NCT07673926

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

June 23, 2026

Last Update Submit

June 23, 2026

Conditions

Keywords

chronic painsmokingCross-Cultural Adaptation

Outcome Measures

Primary Outcomes (1)

  • 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.

    at baseline

Secondary Outcomes (5)

  • Fagerström Test for Nicotine Dependence

    at baseline

  • Numerical Rating Scale

    at baseline

  • Pain Disability Index

    at baseline

  • Pain Self-Efficacy Questionnaire

    at baseline

  • Hospital Anxiety and Depression Scale

    at baseline

Study Arms (1)

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).

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bingol University Faculty of Physical Therapy and Rehabilitation

Bingoel, Turkey (Türkiye)

Location

Bingöl State Hospital

Bingoel, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 41963748BACKGROUND
  • Wild 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.

    PMID: 15804318BACKGROUND
  • Ditre 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.

    PMID: 27871214BACKGROUND

MeSH Terms

Conditions

Chronic PainSmoking

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

June 23, 2026

First Posted

June 29, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

June 29, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations