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临床试验/NCT05246124
NCT05246124已完成不适用

The Effect of Demographic, Mental, and Physical Activity Profiles Towards Burnout in Frontline Healthcare Workers Facing COVID-19 Pandemics in RSUD Dr. Soetomo Surabaya

Dr. Soetomo General Hospital2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2020年5月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
61
试验地点
2
主要终点
Cortisol

研究概览

简要总结

This was a randomized controlled trial study to measure the effect of intervention of Zumba dance towards psychological and biological markers in hospital residents managing COVID-19 patients

详细描述

A study to compare the effect of Zumba dance exercise towards psychological and biological markers in control and intervention groups of residents managing COVID-19 patients. Psychological markers were assessed using State Trait Anxiety Inventory (STAI), Brief Resilience Scale (BRS), and Maslach Burnout Inventory (MBI) questionnaires. Biological markers being measured were neutrophil to lymphocyte ratio (NLR), CD4, Interleukin-6 (IL-6), and salivary cortisol. Measurements were done at the beginning of self-isolation after shift and 2 weeks after self-isolation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Residents of anesthesiology and internal medicine department at Dr. Soetomo General Hospital Surabaya
  • Residents managing COVID-19 patients in the special isolation room

排除标准

  • 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.

结局指标

主要结局

Cortisol

时间窗: 2 weeks

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

Neutrophil to lymphocyte ratio (NLR)

时间窗: 2 weeks

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.

State-Trait Anxiety Inventory (STAI)

时间窗: 2 weeks

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

Brief Resiliency Scale (BRS)

时间窗: 2 weeks

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

Maslach Burnout Inventory (MBI)

时间窗: 2 weeks

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

CD4

时间窗: 2 weeks

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.

Interleukin-6 (IL-6)

时间窗: 2 weeks

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.

次要结局

未报告次要终点

研究者

发起方
Dr. Soetomo General Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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