Clinical Trials Directory

Trials / Completed

CompletedNCT07323849

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
170 (actual)
Sponsor
University of Valencia · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Timeline

Start date
2025-12-15
Primary completion
2026-03-15
Completion
2026-03-30
First posted
2026-01-07
Last updated
2026-03-31

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT07323849. Inclusion in this directory is not an endorsement.