Association Between Occupational Fatigue and Mental Health Among Textile Shift Workers in Pakistan

NCT06961422 | Completed

• 1 other identifier: approval number: PH-46-46-21
• Study Type: observational
• Target: 356
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary The goal of this observational study is to evaluate how occupational fatigue affects mental health outcomes in adult shift workers employed in the textile industry. The main questions it aims to answer are: What is the prevalence of mental health complaints among textile industry shift workers? How does occupational fatigue influence these mental health outcomes? Researchers will compare different levels of fatigue (based on MFI-20 scores) and their association with mental health status (based on GHQ-28 scores) to see if higher occupational fatigue is linked with poorer mental health. Participants will: Complete the Multidimensional Fatigue Inventory (MFI-20) to assess physical and mental fatigue. Complete the General Health Questionnaire (GHQ-28) to screen for psychological distress. Provide demographic and work-related information through a structured survey.

Conditions

Occupational Diseases; Mental Disorders; Fatigue

Keywords

Occupational Fatigue; Shift Work; Mental Health; Textile Industry; Workplace Stress

Outcome Measures

Primary Outcomes (1)

• Assessment of Mental Health Status Using GHQ-28

  This outcome measures the mental health status of shift workers using the General Health Questionnaire-28 (GHQ-28). The tool evaluates four domains: somatic symptoms, anxiety and insomnia, social dysfunction, and severe depression. Scores help identify probable mental health issues among workers.

  April 2023 to June 2024

Secondary Outcomes (1)

• Assessment of Occupational Fatigue Using Multidimensional Fatigue Inventory (MFI-20)

  April 2023 to June 2024

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population includes male and female shift workers employed in textile industries, representing various departments (production, packaging, quality control, etc.), selected through stratified random sampling to ensure representation across shifts and job roles.

You may qualify if:

• Workers employed in the textile industry for at least 6 months
• Involved in regular shift work (day/night rotation)
• Aged between 18 to 65 years
• Able to provide informed consent
• Willing to complete self-administered questionnaires

You may not qualify if:

• Diagnosed psychiatric disorders before employment
• Current use of psychotropic medications
• Diagnosed sleep disorders unrelated to occupational fatigue
• Severe physical illness or disability that may affect fatigue or mental health assessment

Sponsors & Collaborators

• Rawalpindi Medical College: lead

Study Sites (1)

Textile Industry Workers' Health Research Center

Karachi, Sindh, 74600, Pakistan

Location

MeSH Terms

Conditions

Occupational Diseases; Mental Disorders; Fatigue; Psychological Well-Being; Occupational Stress

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior; Stress, Psychological; Behavioral Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Final year medical student

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 8, 2025
• Study Start: April 1, 2023
• Primary Completion: June 15, 2024
• Study Completion: June 30, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The IPD and supporting information will be available for sharing starting from July 1025 and will remain available for 5 years (until January 2030).
• Access Criteria: Researchers who submit a formal request and agree to a data-sharing agreement will be granted access to the IPD. They will be able to access de-identified individual-level data and the associated analytic code. The data will be shared through a secure online portal.

Locations

PA (1)