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NCT Number: NCT07038499

Prevalence and Determinants of Migraine Among Headache Patients

Migraine is a prevalent and disabling neurological condition that often coexists with other health issues, such as hypertension and impaired physical, mental, and social functioning. Understanding the prevalence of migraine and its associations with these health domains can provide valuable insights into the broader impact of migraine on overall well-being. By focusing on patients at the Affiliated Hospital of Hebei University of Engineering in China, this study can identify specific health burdens within this population, inform integrated clinical management strategies, and support the development of targeted interventions to improve patient outcomes and quality of life.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Affiliated Hospital of Hebei University of Engineering, China

Hebei, China

Location contact

Shi Yuping

PRINCIPAL_INVESTIGATOR

Yuping Student

CONTACT

[email protected]

About this study

Migraine is a common and disabling neurological disorder that poses a significant public health burden worldwide. In China, the estimated prevalence of migraine is approximately 9.3%, with higher rates reported among women and individuals of working age. Despite being one of the most prevalent types of primary headache disorders, migraine remains underdiagnosed and undertreated in many regions of China, partly due to limited awareness and access to specialized care. Concurrently, hypertension is highly prevalent in the Chinese adult population, with nearly one in four adults affected, making it a leading contributor to cardiovascular morbidity. Emerging evidence suggests a potential bidirectional relationship between migraine and hypertension, possibly linked through shared pathophysiological mechanisms such as endothelial dysfunction, autonomic dysregulation, and inflammatory pathways.

Moreover, migraine is often associated with detrimental effects on physical, mental, and social health, including impaired physical function, increased pain intensity, depression, anxiety, fatigue, sleep disturbances, and reduced ability to participate in social roles and activities. However, studies exploring these multidimensional impacts in Chinese clinical populations remain limited.

Therefore, this study aims to investigate the prevalence of migraine and its association with hypertension as well as physical, mental, and social health domains among headache patients at the Affiliated Hospital of Hebei University of Engineering, China.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with headache according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3).

Exclusion criteria

  • Patients with other major diseases or severe mental disorders;
  • History of endocrine, immune, or nervous system diseases or other severe somatic diseases.

Treatment and study plan

Primary outcomes

  1. Prevalence of migraine

    Time frame: Day 1

    The overall number and proportion of people with migraine (according to the International Classification of Headache Disorders, 3rd edition (ICHD-3))

Secondary outcomes

  1. Correlation with hypertension

    Time frame: Day 1

    Hypertension will be assessed using self-reported hypertension status (Yes/ No)

  2. Correlation with physical (physical function, pain intensity), mental (depression, anxiety, fatigue, sleep disturbance) and social (ability to participate in social roles and activities)

    Time frame: Day 1

    Patient-Reported Outcomes Measurement Information System (PROMIS) measures domains including physical (physical function, pain intensity), mental (depression, anxiety, fatigue, sleep disturbance) and social (ability to participate in social roles and activities). The total score of each domain is converted to a standardized T score. High scores mean more of the domains being measured.

  3. Correlation with migraine disability

    Time frame: Day 1

    The MIDAS (Migraine Disability Assessment) is a validated questionnaire used to measure headache-related disability over the past three months. It consists of five questions, each addressing the number of days affected by migraines. Each answer is recorded as a number of days. The higher score indicating more severe migraine disability

  4. Correlation with quality of life

    Time frame: Day 1

    The Migraine-Specific Quality of Life Questionnaire (MSQ) is a validated tool used to assess the impact of migraine on a patient's quality of life. Raw scores are first calculated by summing item responses for each domain. Raw scores are then transformed into a 0-100 scale, where higher scores indicate better quality of life.

Study contacts

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

Chai Nien Associate Professor, PhD

CONTACT

[email protected]

+60123167252

Chai Nien Associate Professor, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Universiti Tunku Abdul Rahman

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2025
Registry last updated
Jun 26, 2025

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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