MigraineNCT07822386
Migraine Characteristics and Associated Factors
An observational study of Migraine, run by Lokman Hekim University.
Trial summary
This cross-sectional study aims to evaluate the clinical characteristics of migraine and factors associated with migraine-related disability and impact in adults diagnosed with primary migraine. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Migraine
- What is being tested?
- Observational assessment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Dec 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of adults aged 18 years or older who have been diagnosed with primary migraine by a neurologist. Individuals who meet the study eligibility criteria and voluntarily agree to participate will be recruited through study announcements shared via social media platforms, including LinkedIn, WhatsApp, and Instagram. Eligible participants will be invited to Lokman Hekim University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, where all study assessments will be conducted face to face. The study population will include individuals with different clinical characteristics of migraine in order to evaluate migraine-related disability, headache impact, associated symptoms, lifestyle-related factors, and physical examination findings.
Who may be able to join
- Aged 18 years or older
- Diagnosed with primary migraine by a neurologist
- Having a history of migraine for at least 3 months
- Able to understand and complete the study questionnaires and assessments
- Willing to participate voluntarily in the study
Who cannot join
- Presence of a secondary headache disorder
- Presence of another neurological or systemic condition that may substantially affect headache characteristics or interfere with the study assessments
- Presence of a cognitive or communication impairment that prevents reliable completion of the questionnaires
- Incomplete completion of the study assessments or questionnaires
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: Evaluation of Clinical Characteristics of Migraine and Associated Factors in Individuals Diagnosed With Primary Migraine
This cross-sectional study aims to evaluate the clinical characteristics of migraine and factors associated with migraine-related disability and impact in adults diagnosed with primary migraine. Participants will complete questionnaires assessing sociodemographic and lifestyle characteristics, headache features, neck pain, sleep quality, fatigue, migraine-related disability, and the impact of headache on daily life. Migraine-related disability will be assessed using the Migraine Disability Assessment Scale (MIDAS), and headache impact will be assessed using the Headache Impact Test-6 (HIT-6). In addition, participants will undergo a physical examination including assessment of tender points. The study will investigate the relationships between migraine-related outcomes and clinical and lifestyle factors. No treatment or therapeutic intervention will be administered as part of the study.
Read the detailed description
Migraine is a common neurological condition that may substantially affect daily functioning, work or school performance, social participation, and quality of life. The burden of migraine may be influenced not only by headache intensity and frequency but also by associated clinical and lifestyle factors.
This cross-sectional study is designed to characterize migraine-related symptoms and to examine factors associated with migraine-related disability and headache impact in adults with a diagnosis of primary migraine. Data will be collected during a single face-to-face assessment. Participants will complete self-reported measures covering sociodemographic and lifestyle characteristics, headache features, associated symptoms, neck pain, perceived sleep quality, fatigue, migraine-related disability, and the impact of headache on daily life. A physical examination will also be performed to assess predefined tender points.
The study will explore the relationships between migraine-related outcomes and selected clinical and lifestyle characteristics. No therapeutic intervention will be administered, and participation will involve assessment procedures only.
- Conditions
- Migraine
- Being tested
- Observational assessment
- Keywords
- migraine, headache
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational assessmentOther
Participants completed assessment form. No intervention was administered.
| Study group | Role | What they receive |
|---|---|---|
| Individuals With Primary Migraine | Adults diagnosed with primary migraine who meet the study eligibility criteria and undergo the study assessments, including questionnaires evaluating migraine characteristics, migraine-related disability, headache impact, neck pain, sleep quality, fatigue, and lifestyle-related factors, as well as tender point examination. No therapeutic intervention will be administered. Receives: Other: Observational assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Migraine-Related Disability
Migraine-related disability will be assessed using the Migraine Disability Assessment Scale (MIDAS). The MIDAS consists of five items evaluating the number of days over the previous 3 months in which headache caused missed or substantially reduced productivity in work/school, household activities, and family/social/leisure activities. The total score is calculated by summing the number of days reported across the five items, with higher scores indicating greater migraine-related disability.
Measured: Baseline
Secondary outcomes (6)
Headache Impact
Headache impact will be assessed using the Headache Impact Test-6 (HIT-6). The HIT-6 consists of six items evaluating the impact of headache on daily activities, fatigue, emotional well-being, and concentration. The total score ranges from 36 to 78, with higher scores indicating a greater impact of headache on daily life.
Measured: Baseline
Headache Pain Intensity
Headache pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates unbearable pain. Higher scores indicate greater headache intensity.
Measured: Baseline
Neck Pain Intensity
Neck pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates unbearable pain. Higher scores indicate greater neck pain intensity.
Measured: Baseline
Perceived Sleep Quality
Perceived sleep quality will be assessed using a 10-cm Visual Analog Scale. Participants will rate their sleep quality from 0 to 10, with higher scores indicating better perceived sleep quality.
