ClinicalTrials.gg
RecruitingNCT07182968Updated Sep 19, 2025

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

An observational study in Systemic Sclerosis (SSc), Systemic Sclerosis (Scleroderma) and Scleroderma (Limited and Diffuse), sponsored by Hacettepe University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Hacettepe University · Observational

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Systemic Sclerosis (SSc)
  • Systemic Sclerosis (Scleroderma)
  • Scleroderma (Limited and Diffuse)
  • Patient Perspective
03

In context

Scleroderma, Systemic

610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.

This study's planned enrollment of 50 is below the median of 100 across 145 observational studies indexed under Scleroderma, Systemic.

Browse Scleroderma, Systemic studies →

Lead sponsor

Hacettepe University is the lead sponsor of 1,007 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study population will consist of individuals who come to the university hospital for routine controls.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Advanced heart/lung/liver/kidney disease, neurological disease, and
  • Individuals who are unwilling to participate
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
2 Weeks
Patient registry
Yes

Groups and cohorts

  • Systemic sclerosis

    Other: Questionnaire study

Interventions

  • OtherQuestionnaire study

    Questionnaire application

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Two weeks

Secondary outcomes

  1. 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.

    Time frame: Two weeks

  2. 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.

    Time frame: Two weeks

  3. 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.

    Time frame: Two weeks

  4. 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.

    Time frame: Two weeks

  5. 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.

    Time frame: Two weeks

  6. 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.

    Time frame: Two weeks

  7. 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.

    Time frame: Two weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07182968
Responsible party
Orkun Tüfekçi (Principal Investigator, PT, PhD(c), Hacettepe University) — Principal investigator
First posted
Sep 19, 2025
Start date
Aug 4, 2025
Primary completion
Aug 2027 (estimated)
Completion
Aug 4, 2027 (estimated)
Last update
Sep 19, 2025

Study contacts

Orkun Tüfekçi, PT, PhD(c)
Contact
orkuntf@gmail.com
5319502648

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion