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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034181
Receipt No. R000038969
Scientific Title Examination of the utility of acupuncture and moxibustion treatment for physical and mental fatigue in workers
Date of disclosure of the study information 2018/09/25
Last modified on 2019/04/02

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Basic information
Public title Examination of the utility of acupuncture and moxibustion treatment for physical and mental fatigue in workers
Acronym Examination of the utility of acupuncture and moxibustion treatment for physical and mental fatigue in workers
Scientific Title Examination of the utility of acupuncture and moxibustion treatment for physical and mental fatigue in workers
Scientific Title:Acronym Examination of the utility of acupuncture and moxibustion treatment for physical and mental fatigue in workers
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Currently, health problems of workers are becoming a big social concern. From the past results of the labor health surveys and questionnaire surveys on fatigue, it can be suggested that many workers have feelings of anxiety about health due to fatigue of mind and body, accumulation of fatigue, stress due to work, and various subjective symptoms.
Fatigue may lead to a decrease in work efficiency, concentration, and memory ability, while to an increase in mistakes, plausibly causing lifestyle diseases, depression, death from overwork and the like. Effectiveness of acupuncture and moxibustion treatment in improving physical symptoms such as asthenopia, stiff neck/shoulder, general malaise frequently complained by workers with fatigue has also been reported. From the features of acupuncture and moxibustion therapy there is a possibility that it is effective against various symptoms such as fatigue and stress of mind and body, If we can prove the usefulness of acupuncture and moxibustion treatment, it will be meaningful from the viewpoint of health management. In this study, therefore, we examine the usefulness of acupuncture and moxibustion treatment for physical fatigue and mental fatigue in workers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual Analogue Scale
Key secondary outcomes GHQ-12
Salivary cortisol
Saliva amylase
Physical symptom score
SF-36 Standard Edition
WHO Health and Work Performance Questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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
Other
Interventions/Control_1 Acupuncture and Moxibustion
Interventions/Control_2 Press Needles
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
45 years-old >=
Gender Male and Female
Key inclusion criteria Person with physical fatigue and mental fatigue
Key exclusion criteria 1. Person who underwent consecutive treatments in a psychiatric clinic/hospital, took psychotropic drugs or had such medical history.
2. Person who had a change in living environment including working conditions and medication status or the past one month or less
3. Person with the medical abnormality that may cause fatigue
4. Person in whom a disease or abnormality was discovered and person who had a change in lifestyle or living environment during the study period
5. Female worker in the childcare period
6. Person who presents with a symptom of severe dysmenorrhea or premenstrual syndrome every month
7. Person with menopausal disorder
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tomomi
Middle name
Last name Sakai
Organization Tokyo Ariake University of Medical and Health Science
Division name Department of Acupuncture and Moxibustion
Zip code 135-0063
Address 2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
TEL +08-3-6703-7000
Email sakai@tau.ac.jp

Public contact
Name of contact person
1st name Arisa
Middle name
Last name Muko
Organization Tokyo Ariake University of Medical and Health Sciences Graduate school
Division name Doctor's Program of Health Sciences
Zip code 135-0063
Address 2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
TEL +08-3-6703-7000
Homepage URL
Email 5217002@tau.ac.jp

Sponsor
Institute Tokyo Ariake University of Medical and Health Sciences
Institute
Department

Funding Source
Organization Tokyo Ariake University of Medical and Health Sciences
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Ariake University of Medical and Health Sciences IRB
Address 2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
Tel +08-3-6703-7000
Email kida@tau.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
2018 Year 09 Month 25 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 Open public recruiting
Date of protocol fixation
2018 Year 07 Month 25 Day
Date of IRB
2018 Year 07 Month 26 Day
Anticipated trial start date
2018 Year 09 Month 25 Day
Last follow-up date
2020 Year 03 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 18 Day
Last modified on
2019 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038969

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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