The Effect of Neurofeedback-assisted Mindfulness Training on Stress Reduction in Employees With Emotional Labor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Mindfulness training with neurofeedback
mindfulness training with neurofeedback using mobile application instruction and review of the application will be provided
干预措施: stress management and meditation (Behavioral)
Mindfulness training
mindfulness training using mobile application instruction and review of the application will be provided
干预措施: stress management and meditation (Behavioral)
Self-care
结局指标
主要结局
Change from baseline Perceived Stress Scale (PSS) score at 4, 8 weeks
时间窗: Baseline and after 4, 8 weeks later
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.
次要结局
- Stroop test(Baseline and after 4, 8 weeks later)
- Change from baseline Korean abbreviation of Occupational Stress Scale (KOSS) score(Baseline and after 4, 8 weeks later)
- Change from baseline Brief resilience scale (BRS) score(Baseline and after 4, 8 weeks later)
- Heart Rate Variability (HRV)(Baseline and after 4, 8 weeks later)
- Change from baseline Korean Emotional Labor Assessment Tool score(Baseline and after 4, 8 weeks later)
- Change from baseline Patient Health Questionnaire 9 (PHQ-9) score(Baseline and after 4, 8 weeks later)
- Korean Mindful Attention Awareness Scale; K-MAAS(Baseline and after 4, 8 weeks later)
- Change from baseline Athens Insomnia Scale (AIS) score(Baseline and after 4, 8 weeks later)
- Quantitative electroencephalography (QEEG)(Baseline and after 4, 8 weeks later)