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Набор скоро начнётся NCT07673926

Turkish Adaptation of the Pain and Smoking Inventory

— Наблюдательное Chronic Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Chronic Pain. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Turkish Pain and Smoking Inventory (PSI-TR) [Срок оценки: at baseline]
Вторичные конечные точки (5)
  • Fagerström Test for Nicotine Dependence [Срок оценки: at baseline]
  • Numerical Rating Scale [Срок оценки: at baseline]
  • Pain Disability Index [Срок оценки: at baseline]
  • Pain Self-Efficacy Questionnaire [Срок оценки: at baseline]
  • Hospital Anxiety and Depression Scale [Срок оценки: at baseline]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Turkey (Türkiye) · 2 центра
  • Bingol University Faculty of Physical Therapy and Rehabilitation — Bingoel
  • Bingöl State Hospital — Bingoel

Публикации

  • 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 41963748
  • 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.1524-4733.2 PMID 15804318
  • 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 27871214

Идентификаторы

NCT: NCT07673926 · AF-202602

Первоисточники (государственные реестры)

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