Comprehensive Evaluation of Clinical and Biopsychosocial Characteristics in Primary Sjögren's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Xerostomia inventory
研究概览
简要总结
Following the guidance of individuals with primary Sjögren's Syndrome who receive diagnosis, routine medical care, and treatment management, the evaluations will be performed once by the researchers and will take approximately one hour.
In addition, healthy individuals with a similar average age to the evaluation group without any disease diagnosis will be included in the study as a control group. Evaluations of the healthy group will be made once by the researchers and will take approximately one hour.
Data will be collected face to face at the Faculty of Physical Therapy and Rehabilitation, Rheumatology Unit.
Data collection tool of the research:
- Information about patients will be recorded with the Demographic Information Form.
- EULAR Sjögren's Syndrome Disease Activity Index
- EULAR Sjögren's Syndrome Patient Reporting Index
- Primary Sjögren's Syndrome Quality of Life Scale
- BETY-Biopsychosocial Questionnaire
- Central Sensitization Scale
- Pain Catastrophizing Scale
- Hospital Anxiety and Depression Scale
- Multidimensional Fatigue Rating Scale
- Turkish Eating Assessment Tool
- Yale Swallow Protocol
- Test of Mastication and Swallowing Solids
- Dysphagia Limit Test
- Xerostomia inventory
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with Primary Sjögren's Syndrome
- •18 years or older
排除标准
- •Patients with Secondary Sjögren's Syndrome,
- •Patients who are diagnosed with other uncontrolled/clinically important diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.),
- •Having a malignant condition,
- •Pregnant individuals in the third trimester,
- •Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.
结局指标
主要结局
Xerostomia inventory
时间窗: baseline
The scale consists of 11 items. Patients will be asked to choose the best response for each item describing their symptoms over the previous two weeks. Responses are scored from 1 to 5 (1: never, 2: rarely, 3: occasionally, 4: fairly often, and 5: very often). The sum of the item scores gives a total score ranging from 11 to 55, and a higher score indicates that the symptoms are more severe.
BETY-Biopsychosocial Questionnaire (BETY-BQ)
时间窗: baseline
BETY-BQ consists of the following six subtitles that investigate in detail the biopsychosocial dimensions: pain, functionality and fatigue, mood, sociability, sexuality, and sleep quality. This scale consists of 30 items, scored on a 5-point Likert system. Each question is scored as "No never: 0 Yes rarely: 1 Yes sometimes: 2 Yes often: 3 Yes always: 4" and a total score over 30 items. A higher score indicates a poorer biopsychosocial situation.
Turkish Eating Assessment Tool
时间窗: baseline
Turkish Eating Assessment Tool is a survey consisting of 10 questions with a Likert scale between 0 and 4 (0 = no problem, 4 = severe problem). The total score is calculated out of 40 points by finding the sum of the answers given by individuals to each question. A score of 3 or more in the survey is considered abnormal. A score of 16 or above is considered as suspicion of aspiration.
Multidimensional Fatigue Rating Scale
时间窗: baseline
This scale evaluates fatigue with 16 items under 5 subheadings: degree, severity, impact on daily activities, troubles it causes, and fatigue time. The score ranges from 0 (not tired) to 50 (extremely tired).
Test of Mastication and Swallowing Solids
时间窗: baseline
In our study, the Test of Masticating and Swallowing Solids (TOMASS) will be used. The test evaluates how many bites the individual takes to eat a biscuit while sitting upright, how many chewing cycles he makes, how many times he swallows it, and how long the total time is from biting to swallowing. Video recording will be taken during the test. The number of bites, number of chewing cycles, number of swallows and total time will be calculated on the video.
Hospital Anxiety and Depression Scale (HADS)
时间窗: baseline
In this scale consisting of fourteen questions, odd-numbered questions questioning anxiety, and even questions question depression. Options range from 0 to 3, with a higher score indicating a poor emotional state. The cut-off values of the scale were determined as 10 for the anxiety subscale and 7 for the depression subscale.
Dysphagia limit
时间窗: baseline
While evaluating dysphagia, individuals are given 5, 10, 15, 20, 25, 30, 35, 40 and 45 mL volumes of liquid, respectively, with a graduated syringe and are asked to swallow the liquid. The maximum amount of fluid that the thyroid cartilage can swallow during a single movement is determined. The normal dysphagia limit in healthy individuals is more than 20 mL. If a person can swallow 20 mL normally, the dysphagia limit is normal.
次要结局
- Pain Catastrophizing Scale(baseline)
- EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI)(baseline)
- Central Sensitization Scale(baseline)
- EULAR Sjögren's Syndrome Patient Reporting Index (ESSPRI)(baseline)
- Primary Sjögren's Syndrome Quality of Life Scale(baseline)
- Yale Swallow Protocol(baseline)
研究者
Nazli Elif Nacar
Lecturer
Kahramanmaras Sutcu Imam University