Sjogren's Syndrome, Fatigue, Pain Syndrome, Depression, Anxiety, Fibromyalgia
Conditions
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTFACT-F questionnaire
The questionnaire, based on patient report outcome data in which the presence of fatique is investigated in participants.
DIAGNOSTIC_TESTBeck Depression Inventory
The questionnaire, based on patient report outcome data in which the presence of depression is investigated in participants.
DIAGNOSTIC_TESTBeck Anxiety Inventory
The questionnaire, based on patient report outcome data in which the presence of anxiety is investigated in participants.
DIAGNOSTIC_TESTInsomnia severity index.
The questionnaire, based on patient report outcome data in which the presence of insomnia is investigated in participants.
OTHERESSPRI
The questionnaire, based on patient report outcome data in which the severity of Sjögren's syndrome is investigated in participants.
OTHERESSDAI
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.
OTHERPain Detect Questionnaire
The questionnaire, based on patient report outcome data in which the severity and extent of pain in the body are investigated in participants.
Sponsors
Bursa Yuksek Ihtisas Training and Research Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FACIT-F | day 1 | FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATİQUE |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BDI | day 1 | Beck Depression Inventory |
| BAI | day 1 | Beck Anxiety Inventory |
| ISS | day 1 | Insomnia Severity Scale |
| PDQ | day 1 | Pain Detect Questionnaire |
Countries
Turkey (Türkiye)
Outcome results
None listed