Status Approved
First Submitted Date
2021/02/15
Registered Date
2021/02/23
Last Updated Date
2021/02/15
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005934 |
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Unique Protocol ID | 2-1040781-A-N-012020132HR |
Public/Brief Title | A Study of Work-related Musculoskeletal Disorders and Occupational Stress on Health-Related Quality of Life in Construction Workers |
Scientific Title | A Study of Work-related Musculoskeletal Disorders and Occupational Stress on Health-Related Quality of Life in Construction Workers |
Acronym | WMSDs |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 2-1040781-A-N-012020132HR |
Approval Date | 2020-12-17 |
Institutional Review Board Name | Sahmyook University institutional Review Board |
Institutional Review Board Address | 815, Hwarang-ro, Nowon-gu, Seoul |
Institutional Review Board Telephone | 02-3399-3906 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Soo Jeong |
Title | resercher |
Telephone | +82-2-3399-1634 |
Affiliation | National Health Insurance Service Ilsan Hospital |
Address | 100, Ilsan-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do, Republic of Korea |
Contact Person for Public Queries | |
Name | Byoung-Hee Lee |
Title | professor |
Telephone | +82-2-3399-1634 |
Affiliation | Sahmyook University |
Address | 815, Hwarang-ro, Nowon-gu, Seoul, Republic of Korea |
Contact Person for Updating Information | |
Name | hae ji Lee |
Title | resercher |
Telephone | +82-2-3399-1634 |
Affiliation | Sahmyook University |
Address | 815, Hwarang-ro, Nowon-gu, Seoul, Republic of Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Active, not recruiting | |
Date of First Enrollment | 2021-01-13 Actual | |
Target Number of Participant | 250 | |
Primary Completion Date | 2021-03-31 , Anticipated | |
Study Completion Date | 2021-04-30 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Beak du industrial technology | |
Recruitment Status | Active, not recruiting | |
Date of First Enrollment | 2021-01-13 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Sahmyook University |
Organization Type | University |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Sahmyook University |
Organization Type | University |
7. Study Summary
Lay Summary | The purpose of this study is to investigate the effects of work-related musculoskeletal disorders and occupational stress on health-related quality of life in construction workers. This will identify factors that affect the quality of life of construction workers and provide basic data for the prevention of work-related musculoskeletal disorders and the improvement of quality of life. Work-related musculoskeletal disorders are diseases and dysfunctions that occur in major joints due to the accumulation of damage to muscles and tissues due to repetitive work movements, such as the waist, neck, shoulders, arms, and wrists. It is a disease that is mainly displayed on the site. According to the occupational accident statistics of the Ministry of Employment and Labor (2019), the construction industry accounted for 12.6% (1,913 people), the manufacturing industry 36.8% (5,590 people), and the mining industry 15.5, based on the status of disease accidents by industry. It accounted for the second highest percentage after% (2,357 people). In addition, the number of people is increasing every year, such as an increase of 713 compared to 2018. In particular, when looking at the disaster situation of work-related musculoskeletal diseases in the 2018 occupational accident situation analysis report of the Ministry of Employment and Labor (2018), the construction industry accounted for 12.4% (833 people) and the manufacturing industry 42.2% (2836 people). It was reported that this was the second case after (person). Therefore, there is a need for continued attention to work-related musculoskeletal disorders in construction workers. Unlike the five-day work week that is carried out by a general company, the construction site changes fluidly according to the process conditions, and it is difficult to receive regular holidays and vacations. As a result, construction workers are exposed to the risk of serious accidents due to accumulated fatigue and stress, causing health problems to the individual's body, and work stress is also induced by extra working hours and high work intensity. There was a previous paper. Occupational stress and job requirements affect an individual worker's health level and health-related quality of life as a physical emotional adverse reaction that occurs when the employee's abilities, resources, and requirements do not match. It will be. That is, it suggests that occupational stress affects health-related quality of life. However, studies on occupational stress and health-related quality of life include production workers, firefighters, and security workers, general clerical workers, etc., research has been carried out mainly in various occupational fields, but there is almost no research targeting construction workers. It is the actual situation. Therefore, in this study, we would like to understand the degree of work-related musculoskeletal disorders and occupational stress for construction workers and identify the factors that affect health-related quality of life. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Case-only |
Time Perspective | Cross-sectional |
Target Number of Participant | 200 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label Construction workers |
Cohort/Group Description In this study, the general characteristics of the study subjects (eg. gender, job field, marital status, age, working period, working style, working hours per day, average monthly income) are created. After explaining this research and the survey method, creating a psychologically stable atmosphere, conducting a questionnaire, and asking the subjects who meet the selection criteria of the research subjects in advance for written consent, work relevance Conduct a questionnaire survey on work-related musculoskeletal disorders, occupational stress, and health-related quality of life. Work-related musculoskeletal diseases will be investigated using the musculoskeletal burden work harmful factors investigation instructions of the Korea Industrial Safety and Health Corporation. Occupational stress is investigated using the Korean Occupational Stress Scale (KOSS). Health-related quality of life is an assessment of life satisfaction and well-being using SF-36 and the 11-point scale. |
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Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Those who have been engaged in the construction industry for more than 3 months, understood the purpose of this study and agreed in writing to participate. |
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Sampling Method | Non-probablity sampling |
Condition(s)/Problem(s) |
Not Applicable-Quality of life
Work-related musculoskeletal disorder |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 20Year~65Year |
|
Description Those who have been engaged in the construction industry for more than 3 months, understood the purpose of this study and agreed in writing to participate. |
|
Exclusion Criteria |
Those who do not agree with clinical research |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Health-related quality of life (SF-36, life satisfaction and happiness using the 11-point scale) |
|
Timepoint | Creating a questionnaire after agreeing to the study |
|
Secondary Outcome(s) 1 | ||
Outcome | Work-related musculoskeletal disorder |
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Timepoint | Creating a questionnaire after agreeing to the study |
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Secondary Outcome(s) 2 | ||
Outcome | Occupational stress |
|
Timepoint | Creating a questionnaire after agreeing to the study |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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