CClinicalTrials.gg
Status unknownNCT04858464Updated Sep 8, 2021

Reliability, Validity of the Turkish Version of the Primary Sjögren Syndrome Quality of Life (PSS-QoL) Questionnaire

An observational study in Primary Sjögren's Syndrome, sponsored by Gazi University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-09-08.

Sponsored by Gazi University · Observational

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
75
Ages
18 Years to 90 Years
Sex
All
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Study summary

The purpose of this study was to investigate adaptation, validity, and reliability of the Turkish version of the Primary Sjögren's Syndrome Quality of Life (PSS-QoL) Questionnaire

Read the detailed description

Primary Sjögren's Syndrome (PSS) is a chronic systemic disease characterized by lymphocytic infiltration of exocrine glands. Dryness, chronic pain, physical fatigue, glandular and extraglandular symptoms seen in PSS cause deterioration of the health-related quality of life.

The Primary Sjögren's Syndrome Quality of Life (PSS-QoL) Questionnaire has recently developed as a patient-reported condition-specific outcome measurement tool to assess the quality of life associated with PSS. The PSS-QoL questionnaire consists of 25 questions with a physical and psychosocial dimension.The physical dimension consists of a numeric rating scale (NRS, ranging from 0 to 10) for pain and physical symptoms. The question related to vaginal dryness is intended to be answered by women only. Each "yes" answer about physical symptoms-related questions adds 1 point to the score. The psychosocial dimension can be scored on a 5-point Likert scale and contains 14 question with the following possible answers: never (0), rarely (1), sometimes (2), often (3), and always (4). The PSS-QoL score ranges from 0-96 (for women) and 0-92 (excluding the question of vaginal dryness for men). After questioning the sociodemographic characteristics of the individuals, PSS-QoL, EuroQuol-5D, the EULAR Sjögren's Syndrome Disease Activity Index and EULAR Sjögren's Syndrome Patient Reported Index will be used. Test-retest will be re-applied to those of the same individuals who can be reached after 1 week. The results will be analyzed using the SPSS version 22.0 computer package program.

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Conditions studied

  • Primary Sjögren's Syndrome

Keywords

  • Primary Sjögren's Syndrome
  • Quality of Life
  • Patient-reported Outcome
  • Reliability
  • Validity
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In context

Sjogren's Syndrome

371 studies on the registry are indexed under Sjogren's Syndrome; 104 are open to participants now.

This study's planned enrollment of 75 is below the median of 114 across 113 observational studies indexed under Sjogren's Syndrome.

Browse Sjogren's Syndrome studies →

Lead sponsor

Gazi University is the lead sponsor of 531 studies on the registry; 99 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients with primary Sjögren's syndrome between the ages of 18-90

Inclusion criteria

  • Diagnosed with primary Sjögren's syndrome

Exclusion criteria

Exclusion Criteria:

  • Having neurological and cognitive disorders,
  • Having another rheumatological diseases
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
75 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients group

    Individuals with primary Sjögren's syndrome

    Other: Survey study

Interventions

  • OtherSurvey study

    Patients will complete the mentioned questionnaires.

    Also known as: Questionnaire application

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What researchers measure

Primary outcomes

  1. Primary Sjögren's Syndrome Quality of Life (PSS-QoL) Questionnaire

    Primary Sjögren's Syndrome Quality of Life (PSS-QoL) Questionnaire was designed to evaluate measurement of health related quality of life in patients with primary Sjögren's syndrome.

    Time frame: 10 minutes

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Study locations

1 of 1 sites recruiting
  • Gazi University
    Ankara, Turkey
    • Selin Bayram, Msc · Contact
    Recruiting
08

References and documents

Publications

  • Lackner A, Stradner MH, Hermann J, Unger J, Stamm T, Graninger WB, Dejaco C. Assessing health-related quality of life in primary Sjogren's syndrome-The PSS-QoL. Semin Arthritis Rheum. 2018 Aug;48(1):105-110. doi: 10.1016/j.semarthrit.2017.11.007. Epub 2017 Nov 27. PubMed 29395257 ↗
  • Ng WF, Bowman SJ. Primary Sjogren's syndrome: too dry and too tired. Rheumatology (Oxford). 2010 May;49(5):844-53. doi: 10.1093/rheumatology/keq009. Epub 2010 Feb 10. PubMed 20147445 ↗
  • Lackner A, Ficjan A, Stradner MH, Hermann J, Unger J, Stamm T, Stummvoll G, Dur M, Graninger WB, Dejaco C. It's more than dryness and fatigue: The patient perspective on health-related quality of life in Primary Sjogren's Syndrome - A qualitative study. PLoS One. 2017 Feb 9;12(2):e0172056. doi: 10.1371/journal.pone.0172056. eCollection 2017. PubMed 28182787 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04858464
Lead sponsor
Gazi University
Responsible party
Selin Bayram (Msc, Gazi University) — Principal investigator
First posted
Apr 26, 2021
Start date
May 2, 2021
Primary completion
May 2, 2023 (estimated)
Completion
May 2, 2023 (estimated)
Last update
Sep 8, 2021

Study contacts

Selin Bayram, Msc
Contact
selinbayram94@gmail.com
05327001805
Deran Oskay, Assoc. Prof
study director · Gazi University

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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