UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033679 |
|---|---|
| Receipt number | R000038397 |
| Scientific Title | Relationship between fatigue evaluation method aimed at early detection of fatigue during nighttime work and dietary habits and trace element nutrition |
| Date of disclosure of the study information | 2018/08/08 |
| Last modified on | 2018/08/08 11:53:28 |
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Basic information
Public title
Relationship between fatigue evaluation method aimed at early detection of fatigue during nighttime work and dietary habits and trace element nutrition
Acronym
Nighttime work fatigue investigation with dietary survey and trace elements
Scientific Title
Relationship between fatigue evaluation method aimed at early detection of fatigue during nighttime work and dietary habits and trace element nutrition
Scientific Title:Acronym
Nighttime work fatigue investigation with dietary survey and trace elements
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims at objectively and easily evaluating the extent of fatigue in order to detect early fatigue at night and to clarify the relationship between dietary habits and trace element nutrition.
By investigating the degree of fatigue of nursing staff and nursing care staff during nighttime work considered to work while having fatigue, early detection of fatigue of night workers will be conducted. We aim to provide accident prevention and appropriate support for health maintenance / management in the future.
Basic objectives2
Others
Basic objectives -Others
Fatigue Investigation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Before nighttime work, During nighttime work, After nighttime work
1) Objective fatigue evaluation
1)-1 Flicker test
1)-2 Salivary Amylase
1)-3 Salivary Cortisol
Key secondary outcomes
2) Subjective fatigue evaluation
2)-1 Visual Analogue Scale (VAS)
2)-2 Subjective symptoms checkup
3) Trace elements in plasma
4) Fatigue Evaluation and dietary survey
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
For hospital staff, the hospital director is determined to be able to work at night, staff members who are in the shift to night work got cooperation, and informed consent was obtained. For university staff, the judgment result by the industrial physician shall be persons who are regarded as healthy in terms of employment: normal work, medical aspects: or equivalent. For students, the results of health checks shall comply with the judgment standards of staff.
Key exclusion criteria
none
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satomi, Kameo |
Organization
Gunma University
Division name
Department of Public Health, Graduate School of Medicine
Zip code
Address
Showa-machi 3-39-22, Maebashi, Gunma Prefecture, Japan
TEL
027-220-8013
skameo-t@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satomi, Kameo |
Organization
Gunma University
Division name
Department of Public Health, Graduate School of Medicine
Zip code
Address
Showa-machi 3-39-22, Maebashi, Gunma Prefecture, Japan
TEL
027-220-8013
Homepage URL
skameo-t@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 08 | Month | 08 | 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
| 2017 | Year | 04 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 08 | Month | 08 | Day |
Last modified on
| 2018 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038397
