Occupational DiseasesNCT06961422
Association Between Occupational Fatigue and Mental Health Among Textile Shift Workers in Pakistan
An observational study of Occupational Diseases and Mental Disorders, run by Rawalpindi Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Occupational Diseases, Mental Disorders, Fatigue
- How many people
- 356 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Textile Industry Workers' Health Research Center
Karachi, Sindh, 74600
About this study
Official title: Impacts of Occupational Fatigue on the Mental Health of Shift Workers in Textile Industry of Karachi: A Cross-Sectional Study
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:
Read more
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.
Read the detailed description
Detailed Description
This study aims to assess the impact of occupational fatigue on the mental health of shift workers in the textile industry of Karachi. Given the growing concern about mental health issues in industries requiring extended hours and irregular shifts, this research seeks to identify how fatigue related to shift work affects the mental well-being of textile workers.
Study Design and Methodology
A cross-sectional study design will be employed to collect data from a sample of 356 shift workers in the textile sector. The sample will be selected using stratified random sampling to ensure a representative distribution across different demographic categories such as age, gender, and job type. Participants will be chosen from textile factories based in Karachi to provide a broader understanding of mental health issues in this sector.
Inclusion and Exclusion Criteria
The study will include workers who have been employed in the textile industry for at least six months. Workers with pre-existing mental health disorders, as identified by medical records, will be excluded to ensure the study focuses on occupational fatigue rather than underlying health conditions.
Data Collection Tools
Two standardized instruments will be used for data collection:
General Health Questionnaire (GHQ-28): This tool will assess the mental health status of participants, specifically focusing on symptoms such as anxiety, depression, and social dysfunction.
Multidimensional Fatigue Inventory (MFI-20): This will measure the severity of fatigue in the workers, evaluating both physical and mental fatigue, which may contribute to the workers' overall well-being.
Data will be gathered through face-to-face interviews and self-administered surveys. Informed consent will be obtained from each participant, ensuring that they understand the study's purpose and their right to confidentiality.
Statistical Analysis
The data will be analyzed using descriptive and inferential statistics. Descriptive statistics will summarize the demographic characteristics of the sample and the responses to the GHQ-28 and MFI-20. For inferential analysis, multiple regression analysis will be performed to explore the relationship between occupational fatigue and mental health, adjusting for potential confounders such as age, gender, and job type.
Ethical Considerations
The study has received ethical approval from the RSRS Ethical Review Board. All participants will provide written informed consent, and confidentiality will be maintained throughout the research process. The study will comply with ethical standards for research involving human subjects.
Expected Outcomes
The study is expected to find a significant correlation between occupational fatigue and poor mental health among shift workers. The findings could highlight the importance of fatigue management in improving the mental health of workers, suggesting the need for workplace interventions such as rest periods, psychological support programs, and changes in shift scheduling.
Limitations
This study is limited by its cross-sectional nature, which will only allow for the identification of associations rather than causal relationships. Additionally, the results may not be generalizable to workers in other industries or regions outside of Karachi.
- Conditions
- Occupational Diseases, Mental Disorders, Fatigue
- Keywords
- Occupational Fatigue, Shift Work, Mental Health, Textile Industry, Workplace Stress
- Medical subject headings
- Occupational Diseases, Mental Disorders, Fatigue, Psychological Well-Being, Occupational Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: April 2023 to June 2024
Secondary outcomes (1)
Assessment of Occupational Fatigue Using Multidimensional Fatigue Inventory (MFI-20)
This outcome measures occupational fatigue among shift workers using the Multidimensional Fatigue Inventory (MFI-20). The tool assesses five domains: general fatigue, physical fatigue, mental fatigue, reduced activity, and reduced motivation. Higher scores indicate greater fatigue levels.
