS-A) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.