- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07861698
Turkish Version of a Scale Measuring How People View Chronic Pain
Turkish Cross-Cultural Adaptation, Validity, and Reliability of the Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale
This study will translate and culturally adapt the Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale (PEB) into Turkish and evaluate how well and consistently it measures the views of adults with chronic pain. The study will take place at the Physical Medicine and Rehabilitation outpatient clinic of Bilecik Training and Research Hospital. At least 200 adults will be included in the main sample. Participants will complete questionnaires that are expected to take 10 to 15 minutes. An additional 20 people who will not be included in the main sample will take part in a pilot assessment. Fifty participants from the main sample will complete the PEB Scale again after two weeks. No treatment or intervention will be assigned.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
This is a methodological, cross-sectional study with a prospective test-retest component. The Turkish cross-cultural adaptation will include independent forward translations, reconciliation of the translations, independent back-translations, comparison with the original scale, and review of discrepancies. Seven experts in relevant fields will assess the clarity, cultural suitability, and content relevance of the items. The revised form will be pilot-tested with 20 adults with chronic pain who will not be included in the main sample.
The main psychometric evaluation will include at least 200 adults with chronic pain. Exploratory and confirmatory factor analyses will be used to evaluate the scale structure. Criterion-related validity will be assessed through correlations with pain beliefs, pain-related self-efficacy, pain intensity, interference with daily activities, and pain-related distress. Internal consistency and item characteristics will also be examined. Measurement invariance across selected participant groups will be evaluated using multigroup confirmatory factor analysis.
For test-retest reliability, 50 participants from the main sample whose clinical condition is not expected to change substantially will complete the PEB Scale again after two weeks. Agreement between the two measurements will be assessed using the intraclass correlation coefficient and its 95% confidence interval.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Burcu Bayrak Kahraman, PhD
- Telefonnummer: +905057542411
- E-Mail: burcu.bayrak@bilecik.edu.tr
Studienorte
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Bilecik, Türkei (türkiye), 11000
- Bilecik Eğitim ve Araştırma Hastanesi
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Kontakt:
- Burcu Bayrak Kahraman, Assoc. Prof.
- Telefonnummer: +905057542411
- E-Mail: burcu.bayrak@bilecik.edu.tr
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Adults aged 18 years or older with physician-diagnosed chronic pain lasting or recurring for more than 3 months who receive follow-up or treatment at the Physical Medicine and Rehabilitation outpatient clinic of Bilecik Training and Research Hospital, Türkiye.
Beschreibung
Inclusion Criteria:
- Aged 18 years or older.
- Voluntarily agrees to participate in the study.
- Has physician-diagnosed chronic pain lasting or recurring for more than 3 months.
- Able to read and write Turkish.
- Has sufficient cognitive ability to understand and complete the data collection forms.
Exclusion Criteria:
- Presents with acute pain or does not meet the chronic pain criteria.
- Has a cognitive or communication impairment that prevents completion of the data collection forms.
- Submits incomplete data collection forms.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: OTHER
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
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Adults With Chronic Pain
Adults aged 18 years or older with physician-diagnosed chronic pain lasting or recurring for more than 3 months. At least 200 participants will be included in the main sample, and an additional 20 participants will take part in the pilot assessment. Fifty participants from the main sample will complete the PEB Scale again after two weeks. No intervention will be assigned. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Construct validity and internal consistency of the Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale
Zeitfenster: At the initial assessment (single administration)
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The Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale (PEB Scale) consists of 11 items rated on a 4-point scale (1-4), yielding a total score of 11-44. Higher scores indicate stronger endorsement of the biopsychosocial model of chronic pain and represent a more favorable outcome. Construct validity will be evaluated using exploratory and confirmatory factor analyses. Internal consistency will be assessed using Cronbach's alpha and corrected item-total correlations. |
At the initial assessment (single administration)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Test-retest reliability of the Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale
Zeitfenster: At the initial assessment and 2 weeks later
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The Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale (PEB Scale) consists of 11 items rated on a 4-point scale (1-4), yielding a total score of 11-44. Higher scores indicate stronger endorsement of the biopsychosocial model of chronic pain and represent a more favorable outcome. A subsample of 50 participants will complete the scale again after 2 weeks. Test-retest reliability will be evaluated using the intraclass correlation coefficient (ICC) and its 95% confidence interval. |
At the initial assessment and 2 weeks later
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Criterion-related validity of the Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale
Zeitfenster: At the initial assessment
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Criterion-related validity will be assessed by examining correlations between scores on the Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale (PEB Scale), the Pain Beliefs Questionnaire, the University of Washington Pain-Related Self-Efficacy Scale Short Form, and three 0-10 Numeric Rating Scale (NRS) items. The PEB Scale has 11 items rated 1-4, with a total score of 11-44; higher scores indicate stronger endorsement of the biopsychosocial model and represent a more favorable outcome. The Pain Beliefs Questionnaire has Organic Beliefs and Psychological Beliefs subscale mean scores ranging from 1-6; higher scores indicate stronger beliefs in the corresponding domain, with no uniformly better or worse direction. The University of Washington Pain-Related Self-Efficacy Scale Short Form has 6 items rated 1-5, with a total score of 6-30; higher scores indicate greater pain-related self-efficacy and represent a more favorable outcome. The three NRS items assess pain int |
At the initial assessment
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PEB-TR-2026
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
No individual participant data will be shared with other researchers. The study involves sensitive health information, and participant confidentiality will be protected. Study findings will be reported in aggregate.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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