- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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East Java
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Surabaya, East Java, Indonésia, 67161
- Dr. Soetomo General Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 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
|
Sem intervenção: Control group
No intervention during 2-week self-isolation period
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
State-Trait Anxiety Inventory (STAI)
Prazo: 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
|
2 weeks
|
Brief Resiliency Scale (BRS)
Prazo: 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)
Prazo: 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
|
2 weeks
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Cortisol
Prazo: 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 |
2 weeks
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CD4
Prazo: 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.
|
2 weeks
|
Interleukin-6 (IL-6)
Prazo: 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.
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2 weeks
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Neutrophil to lymphocyte ratio (NLR)
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Margarita M Maramis, MD, Ph.D, Dr. Soetomo General Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Sintomas Comportamentais
- Infecções por coronavírus
- Infecções por Coronaviridae
- Infecções por Nidovírus
- Infecções por vírus de RNA
- Doenças Virais
- Infecções
- Infecções do Trato Respiratório
- Doenças Respiratórias
- Pneumonia Viral
- Pneumonia
- Doenças pulmonares
- Estresse, Psicológico
- COVID-19
- Burnout, Psicológico
Outros números de identificação do estudo
- 0006/KEPK/V/2020
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
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Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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