Fatigue in Primary Sjögren's Syndrome

Study Overview
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Brief Summary
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Fatigue is a common clinical finding in Primary Sjögren's syndrome (PSS). In PSS, there is not enough data about the conditions in which fatigue develops and which clinical conditions the disease is associated with. This study was aimed to determine the level of fatigue in Primary Sjögren syndrome and to investigate the factors affecting the level of fatigue.

Detailed Description
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While fatigue is seen with a prevalence of 7-8% in the normal population, it is more prevalent in Primary Sjögren's syndrome (PSS). In the studies conducted so far, the frequency of fatigue was seen at a frequency of over 30% in Primary Sjögren's syndrome. Although fatigue is so common in PSS, there is not enough data about the conditions in which fatigue develops in PSS. Other common conditions in PSS, apart from fatigue, are psychometric disorders such as common pain, depression and anxiety, and sleep disorders. In the studies conducted so far, each situation mentioned is common in PSS and seems to be related to each other. In the literature, there is no data on how many psychometric parameters, pain level, and insomnia affect fatigue and which are independent risk factors in PSS.

Official Title
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The Level of Fatigue and Its Relationship With Disease Activity, Pain, Insomnia, and Psychometric Parameters in Primary Sjögren's Syndrome

Conditions
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Sjogren's Syndrome, Fatigue, Pain Syndrome, Depression, Anxiety, Fibromyalgia

Intervention / Treatment
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* Diagnostic Test: FACT-F questionnaire
* Diagnostic Test: Beck Depression Inventory
* Diagnostic Test: Beck Anxiety Inventory
* Diagnostic Test: Insomnia severity index.
* Other: ESSPRI
* Other: ESSDAI
* Other: Pain Detect Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with PSS according to the 2016 ACR / EULAR criteria Healthy hospital staff Exclusion Criteria: Pregnant women Cancer patients Those with other connective tissue diseases other than PSS Multiple sclerosis patients Chronic obstructive pulmonary disease Those with heart failure and adrenal insufficiency Those with renal failure: GFR <60 ml/min Anemia: Hemoglobin <11 g / dl in women, hemoglobin <12 g / dl in men Hypothyroidism: TSH >5 mu / L Those with electrolyte disturbance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Sjögren's syndrome<br>The patient's diagnosed with Primary Sjögren's according to 2016 ACR/EULAR classification criteria | Diagnostic Test: FACT-F questionnaire<br>* The questionnaire, based on patient report outcome data in which the presence of fatique is investigated in participants.<br>Diagnostic Test: Beck Depression Inventory<br>* The questionnaire, based on patient report outcome data in which the presence of depression is investigated in participants.<br>Diagnostic Test: Beck Anxiety Inventory<br>* The questionnaire, based on patient report outcome data in which the presence of anxiety is investigated in participants.<br>Diagnostic Test: Insomnia severity index.<br>* The questionnaire, based on patient report outcome data in which the presence of insomnia is investigated in participants.<br>Other: ESSPRI<br>* The questionnaire, based on patient report outcome data in which the severity of Sjögren's syndrome is investigated in participants.<br>Other: ESSDAI<br>* Activity scale in which the activity of Sjögren's syndrome is evaluated based on the laboratory and imaging tests of the patients and the examination findings of the evaluator.<br>Other: Pain Detect Questionnaire<br>* The questionnaire, based on patient report outcome data in which the severity and extent of pain in the body are investigated in participants.<br>|
| Healthy Controls<br>Healthy hospital workers without any chronic disease | Diagnostic Test: FACT-F questionnaire<br>* The questionnaire, based on patient report outcome data in which the presence of fatique is investigated in participants.<br>Diagnostic Test: Beck Depression Inventory<br>* The questionnaire, based on patient report outcome data in which the presence of depression is investigated in participants.<br>Diagnostic Test: Beck Anxiety Inventory<br>* The questionnaire, based on patient report outcome data in which the presence of anxiety is investigated in participants.<br>Diagnostic Test: Insomnia severity index.<br>* The questionnaire, based on patient report outcome data in which the presence of insomnia is investigated in participants.<br>Other: Pain Detect Questionnaire<br>* The questionnaire, based on patient report outcome data in which the severity and extent of pain in the body are investigated in participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FACIT-F | FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATİQUE | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BDI | Beck Depression Inventory | day 1 | 
| BAI | Beck Anxiety Inventory | day 1 | 
| ISS | Insomnia Severity Scale | day 1 | 
| PDQ | Pain Detect Questionnaire | day 1 |