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Not yet recruitingNCT07847528Updated Oct 7, 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 2026-10-07.

Sponsored by National and Kapodistrian University of Athens · Observational

Updated Oct 7, 2026Start date movedNewly registeredGo to Updates ↓

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

Where this study stands

Counted across the records on this site · 2026-11-14

Among 13 studies in Migraine Disorders with a site in Greece — 3 open to participants now, 3 under way, none of them phase 3. Migraine Disorders · Greece.

Started
2026
with 2 others
Observational
6 of 13
3 open now
Registered
12th of 13
by date
Lead sponsor
5 of 13
National and Kapodistrian University of Athens

Among the 13 studies in Migraine Disorders with a site in Greece, this one is one of 3 that started in 2026, is one of 6 observational ones, and was the 12th registered.

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

Browse Migraine Disorders studies →

Open to participants now

3 of the 13 studies in Migraine Disorders with a site in Greece are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Greece have not opened yet or have stopped. Only those recruiting at a site in Greece →

Who these studies take

Of the 217 Migraine Disorders studies recruiting now, 66 (30%) set no upper age limit and 136 (63%) stop at 75 or younger; 44 take children under 18; 37 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Migraine Disorders with a site in Greece, or all of them as a file.
02

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.
03

Conditions studied

  • Migraine

Keywords

  • migraine
  • headache
  • pain catastrophizing
  • disability
  • quality of life
  • headache intensity
04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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)
05

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.

06

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

07

Study locations

1 site
08

References and documents

Publications

  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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.
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • Sullivan, M.J., S.R. Bishop, and J. Pivik, The pain catastrophizing scale: development and validation. Psychological assessment, 1995. 7(4): p. 524.
  • 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 ↗
  • Portney, L.G., Foundations of clinical research: applications to evidence-based practice. 2020: FA Davis.
  • 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 ↗

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.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.

Of 132 non-industry observational studies under Migraine Disorders, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 72. This study's planned 7 months is below that.

Counting every sponsor, half of 160 studies reached it within 27 months; a quarter within 13 and three quarters within 63.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Oct 7, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 22, 2026
First posted
Sep 29, 2026
StartEst.
Nov 1, 2026was Sep 2026
Primary completionEst.
Jun 1, 2027
CompletionEst.
Jul 1, 2027
Last update
Oct 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 1, 2026→Nov 1, 2026
Oct 7, 2026
Registered
First appeared on the registry
Sep 29, 2026
Show all 2 updates
  1. Oct 7, 2026
    Start date Sep 1, 2026→Nov 1, 2026
    + 2 other changes: verification date and references
  2. Sep 29, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07847528
Responsible party
Michalis Kodounis (PhD, Neurologist, Medical Doctor, National and Kapodistrian University of Athens) — Principal investigator
First posted
Sep 29, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Jun 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Oct 7, 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 ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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