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

NCT ID: NCT04737434

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2023-01-25

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worn from the afternoon of the first day to the afternoon of the fourth day, a total of three days, and the device is withdrawn at the end of the first stage The two groups exchanged, repeat the steps to complete the second stage, after the end of the post-test, the two groups plug in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

Conditions

Stress; Sleep Quality; Fatigue; Extremely Low Frequency Electromagnetic Field Device; Schumann Resonance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Extremely low frequency electromagnetic field device

with extremely low frequency electromagnetic wave

Group Type: EXPERIMENTAL

Extremely low frequency electromagnetic field device

Intervention Type: DEVICE

with extremely low frequency electromagnetic wave deliver or not to participants during sleep.

electromagnetic field with no wave

electromagnetic field with no wave

Group Type: PLACEBO_COMPARATOR

electromagnetic field with no wave

Intervention Type: DEVICE

electromagnetic field with no wave

Interventions

Extremely low frequency electromagnetic field device

with extremely low frequency electromagnetic wave deliver or not to participants during sleep.

Intervention Type: DEVICE

electromagnetic field with no wave

electromagnetic field with no wave

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Tsai-Wei Huang

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tsai-Wei Huang, PhD

Role: STUDY_CHAIR

Taipei Medical University

Locations

Taipei Medical University

Taipei County, , Taiwan

Countries

Taiwan

Other Identifiers

N202006078

Identifier Type: -

Identifier Source: org_study_id