The Effect of Neurofeedback-assisted Mindfulness Training in Employees With Emotional Labor
9 de janeiro de 2019 atualizado por: Seoul National University Hospital
The Effect of Neurofeedback-assisted Mindfulness Training on Stress Reduction in Employees With Emotional Labor
The purpose of this study is to verify the effect of neurofeedback-assisted mindfulness training for workers.
Subjects who can participate in the screening are assigned to one neurofeedback-assisted mindfulness training group, mindfulness only training group, and self-treatment group.
The neurofeedback-assisted mindfulness group and the mindfulness group meet with psychologist and have education for the mindfulness training with or without neurofeedback respectively, a total of 4 times, once a week.
On the other hand, the self-treatment group provides self-education by providing the stress education kit.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
After screening, Pre-evaluation is conducted on the subjects who agreed to participate in the study.
Pre-assessment includes questionnaires related to stress, emotional labor, resilience, sleep, etc., and includes stress-related physiological measures using HRV, 2 lead EEG.
After the pre-evaluation, the neurofeedback-assisted mindfulness and mindfulness training group will have education sessions with a psychologist for 30 minutes at a time, once a week, for a total of 4 sessions (one month for a period).
The education includes the instruction of the application including mindfulness training, with or without neurofeedback, and the review for the accomplishment of the training.
Participants should follow the instruction and the training schedule which is arranged in advance.
On the other hand, for a self-care control, the education sessions are not provided and self-learning materials are provided once a week.
The purpose of the study is to find the effectiveness of mindfulness training on reduction of stress and severity of emotional labor.
Especially, mindfulness training group with neurofeedback might be expected to show the highest improvement in various clinical scales and biomarkers including EEG and HRV.
Tipo de estudo
Intervencional
Inscrição (Real)
96
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Gyeonggi-do
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Seongnam, Gyeonggi-do, Republica da Coréia, 13605
- Seoul National University Bundang Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
19 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Workers over the age of 19 and under 65
- In the Perceived Stress Scale 14 points or more
- If you are currently taking medication due to psychiatric illnesses such as depression, anxiety disorder, insomnia, etc., the dose must be stabilized for last 6 months, is expected to have no change in drug dose during the clinical trial
- If you understand the protocol and voluntarily agree to participate
- If you have an Android phone
Exclusion Criteria:
- Age under 19, adult over 65
- If you have dementia, intellectual disability, or other cognitive impairment
- If you have convulsive disorder, stroke, or other neurological disorder
- If you have psychosis such as schizophrenia or bipolar disorder or you have a history
- If you have a disease that can affect the reliability of HRV test, such as heart disease or lung disease.
- Has received non-pharmacological psychiatric or counseling treatment within the current or last 6 months.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Mindfulness training with neurofeedback
mindfulness training with neurofeedback using mobile application instruction and review of the application will be provided
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mindfulness training using mobile application
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Comparador Ativo: Mindfulness training
mindfulness training using mobile application instruction and review of the application will be provided
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mindfulness training using mobile application
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Sem intervenção: Self-care
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks
Prazo: Baseline and after 4, 8 weeks later
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The full name: Perceived Stress Scale - 10 item form 14-item scale developed by Cohen et al. (1983) that emphasizes subjective perception of stress.
Measures the degree of perceived unforeseeable, uncontrollable, and overwhelming experience of stress in the past month.
Although the 14-item PSS tend to exhibit good reliability, four of the items tend to perform poorly when evaluated using exploratory factor analysis (Cohen et al., 1988).
As a result, the PSS is commonly implemented using the 10-item form.
The questions are rated on 5-point Likert scale; 0 (never), 1 (almost never), 2 (sometimes), 3 (fairly often), 4 (very often).
Higher scores represent worse outcomes.
The scores of each scale sum into the total score.
Thus the total score ranges from 0 to 40.
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Baseline and after 4, 8 weeks later
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline Korean Emotional Labor Assessment Tool score
Prazo: Baseline and after 4, 8 weeks later
|
The total of 26 items were Emotional expression and control 5 items, organizational monitoring and management system 4 items, forced customer response 4 items, emotional damage 6 items, organizational protection system 7 items, and organizational protection system is reverse coding and summed up. 4 point Likert scale (1 = not at all, 5 = very much), and the possible total score ranges from 26 to 130 points.
The higher the score, the more emotional labor means.
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Baseline and after 4, 8 weeks later
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Change from baseline Korean abbreviation of Occupational Stress Scale (KOSS) score
Prazo: Baseline and after 4, 8 weeks later
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total of 24 items were used, and each item was not at all (from 1 point) to very much (5 points).
The higher the score, the more the job stress means.
Job demand, Insufficient job control, job insecurity, interpersonal conflict, Organizational system, Lack of reward and Occupational climate.
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Baseline and after 4, 8 weeks later
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Change from baseline Patient Health Questionnaire 9 (PHQ-9) score
Prazo: Baseline and after 4, 8 weeks later
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The total score is 0 to 27, and the higher the total score, the more severe the depressive symptoms.
Cutpoints of 5, 10, 15 and 20 represent the thresholds for mild, moderate, moderate severe, and severe depression, respectively.
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Baseline and after 4, 8 weeks later
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Change from baseline Brief resilience scale (BRS) score
Prazo: Baseline and after 4, 8 weeks later
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It is composed of 6 questions and is evaluated on the 5-point scale (1: not at all, 5: very much)
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Baseline and after 4, 8 weeks later
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Change from baseline Athens Insomnia Scale (AIS) score
Prazo: Baseline and after 4, 8 weeks later
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total score of 6 points was used as a breakpoint, this Using the quality index of Pittsburgh Sleep, which is widely used to evaluate the quality of sleep
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Baseline and after 4, 8 weeks later
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Korean Mindful Attention Awareness Scale; K-MAAS
Prazo: Baseline and after 4, 8 weeks later
|
Modified from the Mindful Attention Awareness Scale, developed by Brown and Ryan (2003).
15-item scale designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present.
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Baseline and after 4, 8 weeks later
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Stroop test
Prazo: Baseline and after 4, 8 weeks later
|
assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute
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Baseline and after 4, 8 weeks later
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Heart Rate Variability (HRV)
Prazo: Baseline and after 4, 8 weeks later
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HRV is recorded with a device (neuroNicle FX2, Laxtha) which include EEG and HRV recording system.
HRV is calculated from pulse rate signal recorded at earlobe.
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Baseline and after 4, 8 weeks later
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Quantitative electroencephalography (QEEG)
Prazo: Baseline and after 4, 8 weeks later
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EEG is recorded with a device (neuroNicle FX2, Laxtha) which include EEG and HRV recording system. EEG signal is acquired at the prefrontal area, two channels (FP1, FP2) on forehead. Power spectrum analysis of the EEG data will be performed using Fourier analysis. And absolute power, relative power, of each frequency band, symmetry are included. |
Baseline and after 4, 8 weeks later
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jeong Hyun Kim, MD, Ph.D, Seoul National Univerysity Bundang Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
7 de agosto de 2018
Conclusão Primária (Real)
31 de dezembro de 2018
Conclusão do estudo (Real)
31 de dezembro de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
23 de dezembro de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de dezembro de 2018
Primeira postagem (Real)
26 de dezembro de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de janeiro de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de janeiro de 2019
Última verificação
1 de dezembro de 2018
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- B-1807/483-303
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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