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NCT Number: NCT07673926

Turkish Adaptation of the Pain and Smoking Inventory

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.

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Key information

Conditions

Chronic Pain Behavior Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Smoking

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bingol University Faculty of Physical Therapy and Rehabilitation, Bingoel, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Fagerström Test for Nicotine Dependence

    Time frame: at baseline

    A 6-item scale assessing the severity of nicotine dependence (scores range from 0 to 10; higher scores indicate higher dependence).

  2. Numerical Rating Scale

    Time frame: at baseline

    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).

  3. Pain Disability Index

    Time frame: at baseline

    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).

  4. Pain Self-Efficacy Questionnaire

    Time frame: at baseline

    A 10-item instrument assessing confidence in performing daily activities despite pain (scores range from 0 to 60; higher scores indicate higher self-efficacy).

  5. Hospital Anxiety and Depression Scale

    Time frame: at baseline

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Aybüke Fanuscu

CONTACT

[email protected]

+904262160012-5548

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Turkish Cultural Adaptation and Psychometric Properties of the Pain and Smoking Inventory in Individuals With Chronic Pain

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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