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Clinical Trials/NCT04858464
NCT04858464
Unknown
N/A

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

Gazi University1 site in 1 country75 target enrollmentMay 2, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Primary Sjögren's Syndrome
Sponsor
Gazi University
Enrollment
75
Locations
1
Primary Endpoint
Primary Sjögren's Syndrome Quality of Life (PSS-QoL) Questionnaire
Last Updated
4 years ago

Overview

Brief 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

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.

Registry
clinicaltrials.gov
Start Date
May 2, 2021
End Date
May 2, 2023
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Selin Bayram

Msc

Gazi University

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with primary Sjögren's syndrome

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 10 minutes

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.

Study Sites (1)

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