The Effectiveness of Using Low-level Light Therapy to Treat Sleep and Psychological Symptoms Among Shift-work Nurses (t-PBM)
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|ClinicalTrials.gov Identifier: NCT05146596|
Recruitment Status : Recruiting
First Posted : December 7, 2021
Last Update Posted : January 3, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Shift Work Type Circadian Rhythm Sleep Disorder||Device: use low level light therapy,The Dr.Tai's energy cap||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effectiveness of Using Low-level Light Therapy to Treat Sleep and Psychological Symptoms Among Shift-work Nurses：A Randomized-controlled Trial|
|Actual Study Start Date :||July 1, 2021|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: LLLT group
use low level light therapy,The Dr.Tai's energy cap
Device: use low level light therapy,The Dr.Tai's energy cap
30 minutes each time, three times a week, a total of 12 times.
No Intervention: control group
- psychological symptoms [ 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. ]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.
- sleep symptoms [ Time Frame: 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
- instrument:Heart rate variability(HRV) [ 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. ]heart rhythm variability and autonomic nerves, so this study used this instrument as an objective data collection.
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|Ages Eligible for Study:||22 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- Those who have undergone head surgery.
- Those who are pregnant.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05146596
|Contact: Liao G Yung Hsuanemail@example.com|
|Contact: Liao General Y Hsuanfirstname.lastname@example.org|
|Liao General Yung Hsuan||Recruiting|
|Taipei, Taiwan, 112|
|Contact: Liao General Y Hsuan, MD 0910005317 email@example.com|
|Principal Investigator:||Liao General Y Hsuan||Taipei Veterans General Hospital, Taiwan|
|Responsible Party:||Taipei Veterans General Hospital, Taiwan|
|Other Study ID Numbers:||
|First Posted:||December 7, 2021 Key Record Dates|
|Last Update Posted:||January 3, 2022|
|Last Verified:||December 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Plan Description:||The research is in progress and will not be published until it is completed.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Nervous System Diseases