Measured: Baseline
Daily Step Count
Daily physical activity will be represented by the participant's average daily step count obtained from personal devices such as smartphones or wearable activity trackers.
Measured: Baseline
Presence of Associated Migraine Symptoms
The presence of migraine-associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia, dizziness, and imbalance, will be recorded based on participant self-report.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Demet Öztürk, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822386
- Sponsor's protocol ID
- 2026-BA
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Characteristics of Migraine and Associated Factors in Individuals Diagnosed With Primary Migraine
- ClinicalTrials.gov ID
- NCT07822386
- Acronym / sponsor ID
- 2026-BA
- Conditions
- Migraine
- Keywords
- migraine, headache
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Sep 2026 (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 cross-sectional study aims to evaluate the clinical characteristics of migraine and factors associated with migraine-related disability and impact in adults diagnosed with primary migraine. Participants will complete questionnaires assessing sociodemographic and lifestyle characteristics, headache features, neck pain, sleep quality, fatigue, migraine-related disability, and the impact of headache on daily life. Migraine-related disability will be assessed using the Migraine Disability Assessment Scale (MIDAS), and headache impact will be assessed using the Headache Impact Test-6 (HIT-6). In addition, participants will undergo a physical examination including assessment of tender points. The study will investigate the relationships between migraine-related outcomes and clinical and lifestyle factors. No treatment or therapeutic intervention will be administered as part of the study.
Detailed description
Migraine is a common neurological condition that may substantially affect daily functioning, work or school performance, social participation, and quality of life. The burden of migraine may be influenced not only by headache intensity and frequency but also by associated clinical and lifestyle factors.
This cross-sectional study is designed to characterize migraine-related symptoms and to examine factors associated with migraine-related disability and headache impact in adults with a diagnosis of primary migraine. Data will be collected during a single face-to-face assessment. Participants will complete self-reported measures covering sociodemographic and lifestyle characteristics, headache features, associated symptoms, neck pain, perceived sleep quality, fatigue, migraine-related disability, and the impact of headache on daily life. A physical examination will also be performed to assess predefined tender points.
The study will explore the relationships between migraine-related outcomes and selected clinical and lifestyle characteristics. No therapeutic intervention will be administered, and participation will involve assessment procedures only.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals With Primary Migraine | – | Other: Observational assessmentAdults diagnosed with primary migraine who meet the study eligibility criteria and undergo the study assessments, including questionnaires evaluating migraine characteristics, migraine-related disability, headache impact, neck pain, sleep quality, fatigue, and lifestyle-related factors, as well as tender point examination. No therapeutic intervention will be administered. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of adults aged 18 years or older who have been diagnosed with primary migraine by a neurologist. Individuals who meet the study eligibility criteria and voluntarily agree to participate will be recruited through study announcements shared via social media platforms, including LinkedIn, WhatsApp, and Instagram. Eligible participants will be invited to Lokman Hekim University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, where all study assessments will be conducted face to face. The study population will include individuals with different clinical characteristics of migraine in order to evaluate migraine-related disability, headache impact, associated symptoms, lifestyle-related factors, and physical examination findings.
Key inclusion criteria (5 listed)
- Aged 18 years or older
- Diagnosed with primary migraine by a neurologist
- Having a history of migraine for at least 3 months
- Able to understand and complete the study questionnaires and assessments
- Willing to participate voluntarily in the study
Key exclusion criteria (4 listed)
- Presence of a secondary headache disorder
- Presence of another neurological or systemic condition that may substantially affect headache characteristics or interfere with the study assessments
- Presence of a cognitive or communication impairment that prevents reliable completion of the questionnaires
- Incomplete completion of the study assessments or questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational assessmentParticipants completed assessment form. No intervention was administered. | Other | Individuals With Primary Migraine |
Primary outcome
Migraine-Related Disability
Time frame: Baseline
Migraine-related disability will be assessed using the Migraine Disability Assessment Scale (MIDAS). The MIDAS consists of five items evaluating the number of days over the previous 3 months in which headache caused missed or substantially reduced productivity in work/school, household activities, and family/social/leisure activities. The total score is calculated by summing the number of days reported across the five items, with higher scores indicating greater migraine-related disability.
6 secondary outcomes
Headache Impact
Time frame: Baseline
Headache Pain Intensity
Time frame: Baseline
Neck Pain Intensity
Time frame: Baseline
Perceived Sleep Quality
Time frame: Baseline
Daily Step Count
Time frame: Baseline
Presence of Associated Migraine Symptoms
Time frame: Baseline
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 16 Sep 2026.
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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 Migraine, run by Lokman Hekim University.
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 5 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 16 Sep 2026. 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 Demet Öztürk, Phd (05068394288, demett.ozturkk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Migraine-Related Disability (time frame: Baseline). 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 16 Sep 2026.