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临床试验/NCT05146596
NCT05146596Unknown不适用

The Effectiveness of Using Low-level Light Therapy to Treat Sleep and Psychological Symptoms Among Shift-work Nurses:A Randomized-controlled Trial

Taipei Veterans General Hospital, Taiwan2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
试验地点
2
主要终点
psychological symptoms

研究概览

简要总结

The purpose of this study is to explore the treatment of Low Level Light Therapy(LLLT) mitigate possible insomnia and psychological symptoms, when nurses have taken shifts.The investigators hope that the goal of this interventional research is to improve sleep quality and psychological symptoms of shift nurses in order to promote health.

详细描述

Low-Level Light Therapy; LLLT is also called PhotoBioModulation; PBM, which is a new type of interventional therapy.LLLT applies low-level lasers or light-emitting diodes(LEDs) to the human body for treatment. The wavelength of irradiated light is between red light(630-700 nm) and near-infrared light(700nm-1,100nm), and leads to a positive biological effect. It is a safe, painless, non-invasive treatment method. When LLLT is applied to the brain, it can pass through the scalp, head bone and reach the brain, and then stimulating the photochemical reaction in the cells, This is called transcranial Low-Level Laser Therapy (t-LLLT) or transcranial Photobiomodulation(t-PBM). tLLLT has existed since 1967, and more than thousands of scientific studies have shown that photons can stimulate biological responses and promote the normal work of cells. t-LLLT can treat a variety of diseases, such as emotional symptoms, lower back pain, weight loss, skin anti-aging, wound healing, etc. There are no reports of side effects. The main mechanism is similar to the photosynthesis of plants. It absorbs light and produces chemical reactions, supports mitochondrial function, and significantly increases the production of ATP(the main carrier of energy in cells.)in the brain, so as to function work better and achieve self-repair. This research uses Dr. Tai's energy cap, the manufacturer is Topunion Globaltek Inc., which passed the certification of the Ministry of Health and Welfare(MOHW) for medical device in 2019. It has been modified to the second generation and is now on the market. It basically provides two kinds of red light (wavelength of 660nm) and near-infrared light(wavelength of 850nm), which is mainly used at home. The research intervention will be conducted for four weeks, pre-tests and post-tests will be conducted as indicators to evaluating sleep and psychological symptoms.

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
22 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Registered nurses who consciously have insomnia and ISI>=
  • People who have clear consciousness, can understand and agree to participate in this research.
  • Registered nurses who have been on shifts in the past six months.
  • Have the same type of shift within the four weeks.

排除标准

  • Those who have undergone head surgery.
  • Those who are pregnant.

结局指标

主要结局

psychological symptoms

时间窗: 1 month,up to 4 weeks.measure every 1 week.Change from baseline DASS-21 at 1,2,3,4 weeks, a total of five times.

use scale:Depression Anxiety Stress Scale-21(DASS-21)measure psychological symptoms.There are a total of 21 questions on the scale, each with a score of 3 and a score of 0 to 63. The higher score mean a worse outcome,mean psychological symptoms are severe.The higher the score the more severe the symptoms, the lower the score the more minor.

次要结局

  • instrument:Heart rate variability(HRV)(Measure three days a week, two time points (T0, T1) for each measurement, T0=baseline, and T1=after 30mins,24 times in both groups.)
  • sleep symptoms(1 month,up to 4 weeks.Change from baseline ISI at 2,4 weeks.)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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