- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07822386
Migraine Characteristics and Associated Factors
Evaluation of Clinical Characteristics of Migraine and Associated Factors in Individuals Diagnosed With Primary Migraine
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Demet Öztürk, Phd
- Phone Number: 05068394288
- Email: demett.ozturkk@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Participants completed assessment form.
No intervention was administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
|
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.
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-BA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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