Chronic PainNCT07861698
Turkish Version of a Scale Measuring How People View Chronic Pain
An observational study of Chronic Pain, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- How many people
- 220 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2026to 15 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bilecik Eğitim ve Araştırma Hastanesi
Bilecik, 11000
Burcu Bayrak Kahraman, Assoc. Prof., +905057542411, burcu.bayrak@bilecik.edu.tr
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Chronic Pain
- Keywords
- Biopsychosocial Model of Pain, Cross-Cultural Adaptation, Turkish Adaptation, Validity, Reliability
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Construct validity and internal consistency of the Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale
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.
Measured: At the initial assessment (single administration)
Secondary outcomes (2)
Test-retest reliability of the Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale
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.
Measured: At the initial assessment and 2 weeks later
Criterion-related validity of the Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale
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
Measured: At the initial assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start15 Dec 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bilecik Seyh Edebali Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861698
- Sponsor's protocol ID
- PEB-TR-2026
- Status last verified
- Sep 2026
- First submitted
- 1 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Cross-Cultural Adaptation, Validity, and Reliability of the Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale
- ClinicalTrials.gov ID
- NCT07861698
- Acronym / sponsor ID
- PEB-TR-2026
- Conditions
- Chronic Pain
- Keywords
- Biopsychosocial Model of Pain, Cross-Cultural Adaptation, Turkish Adaptation, Validity, Reliability
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Bilecik Seyh Edebali UniversitesiUniversity, hospital or other
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Construct validity and internal consistency of the Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale
Time frame: At the initial assessment (single administration)
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.
2 secondary outcomes
Test-retest reliability of the Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale
Time frame: At the initial assessment and 2 weeks later
Criterion-related validity of the Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale
Time frame: At the initial assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Burcu Bayrak Kahraman, PhD (+905057542411, burcu.bayrak@bilecik.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Construct validity and internal consistency of the Patients' Endorsement of a Biopsychosocial Model of Chronic Pain Scale (time frame: At the initial assessment (single administration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.