- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05146596
The Effectiveness of Using Low-level Light Therapy to Treat Sleep and Psychological Symptoms Among Shift-work Nurses (t-PBM)
12. december 2021 opdateret af: Taipei Veterans General Hospital, Taiwan
The Effectiveness of Using Low-level Light Therapy to Treat Sleep and Psychological Symptoms Among Shift-work Nurses:A Randomized-controlled Trial
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
160
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Liao G Yung Hsuan
- Telefonnummer: 0910005317
- E-mail: yhliao3@vghtpe.gov.tw
Undersøgelse Kontakt Backup
- Navn: Liao General Y Hsuan
- Telefonnummer: 0910005317
- E-mail: yhliao3@vghtpe.gov.tw
Studiesteder
-
-
-
Taipei, Taiwan, 112
- Rekruttering
- Liao General Yung Hsuan
-
Kontakt:
- Liao General Y Hsuan, MD
- Telefonnummer: 0910005317
- E-mail: yhliao3@vghtpe.gov.tw
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
22 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: LLLT group
use low level light therapy,The Dr.Tai's energy cap
|
30 minutes each time, three times a week, a total of 12 times.
|
|
Ingen indgriben: control group
routine care.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
psychological symptoms
Tidsramme: 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.
|
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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
sleep symptoms
Tidsramme: 1 month,up to 4 weeks.Change from baseline ISI at 2,4 weeks.
|
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
|
1 month,up to 4 weeks.Change from baseline ISI at 2,4 weeks.
|
|
instrument:Heart rate variability(HRV)
Tidsramme: Measure three days a week, two time points (T0, T1) for each measurement, T0=baseline, and T1=after 30mins,24 times in both groups.
|
heart rhythm variability and autonomic nerves, so this study used this instrument as an objective data collection.
|
Measure three days a week, two time points (T0, T1) for each measurement, T0=baseline, and T1=after 30mins,24 times in both groups.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Liao General Y Hsuan, Taipei Veterans General Hospital, Taiwan
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juli 2021
Primær færdiggørelse (Forventet)
30. juni 2022
Studieafslutning (Forventet)
30. juni 2022
Datoer for studieregistrering
Først indsendt
29. juli 2021
Først indsendt, der opfyldte QC-kriterier
22. november 2021
Først opslået (Faktiske)
7. december 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. januar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. december 2021
Sidst verificeret
1. december 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2021-06-010C
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
The research is in progress and will not be published until it is completed.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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