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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Multidimensional Fatigue Inventory-20 (MFI-20) | 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. | Baseline and 3-month |
| Measure | Description | Time Frame |
|---|---|---|
| EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) | ESSDAI is a clinician-reported index assessing systemic disease activity in Sjögren's syndrome across multiple domains including constitutional, glandular, articular, cutaneous, pulmonary, renal, muscular, peripheral and central nervous system, hematological, and biological features. Higher scores indicate greater disease activity. | Baseline and 3-month |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be recruited from the rheumatology outpatient clinics of Kahramanmaras Sutcu Imam University Medical Faculty Hospital. The study population will consist of adult patients diagnosed with Sjögren's disease who are followed in routine clinical care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nazli Elif Nacar, phd | Contact | +90 344 40 85 | nelifnacar@ksu.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kahramanmaras Sutcu Imam University | Recruiting | Kahramanmaraş | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D012859 | Sjogren's Syndrome |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) | ESSPRI is a patient-reported outcome measure evaluating fatigue, pain, and dryness using a 0-10 numerical rating scale. The final score is calculated as the mean of the three domains. Higher scores indicate worse symptom severity. | Baseline and 3-month |
| Pressure Pain Threshold (PPT) | PPT will be assessed using a digital pressure algometer applied at a constant rate of 50 kPa/s with a 1 cm² probe. Measurements will be taken bilaterally at predefined anatomical sites (trapezius muscle, thumb nail base, and knee). The mean of three consecutive measurements at each site will be recorded. A global PPT value will be calculated by averaging all sites. Higher values indicate lower pain sensitivity. | Baseline and 3-month |
| Hospital Anxiety and Depression Scale (HADS) | HADS is a 14-item self-report questionnaire assessing anxiety and depression. It consists of two subscales (anxiety and depression), each ranging from 0 to 21. Higher scores indicate greater psychological distress. | Baseline and 3-month |
| Pain Catastrophizing Scale (PCS) | The PCS is a 13-item self-report questionnaire assessing catastrophic thinking related to pain. Each item is rated on a 5-point Likert scale (0-4), with total scores ranging from 0 to 52. Higher scores indicate greater levels of pain catastrophizing. The scale includes three subdomains: rumination, magnification, and helplessness. | Baseline and 3-month |
| Pittsburgh Sleep Quality Index (PSQI) | The PSQI is a 19-item self-reported questionnaire assessing sleep quality over the past month. It generates a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. The instrument evaluates seven components including sleep quality, latency, duration, efficiency, disturbances, use of sleep medication, and daytime dysfunction. | Baseline and 3-month |
| International Physical Activity Questionnaire - Short Form (IPAQ-SF) | The IPAQ-SF is a 7-item questionnaire assessing physical activity levels over the last 7 days, including walking, moderate-intensity, and vigorous-intensity activities. Total physical activity is expressed as MET-minutes per week. Higher scores indicate higher levels of physical activity. | Baseline and 3-month |
| D012216 |
| Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D015352 | Dry Eye Syndromes |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |