About this trial
The Patient Self-Assessment of Skin Thickness in Upper Limb (PASTUL) questionnaire was developed to enable patients to assess skin thickness in systemic sclerosis (SSc) physically and has been validated for reliability and validity, as it correlates with the modified Rodnan Skin Score (mRSS), which rheumatologists assess. Thus, it has been demonstrated to be an applicable and easy approach for assessing skin thickness in SSc patients through patient-reported measurements. This study aimed to develop a Turkish version of the PASTUL questionnaire and to provide for its use in the Turkish population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals diagnosed with scleroderma,
Individuals aged 18 years and older
Disqualifiers
Advanced heart/lung/liver/kidney disease, neurological disease, and malignancies
Individuals who are unwilling to participate
Trial population
The study population will consist of individuals who come to the university hospital for routine controls.
Trial design
Cohort
Prospective
Treatments tested in this trial
Questionnaire study
Other interventionQuestionnaire application
Treatment groups
Trial outcomes
Primary outcomes
Patient Self-Assessment of Skin Thickness in Upper Limb (PASTUL) Questionnaire
The PASTUL survey is a simple assessment by the patient of the skin in eight areas of the upper extremities as normal, mildly, moderately, or severely thickened, corresponding to the mRSS assessment. The assessment score is consistent with the mRSS (0-3). A high score indicates increased skin thickness
Secondary outcomes
Scleroderma Health Assessment Questionnaire (SHAQ)
It was developed by adding five questions to the HAQ regarding Raynaud's phenomenon, digital ulcers, gastrointestinal, pulmonary, and general scleroderma symptoms, to be rated on a 15 cm line. The SHAQ total score ranges from 0 to 3. A high score indicates low functionality.
Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ)
It was standardized as a biopsychosocial assessment tool and is scored using a 5-point Likert scale, with each item rated from 0 to 4 points. A high total score on the 30-item scale indicates a high level of biopsychosocial impact.
Short Form-36 (SF-36)
It will be used to determine an individual's quality of life levels. Each sub-parameter is scored between 0 and 100 points, with a high score indicating good health status. The SF-36 scale has eight sub-parameters: general health perception, physical function, social function, pain, mental health, role difficulty due to physical reasons, role difficulty due to emotional reasons, and vitality. It contains 11 questions consisting of a total of 36 items.
Modified Rodnan skin score (MRSS)
A pediatric and adult rheumatologist assessed it. The MRSS evaluates skin thickening in 17 body regions, graded from 0 (normal) to 3 (severe skin thickening). The total score ranges from 0 to 51, with increased scores indicating poor skin involvement.
Sponsors and contacts
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