Chronic PainNCT07673926
Turkish Adaptation of the Pain and Smoking Inventory
An observational study of Chronic Pain, run by Hacettepe University at 2 sites in Turkey (Türkiye).
Trial summary
The purpose of this study is to perform the Turkish cross-cultural adaptation of the Pain and Smoking Inventory (PSI) and to comprehensively evaluate its reliability, validity, and psychometric properties among daily cigarette smokers with chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain
- How many people
- 200 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Sep 2026to 30 Jun 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18 and older who present to the outpatient clinic with chronic musculoskeletal or systemic pain and are also daily cigarette smokers. The sample will be selected from individuals who are being followed up or treated at a state hospital. It includes individuals from various sociodemographic backgrounds who meet the specific pain duration and smoking quantity criteria, representing a clinical sample of smoking chronic pain patients in Turkey.
Who may be able to join
- Aged 18 years and older.
- Having a diagnosis of chronic pain that has persisted for at least 3 months.
- Smoking at least 5 cigarettes per day (within the last 30 days).
- Being able to read and write in Turkish.
- Volunteering to participate in the study and signing the written informed consent form.
Who cannot join
- Having a diagnosis of active psychosis or severe depression.
- Having a diagnosis of cognitive impairment or intellectual disability.
- Having severe alcohol dependence or substance use disorder.
- Having reading and writing difficulties to a degree that prevents completing the questionnaire independently.
- Being in the pregnancy or breastfeeding period.
- Using nicotine replacement therapy or smoking cessation medication within the last 1 month.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Bingol University Faculty of Physical Therapy and Rehabilitation
Bingoel
Aybüke Fanuscu, +904262160012-5548, afanuscu@bingol.edu.tr
- Recruiting
Bingöl State Hospital
Bingoel
Mehmet Gök, MD, +904262142217, mgok19866@gmail.com
About this study
Official title: Turkish Cultural Adaptation and Psychometric Properties of the Pain and Smoking Inventory in Individuals With Chronic Pain
The purpose of this study is to perform the Turkish cross-cultural adaptation of the Pain and Smoking Inventory (PSI) and to comprehensively evaluate its reliability, validity, and psychometric properties among daily cigarette smokers with chronic pain.
Read the detailed description
This methodological and cross-sectional study consists of two primary phases: (1) the cross-cultural adaptation of the Pain and Smoking Inventory (PSI) into Turkish, and (2) the evaluation of the psychometric properties, reliability, and validity of the Turkish version (PSI-TR). The study will be conducted at the Bingöl University Faculty of Physical Therapy and Rehabilitation and the Bingöl State Hospital Physical Medicine and Rehabilitation Outpatient Clinic. Data collection will be carried out using printed forms and an online survey platform (Kobotoolbox).
Translation and Cultural Adaptation Process
The cultural adaptation process of the PSI will be performed in accordance with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines. The process involves five distinct stages:
Forward translation from English to Turkish by two independent translators. A reconciliation meeting to merge the translations into a single synthesis version.
Backward translation of the synthesized version into English by two independent translators who are blind to the original scale.
Review of the backward translation by the original scale developer. A pilot test with 10 individuals to assess semantic clarity and comprehensibility before finalization.
- Conditions
- Chronic Pain
- Keywords
- chronic pain, smoking, Cross-Cultural Adaptation
- Medical subject headings
- Chronic Pain, Smoking
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 |
|---|---|---|
| Smokers with Chronic Pain | Adult individuals aged 18 and older who have been experiencing chronic pain for at least 3 months and smoke at least 5 cigarettes per day (within the last 30 days). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turkish Pain and Smoking Inventory (PSI-TR)
The Pain and Smoking Inventory (PSI) is a 9-item self-report scale designed to assess the perceived interrelations between chronic pain and tobacco smoking. It measures three conceptual domains: pain as a motivator for smoking, smoking as a coping strategy for pain, and pain as a barrier to smoking cessation. Each item is scored on a 7-point Likert-type scale ranging from 0 to 6. The total score ranges from 0 to 54, where higher scores indicate a stronger perceived relationship between pain and smoking behaviors.
Measured: at baseline
Secondary outcomes (5)
Fagerström Test for Nicotine Dependence
A 6-item scale assessing the severity of nicotine dependence (scores range from 0 to 10; higher scores indicate higher dependence).
Measured: at baseline
Numerical Rating Scale
An 11-point scale assessing average pain intensity over the last week (scores range from 0 to 10; 0 = no pain, 10 = worst possible pain).
Measured: at baseline
Pain Disability Index
A 7-item questionnaire measuring the impact of chronic pain on daily life activities across seven domains (scores range from 0 to 70; higher scores indicate greater disability).
Measured: at baseline
Pain Self-Efficacy Questionnaire
A 10-item instrument assessing confidence in performing daily activities despite pain (scores range from 0 to 60; higher scores indicate higher self-efficacy).
Measured: at baseline
Hospital Anxiety and Depression Scale
A 14-item scale with two subscales evaluating anxiety (7 items) and depression (7 items) symptom severity (scores for each subscale range from 0 to 21; higher scores indicate greater distress).
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start15 Sep 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aybüke Fanuscu, Bingol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673926
- Sponsor's protocol ID
- AF-202602
- Status last verified
- Oct 2026
- First submitted
- 23 Jun 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To ensure participant privacy and data confidentiality in accordance with national data protection laws (KVKK) and the approved ethical committee protocol, individual participant data will not be shared with third parties.
