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NCT Number: NCT07822386

Migraine Characteristics and Associated Factors

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational Assessment

Other

Participants completed assessment form. No intervention was administered.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Headache Impact

    Time frame: Baseline

    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.

  2. Headache Pain Intensity

    Time frame: Baseline

    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.

  3. Neck Pain Intensity

    Time frame: Baseline

    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.

  4. Perceived Sleep Quality

    Time frame: Baseline

    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.

  5. Daily Step Count

    Time frame: Baseline

    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.

  6. Presence of Associated Migraine Symptoms

    Time frame: Baseline

    The presence of migraine-associated symptoms, including nausea, vomiting, photophobia, phonophobia, osmophobia, dizziness, and imbalance, will be recorded based on participant self-report.

Study contacts

Contact information is provided by the study sponsor or research team.

Demet Öztürk, Phd

CONTACT

[email protected]

05068394288

Sponsors and collaborators

Lead sponsor

Lokman Hekim University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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