- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03394898
Evaluation of Body Mass Index and Eating Behaviour Changes in Female Patients With Fibromyalgia Under Medical Treatment
Prospective, Observational Study of Evaluation of Body Mass Index and Eating Behaviour Changes in Female Patients With Fibromyalgia Under Medical Treatment
연구 개요
상세 설명
The female patients with fibromyalgia under medical treatment say that body mass index and eating behaviour changes,for this reason, this relationship will be investigated in this study.
Demographic data (sex, age, education level, occupation) of patients with fibromyalgia diagnosis will be questioned and height lengths will be measured. The group of medications (serotonin and norepinephrine reuptake inhibitor or GABAergic drugs) that begins with the diagnosis of the disease fibromyalgia will be recorded.
All patients will be assessed when diagnosed, followed by 2nd week and then 4nd week.
In each follow-up, the patients' weights will be measured again (the body mass index will be calculated from the measured value).
In each follow-up, the effect of fibromyalgia on the daily life of the patients will be questioned with Fibromyalgia Impact Questionnaire (FIQ). The FIQ was developed from information gathered from patient reports, functional status instruments, and clinical observations. This instrument measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being over the past week.
In each follow-up, patients' eating behaviour will be questioned with Three Factor Eating Questionnaire. The 18-item Three-Factor Eating Questionnaire is a scale that measures three domains of eating behavior: cognitive restraint , uncontrolled eating and emotional eating.
In each follow-up, the right calf circumference of the patients will be measured in centimeters with a tape measure .
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Istanbul, 칠면조, 34255
- 모병
- Gaziosmanpasa Taksim Research and Education Hospital
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연락하다:
- Ömer Necati Develioğlu, MD
- 전화번호: +90 212 945 30 00
- 이메일: taksimetikkurul@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Female subjects between the ages of 18-40
- Subjects, who met the 2013 American College of Rheumatology (ACR) criteria for Fibromyalgia
Exclusion Criteria:
- History of eating disorders such as anorexia nervosa, bulimia nevroza
- History of hypothyroidism or hyperthyroidism
- Pregnant or breast feeding
- History of central or peripheral nervous system disorders
- History of infectious, chronic inflammatory disease, malignant tumors
- Subjects with active psychiatric illness or who use psychiatric medication
- Uncooperative subject
- History of cardiac pathology such as heart failure, coronary artery disease
- History of diabetes, chronic renal insufficiency, chronic liver failure
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
eating behaviour
기간: 7 days
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Patients' eating behaviour will be questioned with Three Factor Eating Questionnaire.
The 18-item Three-Factor Eating Questionnaire is a scale that measures three domains of eating behavior: cognitive restraint , uncontrolled eating and emotional eating.
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7 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
activities of daily living
기간: 7 days
|
The effect of fibromyalgia on the daily life of the patients will be questioned with Fibromyalgia Impact Questionnaire (FIQ).
The FIQ was developed from information gathered from patient reports, functional status instruments, and clinical observations.
This instrument measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being over the past week.
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7 days
|
calf circumference
기간: 1 day
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The right calf circumference of the patients will be measured in centimeters with a tape measure .
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1 day
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body mass index
기간: 1 day
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The patients' weights and heights will be measured and the body mass index will be calculated from the measured values.
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1 day
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공동 작업자 및 조사자
수사관
- 수석 연구원: alper MENGİ, M.D., Gaziosmanpasa Taksim Training and Research Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
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 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. .