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Recruiting Observational

Explanatory Factors and Predictors of Fatigue in Patients With Sjögren's Disease: A 3-month Longitudinal Study

NCT07544394 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-04-20
Last updated
2026-04-27

Condition(s) studied

Sjogren's DiseaseFatigue

Study summary

This prospective longitudinal study will be conducted in patients diagnosed with Sjögren's disease who are followed at the rheumatology outpatient clinic of Kahramanmaras Sutcu Imam University Medical Faculty Hospital. Demographic and clinical data will be collected from routine clinical assessments and medical records, including laboratory results obtained during standard care.

Participants will undergo evaluation of pressure pain threshold using a digital algometer and complete validated questionnaires assessing fatigue, disease activity, patient-reported symptoms, anxiety and depression, pain catastrophizing, sleep quality, and physical activity level.

All assessments will be performed at baseline and repeated at follow-up visits approximately 3 months later.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of Sjögren's syndrome * Age ≥ 18 years * Willingness to participate and provide written informed consent Exclusion Criteria: * Presence of severe somatic or psychiatric disorders * Presence of malignancy * Pregnancy * Refusal to participate or inability to provide written informed consent

Primary outcome measure(s)

  • Multidimensional Fatigue Inventory-20 (MFI-20) — Baseline and 3-month
    The MFI-20 is a 20-item self-reported questionnaire assessing fatigue across five dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity. Each item is scored on a 5-point Likert scale. Total scores range from 20 to 100, with higher scores indicating greater fatigue.

Trial sites (1)

FacilityCityRegionStatus
Kahramanmaras Sutcu Imam University Kahramanmaraş Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07544394 on ClinicalTrials.gov ↗ ← All trials in Turkey