Assessment of Head Awareness in Patients With Migraine in the Greek Population

ConditionMigraine
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorNational and Kapodistrian University of Athens

About this trial

Body perception and awareness may be altered in individuals with chronic pain and may be associated with pain intensity, disability, and pain-related psychological factors. Although alterations in pain processing and cortical organization have been reported in individuals with migraine, head-related perceptual awareness has received limited attention, and practical tools for its assessment are lacking.

The Fremantle Headache Awareness Questionnaire (FreHAQ) was developed to assess altered perception and awareness of the head in individuals with headache. A valid and reliable Greek version of this questionnaire could provide clinicians and researchers with a simple and practical tool for evaluating head awareness in individuals with migraine.

The primary aim of this study is to translate and culturally adapt the Fremantle Headache Awareness Questionnaire into Greek and to evaluate the validity and reliability of the Greek version in individuals with migraine. The study will examine the psychometric properties of the questionnaire, including its reliability and validity. Associations between head awareness and relevant clinical and pain-related characteristics will also be investigated.

This study is expected to determine whether the Greek version of the Fremantle Headache Awareness Questionnaire is an appropriate tool for assessing head awareness in the Greek migraine population.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of episodic or chronic migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), confirmed by a specialist neurologist

Age between 18 and 70 years

Ability to understand, read, write, and speak Greek

Disqualifiers

Presence of a headache disorder other than migraine

History of systemic diseases, including malignant, inflammatory, acute traumatic, infectious, surgical, neurological, psychiatric, or rheumatological conditions

Trial population

Adults aged 18-70 years with a diagnosis of episodic or chronic migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), confirmed by a specialist neurologist. Participants will be recruited from the Specialized Headache Clinic of Aeginition Hospital in Greece.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

90 Participants
are grouped into 1 trial group
Group A: Individuals With Migraine

Trial outcomes

Primary outcomes

1

Greek Version of the Fremantle Headache Awareness Questionnaire

The psychometric properties of the Greek version of the Fremantle Headache Awareness Questionnaire (FreHAQ-GR) will be evaluated in individuals with migraine. Reliability will be assessed using internal consistency and test-retest reliability. Validity will be evaluated through appropriate construct validity analyses and associations with related clinical measures. Higher FreHAQ scores indicate greater disturbance in head awareness.

Time frame
Baseline and 1 week for test-retest reliability

Secondary outcomes

1

Headache Intensity

Headache pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.

Time frame
Baseline
2

Migraine-Related Disability

Migraine-related disability will be assessed using the Migraine Disability Assessment (MIDAS), which evaluates days of lost or reduced activity due to migraine during the previous 3 months. Higher scores indicate greater migraine-related disability.

Time frame
Baseline
3

Headache Impact

The impact of headache on daily functioning and quality of life will be assessed using the six-item Headache Impact Test (HIT-6). Total scores range from 36 to 78, with higher scores indicating greater headache impact.

Time frame
Baseline
4

Migraine-Specific Quality of Life

Migraine-specific quality of life will be assessed using the 14-item Migraine-Specific Quality of Life Questionnaire Version 2.1 (MSQv2.1), covering Role Function-Restrictive, Role Function-Preventive, and Emotional Function domains. Scores are transformed to a 0-100 scale, with higher scores indicating better migraine-related quality of life.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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