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Not yet recruitingNCT07847528Updated Sep 29, 2026

Validity and Reliability of the Greek Pain Catastrophizing Scale

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

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
130
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the detailed description

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:

  • H0: The Pain Catastrophizing Scale is not valid and reliable for patients with migraine in the Greek population.
  • H1: The Pain Catastrophizing Scale is valid and reliable for patients with migraine in the Greek population.
02

Conditions studied

  • Migraine

Keywords

  • migraine
  • headache
  • pain catastrophizing
  • disability
  • quality of life
  • headache intensity
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Inclusion criteria

  • Diagnosis of migraine
  • Age 18-70 years
  • Ability to understand, read, write, and speak the Greek language

Exclusion criteria

Exclusion Criteria:

  • Presence of a headache disorder other than migraine
  • History of systemic diseases (malignant, inflammatory, acute traumatic, infectious, surgical, neurological, psychiatric, or rheumatological conditions)
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
130 participants (estimated)
Target follow-up
1 Week
Patient registry
Yes

Groups and cohorts

  • Patients with Migraine

    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.

05

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

06

Study locations

1 site
  • National Kapodistrian University of Athens, Aeginition Hospital, Headache Clinic
    Athens, Attica 11528, Greece
07

References and documents

Publications

  • Onan D, Arikan H, Vuralli D, Akgor MC, Pala AB, Yanik E, Can AI, Ulutas C, Yesildas PY, Yildirim I, Gelener P, Demirel EA, Ekizoglu E, Ozge A. Assessment of Head Awareness in Patients with Chronic Migraine Using the Fremantle Headache Awareness Questionnaire: Turkish Version, Validity, and Reliability Study. Noro Psikiyatr Ars. 2025 Sep 19;63:308-315. doi: 10.29399/npa.29190. eCollection 2026. PubMed 41777502 ↗
  • 17. Portney, L.G., Foundations of clinical research: applications to evidence-based practice. 2020: FA Davis.
  • Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available. PubMed 11124735 ↗
  • 15. Sullivan, M.J., S.R. Bishop, and J. Pivik, The pain catastrophizing scale: development and validation. Psychological assessment, 1995. 7(4): p. 524.
  • Giannouli E, Giannouli E, Alexoudi A, Arvaniti C, Fakas N, Constantinidis TS, Kouremenos E, Mitsikostas DD; Hellenic Headache Society. Validity and reliability of the Greek Migraine-Specific Quality of Life Questionnaire (MSQ Version 2.1-GR). J Patient Rep Outcomes. 2024 Jul 15;8(1):72. doi: 10.1186/s41687-024-00762-4. PubMed 39007966 ↗
  • Martin M, Blaisdell B, Kwong JW, Bjorner JB. The Short-Form Headache Impact Test (HIT-6) was psychometrically equivalent in nine languages. J Clin Epidemiol. 2004 Dec;57(12):1271-8. doi: 10.1016/j.jclinepi.2004.05.004. PubMed 15617953 ↗
  • Oikonomidi T, Vikelis M, Artemiadis A, Chrousos GP, Darviri C. Reliability and Validity of the Greek Migraine Disability Assessment (MIDAS) Questionnaire. Pharmacoecon Open. 2018 Mar;2(1):77-85. doi: 10.1007/s41669-017-0034-3. PubMed 29464670 ↗
  • 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 ↗
  • Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available. PubMed 29368949 ↗
  • 9. Harmancı, H. and B. Kul, Pain catastrophizing in migraine patients and associated factors. Journal of Health Sciences and Medicine, 2017. 4(6): p. 876-881.
  • Shen B, Wu B, Abdullah TB, Zhan G, Lian Q, Vania Apkarian A, Huang L. Translation and validation of Simplified Chinese version of the Pain Catastrophizing Scale in chronic pain patients: Education may matter. Mol Pain. 2018 Jan-Dec;14:1744806918755283. doi: 10.1177/1744806918755283. Epub 2018 Jan 21. PubMed 29353539 ↗
  • Terkawi AS, Sullivan M, Abolkhair A, Al-Zhahrani T, Terkawi RS, Alasfar EM, Khait SSA, Elkabbani A, Kabbani N, Altirkawi KA, Tsang S. Development and validation of Arabic version of the pain catastrophizing scale. Saudi J Anaesth. 2017 May;11(Suppl 1):S63-S70. doi: 10.4103/sja.SJA_130_17. PubMed 28616005 ↗
  • Bond DS, Buse DC, Lipton RB, Thomas JG, Rathier L, Roth J, Pavlovic JM, Evans EW, Wing RR. Clinical Pain Catastrophizing in Women With Migraine and Obesity. Headache. 2015 Jul-Aug;55(7):923-33. doi: 10.1111/head.12597. Epub 2015 Jun 18. PubMed 26087348 ↗
  • Barral E, Buonanotte F. [Pain catastrophizing and medication overuse in patients with chronic migraine]. Rev Neurol. 2020 Apr 16;70(8):282-286. doi: 10.33588/rn.7008.2020034. Spanish. PubMed 32242334 ↗
  • Holroyd KA, Drew JB, Cottrell CK, Romanek KM, Heh V. Impaired functioning and quality of life in severe migraine: the role of catastrophizing and associated symptoms. Cephalalgia. 2007 Oct;27(10):1156-65. doi: 10.1111/j.1468-2982.2007.01420.x. Epub 2007 Sep 4. PubMed 17784854 ↗
  • Alvarez-Astorga A, Garcia-Azorin D, Hernandez M, de la Red H, Sotelo E, Uribe F, Guerrero AL. Pain catastrophising in a population of patients with migraine. Neurologia (Engl Ed). 2021 Jan-Feb;36(1):24-28. doi: 10.1016/j.nrl.2018.10.005. Epub 2019 Mar 8. English, Spanish. PubMed 30857787 ↗
  • Kim S, Bae DW, Park SG, Park JW. The impact of Pain-related emotions on migraine. Sci Rep. 2021 Jan 12;11(1):577. doi: 10.1038/s41598-020-80094-7. PubMed 33436778 ↗
  • Tol CHM, van der Meer HA, van der Wal AC, Su N, Visscher CM. Association between psychological factors and headache burden in patients with migraine and tension-type headache: a systematic review and meta-analysis. Disabil Rehabil. 2026 Aug;48(16):5117-5149. doi: 10.1080/09638288.2026.2621641. Epub 2026 Feb 16. PubMed 41693420 ↗

Individual participant data

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.

08

Registry details

Key details

Study ID
NCT07847528
Lead sponsor
National and Kapodistrian University of Athens
Responsible party
Michalis Kodounis (PhD, Neurologist, Medical Doctor, National and Kapodistrian University of Athens) — Principal investigator
First posted
Sep 29, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Michalis Kodounis, Neurologist, PhD
Contact
kodounis@gmail.com
+30 697 3600069
Dimos Mitsikostas, Neurologist, PhD
Contact
dimosmitsikostas@me.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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