Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07182968

Cultural Adaptation, Validity, and Reliability of the Turkish Version of The PASTUL Questionnaire

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Çankaya, Ankara, Turkey (Türkiye)

Location status: Recruiting

Location contact

Orkun Tüfekçi

CONTACT

[email protected]

05319502648

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals diagnosed with scleroderma,
  • Individuals aged 18 years and older

Exclusion criteria

  • Advanced heart/lung/liver/kidney disease, neurological disease, and malignancies
  • Individuals who are unwilling to participate

Treatment and study plan

Questionnaire study

Other

Questionnaire application

Primary outcomes

  1. Patient Self-Assessment of Skin Thickness in Upper Limb (PASTUL) Questionnaire

    Time frame: Two weeks

    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

  1. Scleroderma Health Assessment Questionnaire (SHAQ)

    Time frame: Two weeks

    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.

  2. Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ)

    Time frame: Two weeks

    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.

  3. Short Form-36 (SF-36)

    Time frame: Two weeks

    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.

  4. Modified Rodnan skin score (MRSS)

    Time frame: Two weeks

    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.

  5. Modified Hand Mobility in Scleroderma Test (mHAMIS)

    Time frame: Two weeks

    It is a functional test developed specifically for scleroderma to assess an individual's hand function. It evaluates four specific hand movements (finger flexion, finger extension, finger abduction, and dorsal extension). Scores range from 0 (normal) to 3 (complete failure) for each movement, with a total score ranging from 0 to 12.

  6. Scleroderma Skin Patient-Reported Outcomes (SSPRO) Questionnaire

    Time frame: Two weeks

    It assesses the impact of skin involvement on quality of life. The 18-item measure consists of 4 categories: physical effect (PE), emotional effect (EE), social effect (SE), and physical limitation (PL). Each item is scored on a scale ranging from no impairment (0 points) to severe impairment (6 points), with a total score of 108. A lower score indicates a much better quality of life.

  7. Cochin Hand Function Scale

    Time frame: Two weeks

    It consists of 18 questions related to daily activities. Each question is scored on a questionnaire of 0 (no difficulty) to 5 (impossible), and the total score ranges from 0 to 90. A total CHFS score of 26 or higher is considered to indicate hand function limitation.

Study contacts

Contact information is provided by the study sponsor or research team.

Orkun Tüfekçi, PT, PhD(c)

CONTACT

[email protected]

5319502648

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Cultural Adaptation, Validity, and Reliability of the Turkish Version of the Patient Assessment of Skin Thickness in the Upper Limb - PASTUL Questionnaire

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.