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Migraine Characteristics and Associated Factors

2026年9月10日 更新者:Demet Öztürk、Lokman Hekim University

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.

研究概览

地位

尚未招聘

条件

详细说明

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.

研究类型

观察性的

注册 (估计的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Migraine-Related Disability
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Headache Impact
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2026年11月1日

研究完成 (估计的)

2026年12月1日

研究注册日期

首次提交

2026年9月10日

首先提交符合 QC 标准的

2026年9月10日

首次发布 (实际的)

2026年9月16日

研究记录更新

最后更新发布 (实际的)

2026年9月16日

上次提交的符合 QC 标准的更新

2026年9月10日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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