- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07576920
Anxiety Levels in Living Liver Donors
Evaluation of Preoperative and Postoperative Anxiety in Living Liver Donors
연구 개요
상세 설명
Liver transplantation is the only treatment for end-stage liver disease. The shortage of organ donations is leading clinicians to increasingly perform transplants from living donors. The biggest concern in living-donor liver transplantation is donor safety.
Liver donors undergo a major surgical operation that offers no medical benefit to them. The procedure can involve not only a physical but also a psychological burden. Given this situation, protecting both the physical and psychological health of liver donors is essential.
Anxiety studies primarily focus on organ transplant recipients However, the quality of life of donors and psychological conditions such as anxiety and depression are attracting increasing attention in the field of organ transplantation today. Neuropsychiatric Disease and Treatment 2018:14 1999-2005 A literature review revealed that there are limited studies investigating how donors are affected during the transplantation process in living-donor liver transplantation.
The aim of our study is to determine the preoperative and postoperative anxiety levels of donors in living donor liver transplantation and to identify possible conditions that may be associated with anxiety.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Zekine Begeç, Professor
- 전화번호: 3112 +904223410660
- 이메일: zekine.begec@inonu.edu.tr
연구 연락처 백업
- 이름: Muharrem Uçar, Professor
- 전화번호: 3112 +904223410660
- 이메일: umuharrem@hotmail.com
연구 장소
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Malatya, 터키 (Türkiye)
- 모병
- Turgut Ozal Medical Center
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수석 연구원:
- Zekine Begec
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연락하다:
- Zekine Begec, Dr
- 전화번호: +904223410660
- 이메일: zekine.begec@inonu.edu.tr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- ASA 1-2 group patients aged 18-65 years who are liver transplant donors
Exclusion Criteria:
- Patients with communication problems, those who are illiterate,
- Patients do not have sufficient time for the tests,
- Patients using sedatives, antidepressants, or antiepileptic drugs,
- Patients with cerebrovascular or psychiatric diseases,
- Patients with alcohol or substance addiction,
- Patients who do not want or cannot undergo the second test
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Living liver donors
Liver transplant donors who will undergo surgery between May and July 2026
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Anxiety scores will evaluated STAI test.
The STAI test consists of two sections of 20 questions each.
The first section of the test includes questions about how the person feels at that moment.
Answers are given on a scale of 4 points.
For example: I am calm right now: not at all=1, a little=2, a lot=3, completely=4.
The second section of the test includes questions about how the person feels in general and is also answered on a scale of 4 points.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Anxiety Scores
기간: From 24 hours prior to the operation to postoperative 3. day and 7. day
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The STAI test is a questionnaire comprising two, 20-item scales used to measure state and trait anxiety.
The anxiety levels of LLDs will be evaluated by using the STAI.
The STAI-State (STAI-S) form will be use to measure the current anxiety level.
The test includes questions about how the person feels at that moment.
Answers are given on a scale of 4 points.
For example: I am calm right now: not at all=1, a little=2, a lot=3, completely=4.
The STAI-Trait (STAI-T) form will be use to measure the underlying (ongoing/personality) anxiety level of the patient.
The test includes questions about how the person feels in general and is also answered on a scale of 4 points.
Each patient will complete these forms preoperatively and postoperatively.
The mean (total) score on the STAI has a minimum of 20 and a maximum of 80.
The STAI scores are generally classified as no anxiety or low anxiety (score of 20-37), moderate anxiety (score of 38-44), and high anxiety (score of 45-80).
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From 24 hours prior to the operation to postoperative 3. day and 7. day
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Presence of an alternative donor
기간: Prior to the operation
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The relationship between the presence or absence of an alternative donor and donors anxiety scores will be evaluated.
This will be defined as "alternative donor available" or "alternative donor not available."
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Prior to the operation
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Recipient Prognosis
기간: at the postoperative 3. day and 7. day
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The relationship between the recipients prognosis and donors anxiety scores will be evaluated.
This will be defined as the recipient living or not living
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at the postoperative 3. day and 7. day
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Zekine Begeç, professor, Inonu University Department of Anesthesia
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
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. .