- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05246124
The Effect of Demographic, Mental, and Physical Activity Profiles Towards Burnout in Frontline Healthcare Workers Facing COVID-19 Pandemics in Dr. Soetomo General Hospital Surabaya
The Effect of Demographic, Mental, and Physical Activity Profiles Towards Burnout in Frontline Healthcare Workers Facing COVID-19 Pandemics in RSUD Dr. Soetomo Surabaya
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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East Java
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Surabaya, East Java, 인도네시아, 67161
- Dr. Soetomo General Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Residents of anesthesiology and internal medicine department at Dr. Soetomo General Hospital Surabaya
- Residents managing COVID-19 patients in the special isolation room
Exclusion Criteria:
- Residents that did not fill in the questionnaires completely
- Residents with comorbidities (diabetes, hypertension, heart disease or autoimmune disorders)
- Residents that were infected with COVID-19
- Residents currently or previously diagnosed with psychosis
- Residents refusing to participate in the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Intervention group
This study used Zumba dance exercise done 3 times a week during 2-week self-isolation period, with each session lasting for 50 minutes.
The participants did exercise by following instructions from Zumba video shown
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The intervention was Zumba dance done 3 times a week during the 2-week self-isolation period, with each session lasting for 50 minutes.
The participants did exercise by following instructions from Zumba video shown
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간섭 없음: Control group
No intervention during 2-week self-isolation period
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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State-Trait Anxiety Inventory (STAI)
기간: 2 weeks
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State anxiety (STAI-S) is the presence subjective feeling of fear and tension, also the occurrence of autonomic nervous activation responding to dangerous or threatening condition.
Trait anxiety (STAI-T) is a more stable aspect of tendency towards anxiety, including calmness, self-esteem, and feeling secure.
STAI contains 40 statements with the score interpretation ranging from 20-80.
The score between 20-37 means having low or no anxiety, 38-44 indicates medium anxiety, and 45-80 suggests high anxiety
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2 weeks
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Brief Resiliency Scale (BRS)
기간: 2 weeks
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BRS consists of six questions, with three positive statements and three negative statements.
Participants choose one of the five responses to the statements, ranging from "strongly disagree" to "strongly agree".
There are three categories of results: low
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2 weeks
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Maslach Burnout Inventory (MBI)
기간: 2 weeks
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The MBI scoring is divided into dimensions of burnout such as emotional exhaustion (EE), depersonalization (DP), and personal accomplishment (PA).
The 22-items questionnaire evaluates these domains of burnout, containing 9 items for emotional exhaustion (MBI-EE), 5 items for depersonalization (MBI-DP), and 8 items for personal accomplishment (MBI-PA).
Each item is rated using a Likert scale, measuring the experience of the participants, ranging from never (0) to everyday (6).
The MBI-EE score consists of high for total score ≥ 30, moderate for 18-28, and low for ≤ 17.
The MBI-DP score comprises high for total score ≥ 12, moderate for 6-11, and low for ≤ 5.
As for the MBI-PA, it is considered low for a total score ≤ 33, moderate for 34-39, and high for ≥ 40
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2 weeks
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Cortisol
기간: 2 weeks
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Unstimulated saliva samples, using the passive drooling method, were collected from each participant. The participants should not eat or drink anything at least 1 hour prior to the saliva collection. Also, the participants were instructed to brush their teeth and wash their oral cavities with sterilized water. Samples were kept cold using cooler box and transported to the laboratory. In the laboratory, samples were immediately centrifuged 1700xg at 4°C for 10 minutes within one hour after collection, Samples were aliquoted and stored at -80°C for further analysis of cortisol level. Determination of saliva cortisol was performed using a cortisol enzyme immunoassay kit. Samples (25 µL) were treated according to the manufacturer's instructions. The optical density of the samples and standards were measured at a wavelength of 450 nm by a microplate reader |
2 weeks
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CD4
기간: 2 weeks
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5 ml blood samples were collected from median cubital vein using a standardized venipuncture technique in EDTA tube for CD4 analysis.
Blood samples were centrifuged 2500 rpm for 15 minutes.
The serum were then aliquoted and stored at -80°C.
CD4 were analyzed by flowcytometry according to the manufacturer's instruction.
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2 weeks
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Interleukin-6 (IL-6)
기간: 2 weeks
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5 ml blood samples were collected from median cubital vein using a standardized venipuncture technique in serum separator tube (SST) for Interleukin 6. Blood samples were centrifuged 2500 rpm for 15 minutes.
The serum were then aliquoted and stored at -80°C.
Quantification of Interleukin-6 used commercial ELISA kit according to the manufacturer's instructions.
The optical density of the samples and standards were measured by a microplate reader.
Samples' concentration was calculated according to the relevant standard curve.
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2 weeks
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Neutrophil to lymphocyte ratio (NLR)
기간: 2 weeks
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5 ml blood samples were collected from median cubital vein using a standardized venipuncture technique in EDTA tube for NLR analysis.
NLR were analyzed by flowcytometry according to the manufacturer's instruction.
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2 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Margarita M Maramis, MD, Ph.D, Dr. Soetomo General 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
- 0006/KEPK/V/2020
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. .
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