Fatigue in Systemic Lupus Erythematosus
- Conditions
- FatigueSystemic Lupus Erthematosus
- Registration Number
- NCT06652256
- Lead Sponsor
- Pamukkale University
- Brief Summary
The aim of this study is to investigate the effects of biopsychosocial status, quality of life, functional status and hematological markers on fatigue in individuals with SLE.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 39
- Being diagnosed with SLE according to the 2019 ACR/EULAR diagnostic criteria
- Being 18 years of age or older
- Not being able to speak or understand Turkish fluently
- Having a psychiatric illness that will affect cooperation
- Heart failure or lung pathology that will affect daily life activities
- Additional autoimmune disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fatigue Assesment Scale Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period. It is a scale consisting 10 items. The maximum score is 50. High score indicates high fatigue.
FACIT Fatigue Scale Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period. It is scale consisting 13 items. Scores range from 0-52. High score indicates low fatigue
- Secondary Outcome Measures
Name Time Method Cognitive Exercise Therapy Approach-Biopsychosocial Questionnaire (BETY-BQ) Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period. It is a scale consist of 30 items. Scores range from 0-120. Higher scores indicate worse biopsychosocial status.
Short Form 36 (SF-36) Health Survey Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period. The SF-36 consists of two dimensions, generating a profile of health-related quality of life.These dimensions are: physical health and mental health. Higher scores indicate better health.
HEALTH ASSESSMENT QUESTIONNAIRE (HAQ) Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period. The scale consists of 20 questions and includes 8 activities. The total score is obtained by summing the points earned from 8 activities and then dividing that sum by 8. Higher scores indicate worse functional status
Routine blood test results Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period. Participants' routine blood test results such as neutrophil (NEU (K/uL)) , monocyte (MONO (K/uL)), eosinophil (EO (K/uL)), leukocyte (WBC (K/uL)), lymphocyte (LYM (K/uL)), platelet (PLT (K/uL)) will be recorded.
Routine Blood Test Results Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period. Sedimentation (mm/h) will be recorded.
Hematological indices Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period. Neutrophil/lymphocyte (NLR), monocyte/lymphocyte (MLR), platelet/lymphocyte (PLR), platelet\*neutrophil/lymphocyte (systemic inflammatory index), monocyte/platelet (MTO), neutrophil\*monocyte/lymphocyte (systemic inflammatory response index), neutrophil\*monocyte\*platelet/lymphocyte (systemic inflammation aggregate index) obtained from complete blood counts will be calculated and recorded.
Trial Locations
- Locations (1)
Pamukkale University
🇹🇷Denizli, Turkey