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临床试验/NCT07323849
NCT07323849招募中不适用

Tampa Scale for Kinesiophobia for Pelvic Pain (TSK-PP). Adaptation, Translation, and Psychometric Validation.

University of Valencia1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
170
试验地点
1
主要终点
Kinesiophobia

研究概览

简要总结

The goal of this observational study is to adapt, translate, and evaluate the psychometric properties of the Tampa Scale for Kinesiophobia specifically for patients with pelvic pain (TSK-PP). The main questions it aims to answer are:

Can the TSK-PP reliably and validly measure fear of movement in individuals with pelvic pain?

Participants will complete standardized, self-administered questionnaires at a single point in time that assess:

Demographic and clinical characteristics (age, sex, marital status, medical diagnosis, duration and severity of pelvic pain) Fear of movement using the translated and adapted TSK-PP Fear-avoidance beliefs using the Fear-Avoidance Beliefs Questionnaire (FABQ) Pain catastrophizing using the Pain Catastrophizing Scale (PCS)

No interventions or treatments will be given as part of this study. The results will provide evidence on the reliability, validity, and clinical utility of the TSK-PP for use in research and practice with patients experiencing pelvic pain.

详细描述

Pelvic pain is a complex condition that can significantly impact daily functioning and quality of life. Fear of movement, or kinesiophobia, is recognized as a key psychological factor that may contribute to the transition from acute to chronic pain by promoting avoidance behaviors and limiting physical activity. Accurate measurement of kinesiophobia in patients with pelvic pain is essential for both clinical assessment and research purposes.

The Tampa Scale for Kinesiophobia (TSK) is a widely used instrument for assessing fear of movement, but its original items focus on general or musculoskeletal pain and do not capture the specific concerns of patients with pelvic pain. To address this gap, this study aims to adapt and translate the TSK for application in this population (TSK-PP) and evaluate its psychometric properties.

The study involves a rigorous process of cultural adaptation and translation, including item modification to reflect pelvic pain-specific contexts, forward translation into Spanish, independent review by an external expert, and back-translation into English to ensure conceptual equivalence. Following translation, the TSK-PP will be administered to adult patients with pelvic pain, alongside measures used for construct validation, including the Fear-Avoidance Beliefs Questionnaire (FABQ) and the Pain Catastrophizing Scale (PCS).

Data collected will include demographic and clinical characteristics such as age, sex, marital status, medical diagnosis, duration and severity of pelvic pain. These variables will allow for sample characterization and exploration of relationships with TSK-PP scores during psychometric evaluation.

This study will provide evidence on the reliability, validity, and applicability of the TSK-PP for assessing kinesiophobia in individuals with pelvic pain, supporting its use in both clinical practice and research settings.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • Age 18 years or older.
  • Presence of chronic pelvic pain.
  • Ability to read and understand Spanish.
  • Signed informed consent provided prior to participation.

排除标准

  • Inability to read or understand Spanish.
  • Refusal or failure to provide informed consent for participation in the study

结局指标

主要结局

Kinesiophobia

时间窗: Baseline

Fear of movement will be assessed using the Tampa Scale for Kinesiophobia adapted for patients with pelvic pain (TSK-PP), a translated and culturally adapted version of the original Tampa Scale for Kinesiophobia. The TSK-PP is a self-reported questionnaire consisting of 17 items, with total scores ranging from 17 to 68. Higher scores indicate greater levels of kinesiophobia (worse outcome).

次要结局

  • Fear-Avoidance Beliefs(Baseline)
  • Pain Catastrophizing(Baseline)

研究者

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

Borja Pérez-Domínguez

Associate Professor

University of Valencia

研究点 (1)

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