Actively Recruiting
Explanatory Factors and Predictors of Fatigue in Patients With Sj f6gren's Disease: A 3-Month Longitudinal Study
Led by Kahramanmaras Sutcu Imam University · Updated on 2026-04-27
100
Participants Needed
1
Research Sites
16 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study fatigue and its causes in adult patients diagnosed with Sj f6gren's disease who are followed at a rheumatology outpatient clinic. The study focuses on understanding how clinical, psychological, and social factors relate to fatigue over time. It involves observing patients in their routine clinical care setting without adding experimental treatments. Participants will have their demographic and clinical data collected from medical records and routine laboratory tests. They will undergo pressure pain threshold testing using a digital algometer and complete validated questionnaires that assess fatigue, disease activity, symptoms reported by the patient, anxiety and depression levels, pain catastrophizing, sleep quality, and physical activity. These assessments are done at the start and repeated during follow-up visits approximately 3 months later. Participants will be involved in two main assessment visits: baseline and follow-up about 3 months later. During these visits, clinical data and laboratory results will be collected, and they will complete various questionnaires and pain sensitivity tests. Researchers will measure fatigue using the Multidimensional Fatigue Inventory-20 and evaluate other factors such as disease activity, psychological status, pain sensitivity, sleep quality, and physical activity. The study monitors these measures over time to explore what factors predict changes in fatigue.
CONDITIONS
Brief Title
Explanatory Factors and Predictors of Fatigue in Patients With Sjögren's Disease: A 3-month Longitudinal Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Sj�f6gren's syndrome
- Age 18 years or older
- Willingness to participate and provide written informed consent
You will not qualify if you...
- Presence of severe somatic or psychiatric disorders
- Presence of malignancy
- Pregnancy
- Refusal to participate or inability to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo baseline assessments including demographic and clinical data collection, routine laboratory tests, pressure pain threshold measurement, and complete questionnaires on fatigue, disease activity, symptoms, anxiety, depression, pain catastrophizing, sleep quality, and physical activity.
1 visit (in-person)
Duration - Approximately 3 months
Participants are observed over a 3-month period without active intervention. Follow-up assessments repeat all baseline measurements to evaluate changes over time.
1 visit (in-person) at 3 months
Trial Site Locations
Total: 1 location
1
Kahramanmaras Sutcu Imam University
Kahramanmaraş, Turkey (Türkiye)
Actively Recruiting
Research Team
N
Nazli Elif Nacar, phd
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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