NCT07323849

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

December 17, 2025

Last Update Submit

March 30, 2026

Conditions

Keywords

Pelvic PainKinesiophobiaPain MeasurementQuestionnaires / PsychometricsPain

Outcome Measures

Primary Outcomes (1)

  • Kinesiophobia

    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).

    Baseline

Secondary Outcomes (2)

  • Fear-Avoidance Beliefs

    Baseline

  • Pain Catastrophizing

    Baseline

Study Arms (1)

Pelvic Pain

Adults aged 18 years or older with chronic pelvic pain who are able to read and understand Spanish and have provided informed consent. This cohort will complete self-administered questionnaires to assess fear of movement (TSK-PP) and related psychometric measures.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study participants will be selected from the adult population experiencing chronic pelvic pain. Eligible participants are adults aged 18 years or older who are able to read and understand Spanish and provide informed consent. The population includes individuals with varying demographic and clinical characteristics, such as age, sex, marital status, medical diagnosis, duration of pelvic pain, and pain severity. Participants will complete self-administered questionnaires at a single time point.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physiotherapy. University of Valencia

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Pelvic PainKinesiophobiaPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 17, 2025

First Posted

January 7, 2026

Study Start

December 15, 2025

Primary Completion

March 15, 2026

Study Completion

March 30, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations