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The Effectiveness of Using Low-level Light Therapy to Treat Sleep and Psychological Symptoms Among Shift-work Nurses (t-PBM)

Primary Purpose

Shift Work Type Circadian Rhythm Sleep Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
use low level light therapy,The Dr.Tai's energy cap
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Shift Work Type Circadian Rhythm Sleep Disorder focused on measuring Anxiety, Depression, nurses, LLLT

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Liao General Yung HsuanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

LLLT group

control group

Arm Description

use low level light therapy,The Dr.Tai's energy cap

routine care.

Outcomes

Primary Outcome Measures

psychological symptoms
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.

Secondary Outcome Measures

sleep symptoms
use scale:Insomnia Severity Index(ISI) measure sleep symptoms.There are a total of 7 questions on the scale, each with a score of 4 and a score of 0 to 28. The higher score mean a worse outcome,mean sleep symptoms are severe.The study measure use ISI scale every 2 weeks
instrument:Heart rate variability(HRV)
heart rhythm variability and autonomic nerves, so this study used this instrument as an objective data collection.

Full Information

First Posted
July 29, 2021
Last Updated
December 12, 2021
Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
National Yang Ming University
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1. Study Identification

Unique Protocol Identification Number
NCT05146596
Brief Title
The Effectiveness of Using Low-level Light Therapy to Treat Sleep and Psychological Symptoms Among Shift-work Nurses
Acronym
t-PBM
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
National Yang Ming University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shift Work Type Circadian Rhythm Sleep Disorder
Keywords
Anxiety, Depression, nurses, LLLT

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LLLT group
Arm Type
Experimental
Arm Description
use low level light therapy,The Dr.Tai's energy cap
Arm Title
control group
Arm Type
No Intervention
Arm Description
routine care.
Intervention Type
Device
Intervention Name(s)
use low level light therapy,The Dr.Tai's energy cap
Intervention Description
30 minutes each time, three times a week, a total of 12 times.
Primary Outcome Measure Information:
Title
psychological symptoms
Description
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.
Time Frame
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 Outcome Measure Information:
Title
sleep symptoms
Description
use scale:Insomnia Severity Index(ISI) measure sleep symptoms.There are a total of 7 questions on the scale, each with a score of 4 and a score of 0 to 28. The higher score mean a worse outcome,mean sleep symptoms are severe.The study measure use ISI scale every 2 weeks
Time Frame
1 month,up to 4 weeks.Change from baseline ISI at 2,4 weeks.
Title
instrument:Heart rate variability(HRV)
Description
heart rhythm variability and autonomic nerves, so this study used this instrument as an objective data collection.
Time Frame
Measure three days a week, two time points (T0, T1) for each measurement, T0=baseline, and T1=after 30mins,24 times in both groups.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Registered nurses who consciously have insomnia and ISI>=9. 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. Exclusion Criteria: Those who have undergone head surgery. Those who are pregnant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liao G Yung Hsuan
Phone
0910005317
Email
yhliao3@vghtpe.gov.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Liao General Y Hsuan
Phone
0910005317
Email
yhliao3@vghtpe.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liao General Y Hsuan
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liao General Yung Hsuan
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liao General Y Hsuan, MD
Phone
0910005317
Email
yhliao3@vghtpe.gov.tw

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The research is in progress and will not be published until it is completed.
Citations:
PubMed Identifier
27973730
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.
Results Reference
result

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The Effectiveness of Using Low-level Light Therapy to Treat Sleep and Psychological Symptoms Among Shift-work Nurses

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