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Migraine Characteristics and Associated Factors

Evaluation of Clinical Characteristics of Migraine and Associated Factors in Individuals Diagnosed With Primary Migraine

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07822386
Enrollment
100
Registered
2026-09-16
Start date
2026-10-01
Completion date
2026-12-01
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

migraine, headache

Brief 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. 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.

Interventions

OTHERObservational assessment

Participants completed assessment form. No intervention was administered.

Sponsors

Lokman Hekim University
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Migraine-Related DisabilityBaselineMigraine-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.

Secondary

MeasureTime frameDescription
Headache ImpactBaselineHeadache 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.
Headache Pain IntensityBaselineHeadache 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.
Neck Pain IntensityBaselineNeck 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.
Perceived Sleep QualityBaselinePerceived 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.
Daily Step CountBaselineDaily physical activity will be represented by the participant's average daily step count obtained from personal devices such as smartphones or wearable activity trackers.
Presence of Associated Migraine SymptomsBaselineThe presence of migraine-associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia, dizziness, and imbalance, will be recorded based on participant self-report.

Contacts

CONTACTDemet Öztürk, Phd
demett.ozturkk@gmail.com05068394288

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026