AzTrials
AzTrials

MigraineAwarenessNCT06857383

Head Awareness in Chronic Migraine Patients

An observational study of Migraine, run by Bozok University at 13 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Research indicates that different beliefs about the nature of back problems and their future consequences direct behaviors that may cause falsely stimulated neuroplastic changes. The central nervous system can help relieve ongoing pain by regulating nociceptive activity. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Migraine
What is being tested?
Fremantle Headache Awareness Questionnaire
How many people
180 participants
Where
13 sitesin 2 countries
Study dates
2 Jan 2025to 30 May 2025
How long will I take part?
2 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients between the ages of 18 and 70 who applied to the Department of Neurology of Mersin University Faculty of Medicine and the Department of Neurology of Gazi University Faculty of Medicine and who were diagnosed with chronic migraine, according to the International Classification of Headache Disorders, 3rd Edition, by a neurologist who is an expert in the field of headache were included in the study.

Who may be able to join

  • Being diagnosed with chronic migraine
  • Being between the ages of 18-70,
  • Being able to read, speak, understand and write Turkish in order to understand the items/questions of the surveys and scales and to give correct answers.

Who cannot join

  • Having any headache diagnosis other than chronic migraine,
  • Having a history of any systemic disease such as malignant, inflammatory, acute fracture/infection, surgery, neurological, psychological, rheumatological.
  • Having neck or back pain

Trial locations and contacts

13 sites in 2 countries.

13 sites in 2 countries

Turkey (Türkiye)12 sites

  • Gazi University

    Ankara, Yenimahalle, 06560

  • Ankara Atatürk Sanatoryum Training and Research Hospital

    Ankara

  • Gazi University

    Ankara

  • Gaziantep City Hospital

    Gaziantep

  • İstanbul University

    Istanbul

  • Silivri State Hospital

    Istanbul

  • Kutahya Health Sciences University

    Kütahya

  • Mersin University

    Mersin, Yenisehir, 33100

  • Headache and Cognition Clinic of Aynur Ozge

    Mersin

  • Tokay Gaziosmanpaşa University

    Tokat Province

  • Bozok University

    Yozgat, Merkez, 66100

  • Zonguldak Bülent Ecevit University

    Zonguldak

Other trials in Turkey (Türkiye)

Cyprus1 site

  • Elite Research and Surgical Hospital

    Nicosia

Other trials in Cyprus

About this study

Official title: Assessment of Head Awareness in Chronic Migraine Patients With the Fremantle Headache Awareness Questionnaire: Turkish Version, Validity and Reliability Study

Research indicates that different beliefs about the nature of back problems and their future consequences direct behaviors that may cause falsely stimulated neuroplastic changes. The central nervous system can help relieve ongoing pain by regulating nociceptive activity. For this purpose, "The Fremantle Back Awareness Questionnaire" was developed to evaluate the perceptual awareness status of the back. In individuals with chronic pain, changes in body perception can be explained by the cortical reorganization that occurs in these individuals. Compared to healthy individuals, cortical thickness is reduced in the brain regions that process pain in chronic migraine patients. On the other hand, it is stated that these cortical structural changes can be reversed and recovery can be achieved by treating headache and related symptoms in chronic migraine patients. Individuals try to continue their daily lives with impaired body awareness due to pain. Decreased awareness has been studied in many neck, back and knee pain studies in the literature with Fremantle Awareness Questionnaires in different societies. In these studies, the awareness of individuals experiencing pain was found to be low and it was found that neck, waist or knee awareness was related to pain intensity, pain catastrophizing, disability, quality of life, anxiety, depression and kinesiophobia. It was even determined that awareness increased with treatments. Although reversible structural changes in the cortical regions of chronic migraine patients have been investigated with radiological imaging methods and are still being investigated, not every patient can be evaluated with radiological imaging in clinics due to cost and time problems. Therefore, a fast, practical and understandable questionnaire evaluation can benefit clinicians. When the literature is examined, there is no study evaluating the perceptual level and nociceptive awareness in chronic migraine headache. Conducting a validity and reliability study of the "Fremantle Headache Awareness Questionnaire" developed from The Fremantle Back Awareness Questionnaire in Turkish society can provide objective results in evaluating the effectiveness of treatment as a practical evaluation method in clinics. Hypotheses:

H0: The Fremantle Headache Awareness Questionnaire is not valid and reliable for the Turkish population in chronic migraine patients.

H1: The Fremantle Headache Awareness Questionnaire is valid and reliable for the Turkish population in chronic migraine patients.

Conditions
Migraine
Being tested
Fremantle Headache Awareness Questionnaire
Keywords
migraine, awareness, headache
Medical subject headings
Migraine Disorders, Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fremantle Headache Awareness QuestionnaireOther

    It is a simple Likert-type questionnaire that evaluates individual-specific altered perception (0 = Never/Never feel like this, 1 = Rarely feel like this, 2 = Sometimes or sometimes feel like this, 3 = Often feel like this, 4 = Always or most of the time feel like this). The questionnaire asks individuals 9 questions about how they perceive their heads and headaches in relation to their bodies. The questionnaire was developed by Wand et al. in its first version as "The Fremantle Back Awareness Questionnaire". With permission from the author, the questionnaire was created by adapting the questions of the Fremantle Back Awareness Questionnaire to headache.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Scale

    The visual analog scale consists of the pain level that the person currently experiences with a vertical line on a plane. The pain felt by the person is marked as "0: no pain at all", "10: I feel very severe pain". Scoring is based on the vertical marking the participant makes for the pain he/she marks on the plane with a ruler.

