- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07822386
Migraine Characteristics and Associated Factors
Evaluation of Clinical Characteristics of Migraine and Associated Factors in Individuals Diagnosed With Primary Migraine
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Demet Öztürk, Phd
- Telefonní číslo: 05068394288
- E-mail: demett.ozturkk@gmail.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Migraine-Related Disability
Časové okno: 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.
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Baseline
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Headache Impact
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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Presence of Associated Migraine Symptoms
Časové okno: 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
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026-BA
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