Publications
Yamada K, Kimura T, Mizunuma N, Tabuchi T. Pain-Related Smoking Expectancies Across Tobacco Product Use Patterns, Including Heated Tobacco Products: Psychometric Validation of the Japanese Pain and Smoking Inventory. Neuropsychopharmacol Rep. 2026 Jun;46(2):e70119. doi: 10.1002/npr2.70119.
PubMed 41963748Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.
PubMed 15804318Ditre JW, Zale EL, Heckman BW, Hendricks PS. A measure of perceived pain and tobacco smoking interrelations: pilot validation of the pain and smoking inventory. Cogn Behav Ther. 2017 Jun;46(4):339-351. doi: 10.1080/16506073.2016.1256347. Epub 2016 Nov 22.
PubMed 27871214
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Cultural Adaptation and Psychometric Properties of the Pain and Smoking Inventory in Individuals With Chronic Pain
- ClinicalTrials.gov ID
- NCT07673926
- Acronym / sponsor ID
- AF-202602
- Conditions
- Chronic Pain
- Keywords
- chronic pain, smoking, Cross-Cultural Adaptation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Jun 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.
The purpose of this study is to perform the Turkish cross-cultural adaptation of the Pain and Smoking Inventory (PSI) and to comprehensively evaluate its reliability, validity, and psychometric properties among daily cigarette smokers with chronic pain.
Detailed description
This methodological and cross-sectional study consists of two primary phases: (1) the cross-cultural adaptation of the Pain and Smoking Inventory (PSI) into Turkish, and (2) the evaluation of the psychometric properties, reliability, and validity of the Turkish version (PSI-TR). The study will be conducted at the Bingöl University Faculty of Physical Therapy and Rehabilitation and the Bingöl State Hospital Physical Medicine and Rehabilitation Outpatient Clinic. Data collection will be carried out using printed forms and an online survey platform (Kobotoolbox).
Translation and Cultural Adaptation Process
The cultural adaptation process of the PSI will be performed in accordance with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) guidelines. The process involves five distinct stages:
Forward translation from English to Turkish by two independent translators. A reconciliation meeting to merge the translations into a single synthesis version.
Backward translation of the synthesized version into English by two independent translators who are blind to the original scale.
Review of the backward translation by the original scale developer. A pilot test with 10 individuals to assess semantic clarity and comprehensibility before finalization.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smokers with Chronic Pain | – | –Adult individuals aged 18 and older who have been experiencing chronic pain for at least 3 months and smoke at least 5 cigarettes per day (within the last 30 days). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 and older who present to the outpatient clinic with chronic musculoskeletal or systemic pain and are also daily cigarette smokers. The sample will be selected from individuals who are being followed up or treated at a state hospital. It includes individuals from various sociodemographic backgrounds who meet the specific pain duration and smoking quantity criteria, representing a clinical sample of smoking chronic pain patients in Turkey.
Key inclusion criteria (5 listed)
- Aged 18 years and older.
- Having a diagnosis of chronic pain that has persisted for at least 3 months.
- Smoking at least 5 cigarettes per day (within the last 30 days).
- Being able to read and write in Turkish.
- Volunteering to participate in the study and signing the written informed consent form.
Key exclusion criteria (6 listed)
- Having a diagnosis of active psychosis or severe depression.
- Having a diagnosis of cognitive impairment or intellectual disability.
- Having severe alcohol dependence or substance use disorder.
- Having reading and writing difficulties to a degree that prevents completing the questionnaire independently.
- Being in the pregnancy or breastfeeding period.
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
Turkish Pain and Smoking Inventory (PSI-TR)
Time frame: at baseline
The Pain and Smoking Inventory (PSI) is a 9-item self-report scale designed to assess the perceived interrelations between chronic pain and tobacco smoking. It measures three conceptual domains: pain as a motivator for smoking, smoking as a coping strategy for pain, and pain as a barrier to smoking cessation. Each item is scored on a 7-point Likert-type scale ranging from 0 to 6. The total score ranges from 0 to 54, where higher scores indicate a stronger perceived relationship between pain and smoking behaviors.
5 secondary outcomes
Fagerström Test for Nicotine Dependence
Time frame: at baseline
Numerical Rating Scale
Time frame: at baseline
Pain Disability Index
Time frame: at baseline
Pain Self-Efficacy Questionnaire
Time frame: at baseline
Hospital Anxiety and Depression Scale
Time frame: at baseline
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 2 Nov 2026.
- Background: PubMed 41963748Yamada K, Kimura T, Mizunuma N, Tabuchi T. Pain-Related Smoking Expectancies Across Tobacco Product Use Patterns, Including Heated Tobacco Products: Psychometric Validation of the Japanese Pain and Smoking Inventory. Neuropsychopharmacol Rep. 2026 Jun;46(2):e70119. doi: 10.1002/npr2.70119.
- Background: PubMed 15804318Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.
- Background: PubMed 27871214Ditre JW, Zale EL, Heckman BW, Hendricks PS. A measure of perceived pain and tobacco smoking interrelations: pilot validation of the pain and smoking inventory. Cogn Behav Ther. 2017 Jun;46(4):339-351. doi: 10.1080/16506073.2016.1256347. Epub 2016 Nov 22.
- Individual participant dataSharing planned: No. To ensure participant privacy and data confidentiality in accordance with national data protection laws (KVKK) and the approved ethical committee protocol, individual participant data will not be shared with third parties.
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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.
2 sites 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 Hacettepe University at 2 sites 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 6 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Aybüke Fanuscu (+904262160012-5548, afanuscu@bingol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turkish Pain and Smoking Inventory (PSI-TR) (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07673926, which also lists 3 linked publications.
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 2 Nov 2026.