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临床试验/NCT04737434
NCT04737434Unknown不适用

The Effect of Extremely Low Frequency Electromagnetic Field Device Improving Sleep Quality and Stress

Taipei Medical University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月31日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
sleep quality

研究概览

简要总结

The purpose of this study is to explore the effects of extremely low frequency electromagnetic waves on improving stress and sleep quality. Experimental studies, pre- and post-test double-blind crossover tests are adopted. The selected subjects include: patients in the sleep center of the Taipei Medical University Hospital and the Department of Nursing and Bachelor of Taipei Medical University There are about 100 students in the post-nursing department. They are randomly assigned to groups A and B using a computer. The experiment period is two weeks. The two groups will take a pre-questionnaire test in the afternoon of the first day of the experiment and wear wearable bracelets. Group A first After getting the device with low-frequency electromagnetic field, group B first got the device without low-frequency electromagnetic field. The appearance of the two is the same. The bracelet is worn from the afternoon of the first day to the afternoon of the fourth day, a total of three days, and the device is withdrawn at the end of the first stage The two groups exchanged, repeat the steps to complete the second stage, after the end of the post-test, the two groups plug in the device half an hour before going to bed every day, and put it on the bedside table about 20cm away from the head, and then turn off the device after getting up. The research tools are basic attribute questionnaires, sleep quality scales, sleep diaries, smart care VIP bracelets, and EEG. Among them, the wearable bracelet can monitor the stress index, fatigue index, calories burned, and walking steps. Then SPSS 22.0 software is used for data file building and statistical analysis. The data is analyzed by descriptive statistics and inferential statistics. The expected result is that the experimental group and the control group have significant differences in reducing stress and improving sleep quality, which can relieve stress and improve sleep quality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • under 20 years old,great mental health,BMI is between 18.5~24(normal range).

排除标准

  • Cognitive disturbance, confusion, pregnancy, alcohol and caffeine addiction.

结局指标

主要结局

sleep quality

时间窗: 2 weeks

Questionnaire with PSQI(Pittsburgh Sleep Quality Index)

次要结局

  • stress level(2 weeks)
  • HRV(Heart rate variability) level(2 weeks)
  • EEG (Electroencephalography) power(2 weeks)
  • fatigue levels(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tsai-Wei Huang

Associate Professor

Taipei Medical University

研究点 (2)

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