原発性シェーグレン症候群における疲労
原発性シェーグレン症候群における疲労のレベルと疾患活動性、痛み、不眠症、心理測定パラメータとの関係
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Bursa
-
Yıldırım、Bursa、トルコ（Türkiye）、16310
- Koray Ayar
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Volunteers who were followed up with a diagnosis of PSS in the center where the study was conducted and met the inclusion and exclusion criteria.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：CASE_CONTROL
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Primary Sjögren's syndrome
The patient's diagnosed with Primary Sjögren's according to 2016 ACR/EULAR classification criteria |
The questionnaire, based on patient report outcome data in which the presence of fatique is investigated in participants. The questionnaire, based on patient report outcome data in which the presence of depression is investigated in participants. The questionnaire, based on patient report outcome data in which the presence of anxiety is investigated in participants. The questionnaire, based on patient report outcome data in which the presence of insomnia is investigated in participants. The questionnaire, based on patient report outcome data in which the severity of Sjögren's syndrome is investigated in participants. 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. The questionnaire, based on patient report outcome data in which the severity and extent of pain in the body are investigated in participants. |
|
Healthy Controls
Healthy hospital workers without any chronic disease |
The questionnaire, based on patient report outcome data in which the presence of fatique is investigated in participants. The questionnaire, based on patient report outcome data in which the presence of depression is investigated in participants. The questionnaire, based on patient report outcome data in which the presence of anxiety is investigated in participants. The questionnaire, based on patient report outcome data in which the presence of insomnia is investigated in participants. The questionnaire, based on patient report outcome data in which the severity and extent of pain in the body are investigated in participants. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
FACIT-F
時間枠：day 1
|
FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATİQUE |
day 1
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
BDI
時間枠：day 1
|
Beck Depression Inventory |
day 1
|
|
BAI
時間枠：day 1
|
Beck Anxiety Inventory |
day 1
|
|
ISS
時間枠：day 1
|
Insomnia Severity Scale |
day 1
|
|
PDQ
時間枠：day 1
|
Pain Detect Questionnaire |
day 1
|
協力者と研究者
捜査官
- 主任研究者：Koray Ayar, M.D.、Univesity of Health Science, Bursa Yuksek Ihtisas Training and Research Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2011-KAEK-25 2020/12-10
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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