NCT06857383: Awareness

Head Awareness in Chronic Migraine Patients

Completed Last updated 8 July 2025

What this trial tests

trial testing Fremantle Headache Awareness Questionnaire in Migraine in 180 participants. Completed in 30 May 2025.

Timeline

2 January 2025

Primary endpoint
28 May 2025

30 May 2025

Quick facts

Lead sponsor	Bozok University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	180
Start date	2 January 2025
Primary completion	28 May 2025
Estimated completion	30 May 2025
Sites	13 locations across Turkey (Türkiye), Cyprus

Drugs / interventions tested

• Fremantle Headache Awareness Questionnaire

Conditions studied

• Migraine — all drugs for Migraine →

Sponsor

Bozok University

Who can join

Adults 18 to 70, any sex, with Migraine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Assessment of Head Awareness in Patients with Chronic Migraine Using the Fremantle Headache Awareness Questionnaire: Turkish Version, Validity, and Reliability Study.
   Onan D, Arıkan H, Vurallı D, Akgör MC, et al · · 2026 · PMID 41777502 · DOI 10.29399/npa.29190