The Effect of Neurofeedback-assisted Mindfulness Training in Employees With Emotional Labor
9 de enero de 2019 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
96
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Gyeonggi-do
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Seongnam, Gyeonggi-do, Corea, república de, 13605
- Seoul National University Bundang Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
19 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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 activo: 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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Sin intervención: Self-care
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline Korean Emotional Labor Assessment Tool score
Periodo de tiempo: Baseline and after 4, 8 weeks later
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline and after 4, 8 weeks later
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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
Periodo de tiempo: Baseline and after 4, 8 weeks later
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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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jeong Hyun Kim, MD, Ph.D, Seoul National Univerysity Bundang Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
7 de agosto de 2018
Finalización primaria (Actual)
31 de diciembre de 2018
Finalización del estudio (Actual)
31 de diciembre de 2018
Fechas de registro del estudio
Enviado por primera vez
23 de diciembre de 2018
Primero enviado que cumplió con los criterios de control de calidad
23 de diciembre de 2018
Publicado por primera vez (Actual)
26 de diciembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de enero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
9 de enero de 2019
Última verificación
1 de diciembre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- B-1807/483-303
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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