    Measured: In first enrollment, 1 minute

  2. Migraine Disability Assessment Questionnaire

    Disability of migraine patients will be assessed with the Migraine Disability Assessment Questionnaire (MEDA). MEDA assesses the last 3 months of disability and consists of a 5-item self-administered test covering disability-related activities at work/school, housework, family, and social or leisure. The total number of days missed in these activities is the total score and classifies disability as minimal disability (0-5 points), mild disability (6-10 points), moderate disability (11-20 points), or severe disability (≥21).

    Measured: In first enrollment, 3 minutes

  3. Headache Impact Test-6

    The impact of headache will be assessed with the Headache Impact Test-6 (HIT-6). HIT-6 is a quality of life questionnaire for headaches that assesses vitality, pain, psychological distress, sociability, role, and cognitive functioning. Each item is scored on a 5-point Likert scale (6=never, 8=rarely, 10=sometimes, 11=very often, 13=always). The total score is determined by summing the scores on the six items and ranges from 36 to 78 points. (≤49 = little/no impact, 50-55 = some impact, 56-59 = significant impact, and 60-78 = severe impact; higher scores indicate greater deterioration in quality of life).

    Measured: In first enrollment, 3 minutes

  4. Hospital Anxiety and Depression Scale

    Anxiety and depression will be assessed with the Hospital Anxiety and Depression Scale (HADS). 7 items of the 14-item scale assess anxiety and 7 items assess depression symptoms. It is scored between 0-3 points. By summing the subscale scores, 0-21 points can be obtained from each of the Depression and Anxiety subscales. It is stated that 0-7 points are the normal range for each subscale, 8-10 points suggest the presence of a mood disorder, and 11 and above points indicate a possible mood disorder. In addition, there are recommended cut-off scores for mild (8-10 points), moderate (11-15) and severe (16 and above) cases.

    Measured: In first enrollment, 3 minutes

  5. Pain Catastrophizing Scale

    A scale consisting of 13 items that evaluates negative thoughts and feelings about pain experienced. Each item is scored between "0-never and 4-always". The total score of the scale varies between 0-52 and an increase in score indicates a high level of pain catastrophizing. The scale consists of "Helplessness, Magnification, and Rumination" subscales.

    Measured: In first enrollment, 3 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2025
  2. Study start2 Jan 2025
  3. Primary completion28 May 2025
  4. Study completion30 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
180 participants (actual)
Target duration
2 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06857383
Sponsor's protocol ID
2024-GOKAEK2413_2024.11.20_191
Acronym
Awareness
Status last verified
Jul 2025
First submitted
26 Feb 2025
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Karakas Ugurlu G, Ugurlu M, Erten S, Can SS, Ulusoy Kaymak S, Caykoylu A. Effect of familial Mediterranean fever on sexual and reproductive health in women. Turk J Med Sci. 2017 Apr 18;47(2):463-469. doi: 10.3906/sag-1602-88.

    PubMed 28425232

  • Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.

    PubMed 12914662

  • Aydemir Ö, Güvenir T, Küey L, Kültür S. Hastane Anksiyete ve Depresyon Ölçeğinin Türkçe formunun geçerlik ve güvenilirlik çalışması. Türk Psikiyatri Dergisi 1997;8(4):280-287

  • Dikmen PY, Bozdag M, Gunes M, Kosak S, Tasdelen B, Uluduz D, Ozge A. Reliability and Validity of Turkish Version of Headache Impact Test (HIT-6) in Patients with Migraine. Noro Psikiyatr Ars. 2020 Apr 24;58(4):300-307. doi: 10.29399/npa.24956. eCollection 2021.

    PubMed 34924791

  • Ertas M, Siva A, Dalkara T, Uzuner N, Dora B, Inan L, Idiman F, Sarica Y, Selcuki D, Sirin H, Oguzhanoglu A, Irkec C, Ozmenoglu M, Ozbenli T, Ozturk M, Saip S, Neyal M, Zarifoglu M; Turkish MIDAS group. Validity and reliability of the Turkish Migraine Disability Assessment (MIDAS) questionnaire. Headache. 2004 Sep;44(8):786-93. doi: 10.1111/j.1526-4610.2004.04146.x.

    PubMed 15330825

  • Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.

    PubMed 6226917

  • Lai KL, Niddam DM, Fuh JL, Chen WT, Wu JC, Wang SJ. Cortical morphological changes in chronic migraine in a Taiwanese cohort: Surface- and voxel-based analyses. Cephalalgia. 2020 May;40(6):575-585. doi: 10.1177/0333102420920005. Epub 2020 Apr 16.

    PubMed 32299230

  • Onan D, Gokmen D, Ulger O. The Fremantle Neck Awareness Questionnaire in Chronic Neck Pain Patients: Turkish Version, Validity and Reliability Study. Spine (Phila Pa 1976). 2020 Feb 1;45(3):E163-E169. doi: 10.1097/BRS.0000000000003207.

    PubMed 31425430

  • Wand BM, Catley MJ, Rabey MI, O'Sullivan PB, O'Connell NE, Smith AJ. Disrupted Self-Perception in People With Chronic Low Back Pain. Further Evaluation of the Fremantle Back Awareness Questionnaire. J Pain. 2016 Sep;17(9):1001-12. doi: 10.1016/j.jpain.2016.06.003. Epub 2016 Jun 18.

    PubMed 27327235

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine, run by Bozok University at 13 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Turkey (Türkiye), Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (time frame: In first enrollment, 1 minute). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06857383, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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