Clinical trial NCT05146596: The Effectiveness of Using Low-level Light Therapy to Treat Sleep and Psychological Symptoms Among Shift-work Nurses
Official title: The Effectiveness of Using Low-level Light Therapy to Treat Sleep and Psychological Symptoms Among Shift-work Nurses：A Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shift Work Type Circadian Rhythm Sleep Disorder
Keywords: Anxiety
Depression
nurses
LLLT
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: National Yang Ming Chiao Tung University
First posted: 2021-12-07
Enrollment: 160
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1.Registered nurses who consciously have insomnia and ISI\>=9. 2. People who have clear consciousness, can understand and agree to participate in this research. 3. Registered nurses who have been on shifts in the past six months. 4. Have the same type of shift within the four weeks.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Registered nurses who consciously have insomnia and ISI\>=9.
2. People who have clear consciousness, can understand and agree to participate in this research.
3. Registered nurses who have been on shifts in the past six months.
4. Have the same type of shift within the four weeks.

Exclusion Criteria:

1. Those who have undergone head surgery.
2. Those who are pregnant.

Primary outcomes:
measure: psychological symptoms
timeFrame: 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.
Secondary outcomes:
measure: sleep symptoms
timeFrame: 1 month,up to 4 weeks.Change from baseline ISI at 2,4 weeks.
measure: instrument:Heart rate variability(HRV)
timeFrame: Measure three days a week, two time points (T0, T1) for each measurement, T0=baseline, and T1=after 30mins,24 times in both groups.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Liao General Yung Hsuan
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Liao General Y Hsuan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamblin MR. Photobiomodulation or low-level laser therapy. J Biophotonics. 2016 Dec;9(11-12):1122-1124. doi: 10.1002/jbio.201670113. No abstract available.