- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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East Java
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Surabaya, East Java, Индонезия, 67161
- Dr. Soetomo General Hospital
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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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Без вмешательства: Control group
No intervention during 2-week self-isolation period
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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State-Trait Anxiety Inventory (STAI)
Временное ограничение: 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
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2 weeks
|
|
Brief Resiliency Scale (BRS)
Временное ограничение: 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
|
2 weeks
|
|
Maslach Burnout Inventory (MBI)
Временное ограничение: 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
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2 weeks
|
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Cortisol
Временное ограничение: 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
Временное ограничение: 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.
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2 weeks
|
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Interleukin-6 (IL-6)
Временное ограничение: 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)
Временное ограничение: 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.
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2 weeks
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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Margarita M Maramis, MD, Ph.D, Dr. Soetomo General Hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Поведенческие симптомы
- Коронавирусные инфекции
- Коронавирусные инфекции
- Нидовирусные инфекции
- РНК-вирусные инфекции
- Вирусные заболевания
- Инфекции
- Инфекции дыхательных путей
- Заболевания дыхательных путей
- Пневмония, вирусная
- Пневмония
- Легочные заболевания
- Стресс, Психологический
- COVID-19
- Выгорание, Психологическое
Другие идентификационные номера исследования
- 0006/KEPK/V/2020
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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