- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07822386
Migraine Characteristics and Associated Factors
Evaluation of Clinical Characteristics of Migraine and Associated Factors in Individuals Diagnosed With Primary Migraine
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Demet Öztürk, Phd
- Numero di telefono: 05068394288
- Email: demett.ozturkk@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Migraine-Related Disability
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Headache Impact
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026-BA
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .