An observational study in Migraine, sponsored by National and Kapodistrian University of Athens. Not yet recruiting at 1 site in Greece. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by National and Kapodistrian University of Athens · Observational
Migraine is a common neurological disorder that can significantly affect daily activities, quality of life, and emotional well-being. How individuals think and feel about pain may also influence their experience of migraine. Pain catastrophizing refers to an exaggerated negative response to pain, including persistent worry about pain and feelings of helplessness.
The Pain Catastrophizing Scale (PCS) is a commonly used questionnaire for assessing pain catastrophizing. However, the psychometric properties of the Greek version of the PCS have not been adequately evaluated in people with migraine.
This study aims to evaluate the validity and reliability of the Greek version of the Pain Catastrophizing Scale in patients with migraine. The study will determine whether the Greek PCS can be used as an appropriate tool for assessing pain catastrophizing in the Greek migraine population.
Migraine is a common and highly burdensome neurological disorder that significantly affects patients' quality of life, functioning, and psychosocial well-being [1]. In people with migraine, the overall burden of the disease is determined not only by pain intensity and frequency but also by cognitive and emotional factors related to the perception and management of pain [1,2]. Of particular interest is pain catastrophizing, a maladaptive cognitive state in which the individual perceives pain as excessively threatening, persistently focuses on it, and experiences feelings of helplessness or powerlessness in response to it [3].
The literature has shown that high levels of pain catastrophizing in patients with migraine are associated with greater pain intensity, increased migraine-related disability, and higher levels of anxiety and depression [2-4]. In addition, pain catastrophizing has been reported to play an important role in migraine chronicity and in the overall deterioration of patients' quality of life [5,6].
The Pain Catastrophizing Scale (PCS) is one of the most widely used instruments for assessing pain catastrophizing, and validity and reliability studies have been conducted in many different languages [7-9]. However, available data on the psychometric properties of the Greek version of the PCS in patients with migraine remain limited. A culturally adapted, valid, and reliable Greek version of the scale is particularly important because it may contribute substantially to improving clinical assessment, strengthening research activity, and implementing a comprehensive approach to migraine management.
Therefore, the aim of the present study is the cultural adaptation of the Greek version of the Pain Catastrophizing Scale in patients with migraine and the evaluation of its psychometric properties.
Aim of the study - Hypotheses to be tested The aim of the present study is to examine the validity and reliability of the Greek version of the Pain Catastrophizing Scale in Greek patients with migraine.
Hypotheses:
The study population will consist of adults aged 18-70 years with episodic or chronic migraine diagnosed by a neurologist according to the International Classification of Headache Disorders, 3rd edition (ICHD-3). Participants will be recruited from the Headache Outpatient Clinic of Aeginition Hospital, National and Kapodistrian University of Athens, Greece. Eligible participants must be able to understand, read, write, and speak Greek.
Exclusion Criteria:
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), who are able to understand, read, write, and speak Greek. Participants will complete the Greek version of the Pain Catastrophizing Scale (PCS) and other study questionnaires for psychometric evaluation. No intervention will be administered.
Pain Catastrophizing Scale
The psychometric properties of the Greek version of the Pain Catastrophizing Scale (PCS) will be evaluated in patients with migraine. The PCS consists of 13 items scored from 0 (never) to 4 (always), with a total score ranging from 0 to 52. Higher scores indicate greater pain catastrophizing. Reliability will be assessed using internal consistency and test-retest reliability.
Time frame: Baseline and 7-14 days after baseline for test-retest reliability.
Migraine Disability Assessment
Migraine-related disability will be assessed using the MIDAS questionnaire. The total score is based on days of activity lost because of headache during the previous 3 months. Higher scores indicate greater migraine-related disability.
Time frame: Baseline
Headache Impact
Headache-related impact on daily functioning and quality of life will be assessed using the HIT-6. Total scores range from 36 to 78, with higher scores indicating greater headache impact.
Time frame: Baseline
Migraine-Specific Quality of Life
Migraine-specific quality of life will be assessed using the 14-item MSQv2.1, which includes Role Function-Restrictive, Role Function-Preventive, and Emotional Function domains. Scores are transformed to a 0-100 scale, with higher scores indicating better migraine-specific quality of life.
Time frame: Baseline
Headache Pain Intensity
Headache pain intensity will be assessed using the VAS, ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Time frame: Baseline
Plan to share: Undecided — The decision regarding the sharing of individual participant data (IPD) has not yet been finalized. Data sharing may be considered upon reasonable request following study completion, subject to participant confidentiality, ethical requirements, and applicable data protection regulations.
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National and Kapodistrian University of Athens