NCT05146596

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

January 3, 2022

Status Verified

December 1, 2021

Enrollment Period

12 months

First QC Date

July 29, 2021

Last Update Submit

December 12, 2021

Conditions

Keywords

AnxietyDepressionnursesLLLT

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 (2)

  • sleep symptoms

    1 month,up to 4 weeks.Change from baseline ISI at 2,4 weeks.

  • 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.

Study Arms (2)

LLLT group

EXPERIMENTAL

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

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

control group

NO INTERVENTION

routine care.

Interventions

30 minutes each time, three times a week, a total of 12 times.

LLLT group

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liao General Yung Hsuan

Taipei, 112, Taiwan

RECRUITING

Related Publications (2)

  • 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.

  • Liao YH, Tai CJ, Ming JL, Lin LH, Chien LY. The Effectiveness of Low-Level LED Light Therapy for Sleep Problems, Psychological Symptoms, and Heart Rate Variability in Shift-Work Nurses: A Randomized Controlled Trial. J Nurs Manag. 2025 Jun 17;2025:6478834. doi: 10.1155/jonm/6478834. eCollection 2025.

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Liao General Y Hsuan

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Liao G Yung Hsuan

CONTACT

Liao General Y Hsuan

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2021

First Posted

December 7, 2021

Study Start

July 1, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

January 3, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

The research is in progress and will not be published until it is completed.

Locations