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

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

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.

This prospective longitudinal study aims to investigate predictors of fatigue and its associations with clinical and biopsychosocial factors in patients with Sjögren's disease.

The study will be conducted in the rheumatology outpatient clinic of Kahramanmaras Sutcu Imam University Medical Faculty Hospital. Adult patients diagnosed with Sjögren's disease and followed in routine clinical care will be included.

Baseline assessments will include demographic and clinical data collection from medical records and routine laboratory tests. In addition, participants will undergo evaluation of pain sensitivity using pressure pain threshold (PPT) measurement and complete validated questionnaires assessing fatigue, disease activity, patient-reported symptoms, anxiety and depression, pain catastrophizing, sleep quality, and physical activity.

Follow-up assessments will be performed approximately 3 months later and all baseline measurements will be repeated.

The primary aim of the study is to evaluate whether baseline clinical and biopsychosocial variables explain variations in fatigue over time. Secondary aims include examining the associations between fatigue and pain sensitivity, psychological status, sleep quality, and physical activity levels.

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