Measured: April 2023 to June 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Apr 2023
- Primary completion15 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazeer Ahmed, Rawalpindi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961422
- Sponsor's protocol ID
- approval number: PH-46-46-21
- Status last verified
- May 2025
- First submitted
- 29 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data (IPD) for this study, including demographic details and responses from the GHQ-28 and MFI-20 assessments, will be shared upon request. The data will be anonymized and de-identified to protect participants' confidentiality. The sharing will be done with researchers who wish to further analyze the impact of occupational fatigue and mental health in shift workers in textile industries.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of Occupational Fatigue on the Mental Health of Shift Workers in Textile Industry of Karachi: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT06961422
- Acronym / sponsor ID
- approval number: PH-46-46-21
- Conditions
- Occupational Diseases, Mental Disorders, Fatigue
- Keywords
- Occupational Fatigue, Shift Work, Mental Health, Textile Industry, Workplace Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Rawalpindi Medical CollegeUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Detailed Description
This study aims to assess the impact of occupational fatigue on the mental health of shift workers in the textile industry of Karachi. Given the growing concern about mental health issues in industries requiring extended hours and irregular shifts, this research seeks to identify how fatigue related to shift work affects the mental well-being of textile workers.
Study Design and Methodology
A cross-sectional study design will be employed to collect data from a sample of 356 shift workers in the textile sector. The sample will be selected using stratified random sampling to ensure a representative distribution across different demographic categories such as age, gender, and job type. Participants will be chosen from textile factories based in Karachi to provide a broader understanding of mental health issues in this sector.
Inclusion and Exclusion Criteria
The study will include workers who have been employed in the textile industry for at least six months. Workers with pre-existing mental health disorders, as identified by medical records, will be excluded to ensure the study focuses on occupational fatigue rather than underlying health conditions.
Data Collection Tools
Two standardized instruments will be used for data collection:
General Health Questionnaire (GHQ-28): This tool will assess the mental health status of participants, specifically focusing on symptoms such as anxiety, depression, and social dysfunction.
Multidimensional Fatigue Inventory (MFI-20): This will measure the severity of fatigue in the workers, evaluating both physical and mental fatigue, which may contribute to the workers' overall well-being.
Data will be gathered through face-to-face interviews and self-administered surveys. Informed consent will be obtained from each participant, ensuring that they understand the study's purpose and their right to confidentiality.
Statistical Analysis
The data will be analyzed using descriptive and inferential statistics. Descriptive statistics will summarize the demographic characteristics of the sample and the responses to the GHQ-28 and MFI-20. For inferential analysis, multiple regression analysis will be performed to explore the relationship between occupational fatigue and mental health, adjusting for potential confounders such as age, gender, and job type.
Ethical Considerations
The study has received ethical approval from the RSRS Ethical Review Board. All participants will provide written informed consent, and confidentiality will be maintained throughout the research process. The study will comply with ethical standards for research involving human subjects.
Expected Outcomes
The study is expected to find a significant correlation between occupational fatigue and poor mental health among shift workers. The findings could highlight the importance of fatigue management in improving the mental health of workers, suggesting the need for workplace interventions such as rest periods, psychological support programs, and changes in shift scheduling.
Limitations
This study is limited by its cross-sectional nature, which will only allow for the identification of associations rather than causal relationships. Additionally, the results may not be generalizable to workers in other industries or regions outside of Karachi.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of Mental Health Status Using GHQ-28
Time frame: April 2023 to June 2024
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.
1 secondary outcome
Assessment of Occupational Fatigue Using Multidimensional Fatigue Inventory (MFI-20)
Time frame: April 2023 to June 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: Yes. The individual participant data (IPD) for this study, including demographic details and responses from the GHQ-28 and MFI-20 assessments, will be shared upon request. The data will be anonymized and de-identified to protect participants' confidentiality. The sharing will be done with researchers who wish to further analyze the impact of occupational fatigue and mental health in shift workers in textile industries.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Diseases and Mental Disorders, run by Rawalpindi Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Mental Health Status Using GHQ-28 (time frame: April 2023 to June 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.