Systemic Sclerosis (SSc)NCT07182968
Cultural Adaptation, Validity, and Reliability of the Turkish Version of The PASTUL Questionnaire
An observational study of Systemic Sclerosis (SSc) and Systemic Sclerosis (Scleroderma), run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis (SSc), Systemic Sclerosis (Scleroderma), Scleroderma (Limited and Diffuse)
- What is being tested?
- Questionnaire study
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Aug 2025to 4 Aug 2027
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of individuals who come to the university hospital for routine controls.
Who may be able to join
- Individuals diagnosed with scleroderma,
- Individuals aged 18 years and older
Who cannot join
- Advanced heart/lung/liver/kidney disease, neurological disease, and malignancies
- Individuals who are unwilling to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Çankaya, Ankara
Orkun Tüfekçi, 05319502648, orkuntf@gmail.com
About this study
Official title: Cultural Adaptation, Validity, and Reliability of the Turkish Version of the Patient Assessment of Skin Thickness in the Upper Limb - 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.
- Conditions
- Systemic Sclerosis (SSc), Systemic Sclerosis (Scleroderma), Scleroderma (Limited and Diffuse), Patient Perspective
- Being tested
- Questionnaire study
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire studyOther
Questionnaire application
| Study group | Role | What they receive |
|---|---|---|
| Systemic sclerosis | Not described Receives: Other: Questionnaire study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Two weeks
Secondary outcomes (7)
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.
Measured: Two weeks
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.
Measured: Two weeks
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.
Measured: Two weeks
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.
Measured: Two weeks
Modified Hand Mobility in Scleroderma Test (mHAMIS)
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.
Measured: Two weeks
Scleroderma Skin Patient-Reported Outcomes (SSPRO) Questionnaire
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.
Measured: Two weeks
Cochin Hand Function Scale
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.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start4 Aug 2025
- Primary completionAug 2027 (estimated)
- Study completion4 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Sclerosis (SSc)Studies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orkun Tüfekçi, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182968
- Sponsor's protocol ID
- SBA 24/531
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Adaptation, Validity, and Reliability of the Turkish Version of the Patient Assessment of Skin Thickness in the Upper Limb - PASTUL Questionnaire
- ClinicalTrials.gov ID
- NCT07182968
- Acronym / sponsor ID
- SBA 24/531
- Conditions
- Systemic Sclerosis (SSc), Systemic Sclerosis (Scleroderma), Scleroderma (Limited and Diffuse), Patient Perspective
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- 4 Aug 2027 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systemic sclerosis | – | Other: Questionnaire study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of individuals who come to the university hospital for routine controls.
Key inclusion criteria (2 listed)
- Individuals diagnosed with scleroderma,
- Individuals aged 18 years and older
Key exclusion criteria (2 listed)
- Advanced heart/lung/liver/kidney disease, neurological disease, and malignancies
- Individuals who are unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire studyQuestionnaire application | Other | Systemic sclerosis |
Primary outcome
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
7 secondary outcomes
Scleroderma Health Assessment Questionnaire (SHAQ)
Time frame: Two weeks
Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ)
Time frame: Two weeks
Short Form-36 (SF-36)
Time frame: Two weeks
Modified Rodnan skin score (MRSS)
Time frame: Two weeks
Modified Hand Mobility in Scleroderma Test (mHAMIS)
Time frame: Two weeks
Scleroderma Skin Patient-Reported Outcomes (SSPRO) Questionnaire
Time frame: Two weeks
Cochin Hand Function Scale
Time frame: Two weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis (SSc) and Systemic Sclerosis (Scleroderma), run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Orkun Tüfekçi, PT, PhD(c) (5319502648, orkuntf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Self-Assessment of Skin Thickness in Upper Limb (PASTUL) Questionnaire (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.