UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059080 |
|---|---|
| Receipt number | R000067579 |
| Scientific Title | Effects of Combined Power Napping and Acupuncture on Fatigue among Female Workers: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/09/14 |
| Last modified on | 2025/09/13 11:38:53 |
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Basic information
Public title
The Power Nap and Acupuncture Study for Reducing Fatigue in Working Women
Acronym
Women's fatigue and Acupuncture with power nap
Scientific Title
Effects of Combined Power Napping and Acupuncture on Fatigue among Female Workers: A Randomized Controlled Trial
Scientific Title:Acronym
Napping and Acupuncture Randomized Controlled Trial
Region
| Japan |
Condition
Condition
fatigue
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to investigate, in female workers, the additive effects of acupuncture on fatigue levels and work performance when combined with power napping, which serves as a standard intervention for fatigue and sleepiness, using a randomized controlled trial design.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue levels and alertness will be compared between groups at baseline, after one month of intervention, and at the end of the two-month intervention period using the JNIOSH Fatigue Checker.
Key secondary outcomes
Presenteeism will be compared between groups at baseline, after one month of intervention, and at the end of the two-month intervention period using the short version of the WHO-HPQ.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Power naps will be conducted twice a week for 20 minutes each time between 12:00 and 14:30, while acupuncture needles are retained, for a total of 16 sessions over 8 weeks.
Interventions/Control_2
Power naps will be conducted twice a week for 20 minutes each time between 12:00 and 14:30, for a total of 16 sessions over 8 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
The study will include female workers aged from20 to 60 years who experience physical and mental fatigue, such as work-related tiredness, decreased concentration, and reduced motivation.
Key exclusion criteria
Participants who are undergoing treatment for depression.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shunji |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kansai University of Health Sciences
Division name
Graduate School
Zip code
5900482
Address
2-11-1 Wakaba, Kumatori-cho, Sennan-gun, Osaka, Japan
TEL
0724538409
sakaguti@kansai.ac.jp
Public contact
Name of contact person
| 1st name | Shunji |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kansai University of Health Sciences
Division name
Graduate School
Zip code
5900482
Address
2-11-1 Wakaba, Kumatori-cho, Sennan-gun, Osaka, Japan
TEL
072-453-8409
Homepage URL
sakaguti@kansai.ac.jp
Sponsor or person
Institute
Kansai University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Kansai University of Health Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai University of Health Sciences
Address
2-11-1 Wakaba, Kumatori-cho, Sennan-gun, Osaka, Japan
Tel
0724538409
sakaguti@kansai.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 13 | Day |
Last modified on
| 2025 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067579
