- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04644263
Turkish Validity and Reliability of The Tampa Scale for Kinesiophobia for Temporomandibular Disorders
Objective: The aim of this study is to evaluate the validity and reliability of the Turkish version of the 'The Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD)' questionnaire used to assess kinesiophobia in temporomandibular joint disorders.
Method: The "Tampa Kinesiophobia Scale in Temporomandibular Disorders" (TSK-TMD), which consists of 12 item, was adapted to Turkish with the translation and back-translation method. 111 patients (75 females, 36 males) who had been diagnosed with temporomandibular joint for at least 6 months and diagnosed as Temporomandibular Joint Disorder were participated to fill out the questionnaire. In the present study, participants were assessed with the Temporomandibular joint disorders evaluation form, Turkish TSK-TMD-12 item, Visuel Analogue Scale (VAS) and Pain Catastrophizing Scale (PCS). The internal consistency and test-retest reliability with a 3-5 days time were used to evaluate the reliability of the TSK-TMD. The reliability of the corelatıon was checked with PCS. Construct validity was assessed based on confirmatory factor analysis (CFA).
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Pre-test: 10 patients temporomandibular disorders evaluated. Inclusion and exlusion criteria listed above.
Validation and reliability: 111 patients with temporomandibular disorders evaluated.Inclusion and exlusion criteria listed above.
Description
Inclusion Criteria::
- volunteer participation in the study, between 18 and 65 years old,
- having symptoms for at least 6 months,
- being literate, and having communication to understand and answer questions.
Exclusion Criteria:
- toothache
- Cognitive impairment affecting their ability to understand and complete the study questionnaire
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Validity and reliability
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The Tampa Scale for Kinesiophobia for Temporomandibular Disorders
Time Frame: The measurement is one-time and take 20 minutes. It take an average of 6 month after the data of all participants are collected.
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The original TSK-TMD is an English scale and consists of 18 items to evaluate the fear of movement in TMD patients.
4-point Likert type scoring is used (1-strongly disagree, 2-partially disagree, 3-partially agree and 4- strongly agree).
Total score is calculated by reversing 4, 8, 12, 16 items.
In this short form, by collecting all points, scores between 12-48 are obtained.
The higher the person's score indicates, the higher the kinesiophobia.
They suggested that the 12-item version had good reliability and validity as a result of the structural reliability assessment and was more suitable for evaluation in TMD patients.
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The measurement is one-time and take 20 minutes. It take an average of 6 month after the data of all participants are collected.
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Pain Catastrophizing Scala
Time Frame: The measurement is one-time and take 15 minutes. It take an average of 6 month after the data of all participants are collected.
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It is a scale developed to detect catastrophic thoughts or feelings and ineffective coping methods of pain experienced by patients in the past.
It describes the different thoughts and feelings that individuals can experience while suffering.
PCS is a scale consisting of thirteen items and three factors such as helplessness, enlargement and self-reflection.
Likert type scoring is evaluated between 0-4 points.
The total score ranges from 0-52.
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The measurement is one-time and take 15 minutes. It take an average of 6 month after the data of all participants are collected.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Eylem Kucuk, OkanU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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