원발성 쇼그렌 증후군의 피로
원발성 쇼그렌 증후군에서 피로 정도와 질병 활성도, 통증, 불면, 정신측정학적 변수와의 관계
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
Bursa
-
Yıldırım, Bursa, 터키 (Türkiye), 16310
- Koray Ayar
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_CONTROL
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
FACIT-F
기간: day 1
|
FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATİQUE |
day 1
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
BDI
기간: day 1
|
Beck Depression Inventory |
day 1
|
|
BAI
기간: day 1
|
Beck Anxiety Inventory |
day 1
|
|
ISS
기간: day 1
|
Insomnia Severity Scale |
day 1
|
|
PDQ
기간: day 1
|
Pain Detect Questionnaire |
day 1
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Koray Ayar, M.D., Univesity of Health Science, Bursa Yuksek Ihtisas Training and Research Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2011-KAEK-25 2020/12-10
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .