UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058838 |
|---|---|
| Receipt number | R000067275 |
| Scientific Title | Association of Effort-Reward Imbalance with Fingernail Cortisol Levels in Apparel Manufacturing Workers |
| Date of disclosure of the study information | 2025/08/31 |
| Last modified on | 2025/08/19 14:58:00 |
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Basic information
Public title
A study on the relationship between job stress and hormone levels in fingernails of workers
Acronym
Nail cortisol x Stress
Scientific Title
Association of Effort-Reward Imbalance with Fingernail Cortisol Levels in Apparel Manufacturing Workers
Scientific Title:Acronym
ERI-Nail Study
Region
| Japan |
Condition
Condition
Occupational stress
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to examine the association between effort and reward scores based on the Effort-Reward Imbalance (ERI) model and fingernail cortisol concentrations among apparel manufacturing workers. By using fingernail cortisol as a physiological biomarker, the study aims to explore the potential of assessing chronic stress accumulation and to evaluate its relationship with subjective stress indicators.
Basic objectives2
Others
Basic objectives -Others
To examine the association between work-related stress assessed using the Effort-Reward Imbalance model and cortisol levels in fingernails, in order to evaluate the potential of nail cortisol as a biomarker for psychosocial stress.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Fingernail cortisol concentration (measured at Time1 concurrently with the questionnaire survey and at Time2 approximately 3-4 months after the survey)
Key secondary outcomes
Effort score (measured using the ERI questionnaire at Time1)
Reward score (measured using the ERI questionnaire at Time1)
Effort-Reward ratio (calculated from the ERI questionnaire at Time1)
Association with background factors such as gender, age, job type, and working hours
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
Workers engaged in apparel manufacturing (including full-time, contract, part-time, and temporary employees)
Aged 20 years or older
Able to read and write in Japanese, and consented to participate in the questionnaire survey and provide fingernail samples
Provided written informed consent after receiving an explanation of the study purpose and procedures
Key exclusion criteria
Individuals with nail disorders or abnormalities
e.g., participants with conditions such as onychomycosis or other nail abnormalities that may affect cortisol measurement.
Individuals with artificially altered nails
Participants who had artificial nail treatments such as nail art, gel nails, or sculptured nails.
Individuals who had recently clipped their nails (within the past month) and were unable to provide a sufficient nail sample
Participants whose nail length was insufficient for hormone analysis.
Individuals with incomplete responses to the questionnaire
Participants with missing data that would hinder the analysis of the ERI scale or background variables.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Nakata |
Organization
Department of Preventive Medicine and Community, University of Occupational and Environmental Health
Division name
Public Health
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu-shi, Fukuoka, Japan
TEL
093-603-1611
nakataa@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Mikiko |
| Middle name | |
| Last name | Kawasaki |
Organization
Japanese Red Cross Kyushu International College of Nursing, Fukuoka, Japan
Division name
Department of Nursing, School of Nursing
Zip code
811-4157
Address
1-1, Asty 1-chome, Munakata-shi, Fukuoka, Japan
TEL
0940-35-7001
Homepage URL
m-kawasaki@jrckicn.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Japan Fullhap Research Grant
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfar
Address
4-1-26 Akasaka, Minato-ku, Tokyo, Japan
Tel
03-5574-3900
rinri-tky@ihwg.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 | 08 | Month | 31 | 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
136
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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study targeting workers in the apparel manufacturing industry. The aim is to examine the association between occupational stress - specifically effort-reward imbalance - and cortisol levels measured in fingernail samples. No interventions are conducted. Data were collected via self-administered questionnaires and biological sampling (fingernails), focusing on psychosocial work environment and physiological stress indicators.
Management information
Registered date
| 2025 | Year | 08 | Month | 19 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067275
