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Turkish Adaptation of the Pain and Smoking Inventory

H

Hacettepe University

Status

Not yet enrolling

Conditions

Chronic Pain

Study type

Observational

Funder types

Other

Identifiers

NCT07673926
AF-202602

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 design

200 participants in 1 patient group

Smokers with Chronic Pain
Description:
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).

Trial contacts and locations

2

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Central trial contact

Aybüke Fanuscu

Data sourced from clinicaltrials.gov

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