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临床试验/NCT07673926
NCT07673926尚未招募不适用

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

Hacettepe University2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
2
主要终点
Turkish Pain and Smoking Inventory (PSI-TR)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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).

结局指标

主要结局

Turkish Pain and Smoking Inventory (PSI-TR)

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aybüke Fanuscu

assistant professor

Bingol University

研究点 (2)

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