The Level of Fatigue and Its Relationship With Disease Activity, Pain, Insomnia, and Psychometric Parameters in Primary Sjögren's Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- FACIT-F
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with PSS according to the 2016 ACR / EULAR criteria
- •Healthy hospital staff
排除标准
- •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
结局指标
主要结局
FACIT-F
时间窗: day 1
FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATİQUE
次要结局
- BAI(day 1)
- BDI(day 1)
- PDQ(day 1)
- ISS(day 1)
研究者
Koray Ayar
Assistant Professor
Bursa Yüksek İhtisas Education and Research Hospital