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

NCT07843745 | Not Yet Recruiting

• 1 other identifier: Approval Νο: 702, 3-6-2026
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Migraine

Keywords

migraine; headache; head awareness; disability; quality of life

Outcome Measures

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.

  Baseline and 1 week for test-retest reliability

Secondary Outcomes (4)

• Headache Intensity

  Baseline

• Migraine-Related Disability

  Baseline

• Headache Impact

  Baseline

• Migraine-Specific Quality of Life

  Baseline

Study Arms (1)

Individuals With Migraine

Individuals diagnosed with migraine who will participate in the cross-cultural adaptation and psychometric evaluation of the Greek version of the Fremantle Headache Awareness Questionnaire (FreHAQ-GR).

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• Presence of a headache disorder other than migraine
• History of systemic diseases, including malignant, inflammatory, acute traumatic, infectious, surgical, neurological, psychiatric, or rheumatological conditions

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

National Kapodistrian University of Athens, Aeginition Hospital, Headache Clinic

Athens, Attica, 11528, Greece

Location

Related Publications (21)

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michalis Kodounis, Neurologist, PhD

CONTACT

+30 697 3600069; kodounis@gmail.com

Dimos Mitsikostas, Neurologist, PhD

CONTACT

dimosmitsikostas@me.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Neurologist, Medical Doctor

Study Record Dates

• First Submitted: September 21, 2026
• First Posted: September 28, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)