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临床试验/NCT04975087
NCT04975087Unknown不适用

Reliability, Validity, and Cross-cultural Adaptation of the Turkish Version of the Profile of Fatigue and Discomfort - Sicca Symptoms Inventory in Sjogren Patients

Gazi University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年10月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
the Profile of Fatigue and Discomfort - Sicca Symptoms Inventory

研究概览

简要总结

Primary Sjögren's syndrome (pSS) is a chronic, systemic autoimmune disease characterized by disorders of the lacrimal and salivary glands. The disease can be seen in systemic involvement by affecting any organ. It may result in skin, lung and kidney involvement as well as symptoms such as vasculitis and neuropathy. Patients with PSS often report fatigue as an important symptom to manage. Fatigue, defined as an overwhelming feeling of fatigue, lack of energy, and exhaustion, is associated with poor health and functional impairment.

Fatigue is a common symptom of pSS. This symptom is the most important cause of loss of function in patients. It is thought that as a result of fatigue in pSS, decrease in mental health related to physical activity level and quality of life in patients, sleep problems, depression and loss of ability to work. Several mechanisms have been proposed to explain the occurrence of fatigue among sjogren patients, but its underlying physiological basis has not been adequately defined. Therefore, it is a complex, multifaceted and poorly understood symptom.

In population-based studies, approximately 20% of healthy adults report experiencing fatigue, and this rate rises to 60%-70% among patients with autoimmune disorders. Fatigue is the most common non-exocrine symptom in pSS, and the prevalence of fatigue disability among patients with pSS has been reported to be approximately 70%.

详细描述

In order to evaluate fatigue in primary Sjögren's syndrome patients, questionnaires such as FACIT Fatigue Scale, Sjögren's Syndrome EULAR Patient Reporting Index, Fatigue Severity Scale, Fatigue Multidimensional Assessment Scale and Short Form-36, which are also used in many disease groups, are used. Although the importance of the effect of fatigue on pSS patients has been demonstrated in studies, most of the fatigue assessment questionnaires used are not pSS specific. For this reason, Bowman et al. They developed the Fatigue and Discomfort Profile - Sikka Symptoms Scale (PROFAD-SSI) to assess multidimensional fatigue in patients with pSS, considering disease symptoms. PROFAD-SSI is scored from 0 to 7 on an 8-point Likert scale. The 19-item scale evaluates patients in 8 different dimensions: somatic fatigue, mental fatigue, arthralgia, vascular dysfunction, oral dryness, ocular dryness, cutaneous and vaginal dryness.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with primary Sjögren's syndrome
  • Patients between the ages of 18-65
  • Being literate

排除标准

  • Having cognitive disorders
  • Having another rheumatological diseases

结局指标

主要结局

the Profile of Fatigue and Discomfort - Sicca Symptoms Inventory

时间窗: 10 minutes

It is scored between 0-7 on an 8-point Likert scale. The 19-item scale evaluates patients in 8 different dimensions: somatic fatigue, mental fatigue, arthralgia, vascular dysfunction, oral dryness, ocular dryness, cutaneous and vaginal dryness.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fulden Sarı

research assistant

Gazi University

研究点 (1)

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