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临床试验/NCT07367646
NCT07367646尚未招募不适用

Development and Validation of a Multidimensional Screening Tool for Work-Related Musculoskeletal Disorders: A COSMIN-Guided Psychometric Study

Sahmyook University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年6月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
250
试验地点
1
主要终点
Structural Validity

研究概览

简要总结

The purpose of this study is to develop a multidimensional screening tool for Work-Related Musculoskeletal Disorders (WMSDs) and to evaluate its psychometric properties. The study involves a cross-sectional survey of approximately 250 workers in the bio-pharmaceutical industry to assess the tool's structural validity, internal consistency, construct validity, and measurement invariance following COSMIN guidelines.

详细描述

Work-related musculoskeletal disorders (WMSDs) are a major occupational health issue. While various screening tools exist, few comprehensively assess red flags (signs of serious pathology), yellow flags (psychosocial risk factors), and physical symptoms specifically for industrial workers. This study aims to address this gap by developing a new screening tool and validating its reliability and validity. The study design follows the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) checklist. The validation process involves a cross-sectional survey targeting 250 workers, including both office and production staff. The developed tool is designed to screen for serious medical conditions (Red flags) requiring referral, as well as to assess physical symptoms and psychosocial barriers (Yellow flags). Psychometric evaluation will specifically focus on the physical and psychosocial domains, as Red flags are typically binary screening items. Key psychometric properties to be evaluated include: 1. Structural Validity: Confirmatory Factor Analysis (CFA) will be conducted to verify the factor structure of the physical and psychosocial domains. 2. Internal Consistency: Cronbach's alpha coefficients will be calculated for these subscales. 3. Measurement Invariance: Multi-group CFA will be performed to ensure the tool functions equivalently across different job types (office vs. production). 4. Construct Validity: Correlations with established instruments (e.g., OSPRO-YF, FABQ, TSK) will be analyzed. The ultimate goal is to provide a practical and scientifically validated instrument for the early detection, triage, and management of WMSDs in workplace settings. 5. Cut-off Determination: ROC analysis will be conducted to establish optimal cut-off scores for identifying high-risk groups (Yellow flags), using established tools as a reference.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current regular employees working at the study site.
  • Adults aged 19 years or older who understand the study purpose and procedures and voluntarily agree to participate in writing.
  • Participants capable of reading, understanding, and self-responding to the questionnaire.
  • Individuals with musculoskeletal symptoms according to NIOSH standards: symptoms lasting more than one week OR recurring at least once a month in the past 12 months (symptoms include pain, aching, stiffness, burning sensation, tingling, or numbness).

排除标准

  • Individuals with cognitive or mental impairments that make it difficult to understand the study or complete the survey.
  • Individuals suspected of having a medical emergency or severe disease requiring immediate medical attention.
  • Individuals deemed unsuitable for participation by the researcher.

研究组 & 干预措施

Bio-pharmaceutical Industry Workers

Workers currently employed at Samsung Biologics, including both office and production staff, who meet the inclusion criteria for musculoskeletal symptoms.

干预措施: Survey Administration (Other)

结局指标

主要结局

Structural Validity

时间窗: Baseline

Evaluated using Confirmatory Factor Analysis (CFA). Model fit will be assessed based on stricter criteria: CFI ≥ 0.95, TLI ≥ 0.95, RMSEA ≤ 0.06, and SRMR ≤ 0.08 (Hu \& Bentler, 1999). If model fit is insufficient, modification indices (MI) will be used to adjust the model within theoretically justifiable limits.

次要结局

  • Internal Consistency(Baseline)
  • Measurement Invariance(Baseline)
  • Construct Validity(Baseline)
  • Cut-off Determination for Yellow Flags(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kibum Jung

Ph.D. Candidate

Sahmyook University

研究点 (1)

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