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.

Study Overview

• Status: Recruiting
• Conditions: Fatigue; Sjogren's Disease

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Nazli Elif Nacar, phd; Phone Number: +90 344 40 85; Email: nelifnacar@ksu.edu.tr

Study Locations

• Turkey (Türkiye)
  • Kahramanmaraş, Turkey (Türkiye)
    • Recruiting
    • Kahramanmaraş Sütçü İmam University
    • Contact: Nazli Elif Nacar, PhD; Phone Number: +90 344 300 40 85; Email: nelifnacar@ksu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): April 20, 2028

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Fatigue; Sjogren's Syndrome
• Other Study ID Numbers: KSU-2026/03-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No