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Clinical Trials/NCT04737434
NCT04737434
Unknown
Not Applicable

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

Taipei Medical University1 site in 1 country100 target enrollmentJanuary 31, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress
Sponsor
Taipei Medical University
Enrollment
100
Locations
1
Primary Endpoint
sleep quality
Last Updated
5 years ago

Overview

Brief Summary

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worn from the afternoon of the first day to the afternoon of the fourth day, a total of three days, and the device is withdrawn at the end of the first stage The two groups exchanged, repeat the steps to complete the second stage, after the end of the post-test, the two groups plug in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.

Registry
clinicaltrials.gov
Start Date
January 31, 2021
End Date
January 25, 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tsai-Wei Huang

Associate Professor

Taipei Medical University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

sleep quality

Time Frame: 2 weeks

Questionnaire with PSQI(Pittsburgh Sleep Quality Index)

Secondary Outcomes

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

Study Sites (1)

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