Respiratory DiseasesNCT06479785
Effects of an Educational Intervention Program on Marble Factory Workers
A study testing Educational Intervention Program for machine workers and Educational Intervention Program for manual workers in people with Respiratory Diseases, run by Riphah International University at 1 site in Pakistan.
Trial summary
Marble cutting exposes workers to dust, increasing risk of lung diseases like asthma, COPD, silicosis, and asbestosis. Many marble cutters in rural areas lack awareness of these risks and work without proper protection. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men only
- Conditions the study is for
- Respiratory Diseases
- What is being tested?
- Educational Intervention Program for machine workers and Educational Intervention Program for manual workers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2024to 10 Dec 2024
- Phase
- Interventional
- 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 20 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Adult male marble factory workers,
- Age 20-55years
- Working for more than 1year
- Working time(hours): minimum 06 hours daily
Who cannot join
- Workers with pre-existing lung diseases
- Workers with any other occupational hazard
- Workers who are not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Educational Intervention Program on Lung Function and Ergonomic Hazards Among Marble Factory Workers: Quasi-experimental Study
Marble cutting exposes workers to dust, increasing risk of lung diseases like asthma, COPD, silicosis, and asbestosis. Many marble cutters in rural areas lack awareness of these risks and work without proper protection. Khyber Pakhtunkhwa has over 4000 marble factories employing over a million laborers, mostly unskilled and vulnerable. Workers face health risks from heavy lifting, poor posture, and respirable dust. Ergonomic disorders are also common due to poorly designed workstations, repetitive motions, and straining postures. Musculoskeletal Symptoms (MSS) can progress into Musculoskeletal Disorders (MSDs), affecting worker well-being and productivity. Findings can inform targeted educational programs and interventions to improve respiratory health and reduce ergonomic risks in the marble industry.
Read the detailed description
Occupational hazards, such as dust exposure during marble cutting, can significantly increase the risk of lung diseases in workers. This includes common ailments such as asthma and Chronic Obstructive Pulmonary Disease (COPD), as well as more serious conditions such as silicosis and asbestosis. Unfortunately, many marble cutters from rural areas may not be aware of these health risks, which can lead to them working without proper protection. Heavy load lifting, poor work posture, and the production of respirable dust in marble factories contribute to the health risks faced by these workers. Just like dust exposure during marble cutting can harm a worker's lungs, similarly, working in this industry carries a high risk of ergonomic disorders. According to the Bureau of Labor Statistics, ergonomic risk factors are responsible for 35% of workplace injuries in 2021, resulting in MSDs. An extensive amount of research has been conducted globally; however, limited literature exists on this particular topic in Khyber Pakhtunkhwa, specifically in Peshawar. The findings of the study can help inform the development and implementation of targeted educational programs and interventions aimed at improving respiratory health and reducing ergonomic risks in the marble industry.
- Conditions
- Respiratory Diseases
- Being tested
- Educational Intervention Program for machine workers, Educational Intervention Program for manual workers
- Keywords
- lung function, ergonomic hazards, marble factory workers
- Medical subject headings
- Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Intervention Program for machine workersOther
A detailed Educational Intervention Program for marble factory workers working on Machines.
Educational Intervention Program for manual workersOther
A detailed Educational Intervention Program for marble factory workers working manually.
| Study group | Role | What they receive |
|---|---|---|
| Educational intervention program on machine workers | Experimental | Use proper protective gears like mask, glasses, glove and proper foot wear. Maintain proper posture. Avoid repetitive movement. Receives: Other: Educational Intervention Program for machine workers |
| Educational intervention program on manual workers | Experimental | Use proper protective gears like mask, glasses, glove and proper foot wear. Maintain proper posture during heavy load lifting. Take breaks during prolong period of work. Receives: Other: Educational Intervention Program for manual workers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak expiratory flow rate (PEFR)
Peak expiratory flow rate (PEFR) Peak expiratory flow rate (PEFR) measured through digital spirometer. Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings.
Measured: 4 weeks
Forced vital capacity (FVC)
Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal.
Measured: 4 weeks
Forced expiratory volume in 1sec (FEV1)
Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal
Measured: 4 weeks
Secondary outcomes (2)
Rapid Upper Limb Assessment (RULA)
RULA evaluates the exposure to posture and force/external load as well as repeated and static posture effects.
Measured: 4 Weeks
Rapid Entire Body Assessment (REBA)
REBA evaluates the exposure to posture and force/external load as well as repeated and static posture effects. The REBA has two additional assessment factors of coupling and dynamic loading effects, compared to the RULA
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start15 Jul 2024
- Primary completion30 Nov 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suman Sheraz, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479785
- Sponsor's protocol ID
- Waseem Ullah
- Status last verified
- Jan 2025
- First submitted
- 24 Jun 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Butt IM, Mustafa T, Rauf S, Razzaq A, Anwer J. Pulmonary function parameters among marble industry workers in Lahore, Pakistan. F1000Res. 2021 Sep 17;10:938. doi: 10.12688/f1000research.52749.1. eCollection 2021.
PubMed 34868564Chen CH, Tsai PJ, Chang WW, Chen CY, Chen CY, Yates D, Guo YL. Dose-response relationship between lung function and chest imaging response to silica exposures in artificial stone manufacturing workers. Environ Health. 2024 Mar 2;23(1):25. doi: 10.1186/s12940-024-01067-1.
PubMed 38429786
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Educational Intervention Program on Lung Function and Ergonomic Hazards Among Marble Factory Workers: Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT06479785
- Acronym / sponsor ID
- Waseem Ullah
- Conditions
- Respiratory Diseases
- Keywords
- lung function, ergonomic hazards, marble factory workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 28 Jun 2024 (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.
Marble cutting exposes workers to dust, increasing risk of lung diseases like asthma, COPD, silicosis, and asbestosis. Many marble cutters in rural areas lack awareness of these risks and work without proper protection. Khyber Pakhtunkhwa has over 4000 marble factories employing over a million laborers, mostly unskilled and vulnerable. Workers face health risks from heavy lifting, poor posture, and respirable dust. Ergonomic disorders are also common due to poorly designed workstations, repetitive motions, and straining postures. Musculoskeletal Symptoms (MSS) can progress into Musculoskeletal Disorders (MSDs), affecting worker well-being and productivity. Findings can inform targeted educational programs and interventions to improve respiratory health and reduce ergonomic risks in the marble industry.
Detailed description
Occupational hazards, such as dust exposure during marble cutting, can significantly increase the risk of lung diseases in workers. This includes common ailments such as asthma and Chronic Obstructive Pulmonary Disease (COPD), as well as more serious conditions such as silicosis and asbestosis. Unfortunately, many marble cutters from rural areas may not be aware of these health risks, which can lead to them working without proper protection. Heavy load lifting, poor work posture, and the production of respirable dust in marble factories contribute to the health risks faced by these workers. Just like dust exposure during marble cutting can harm a worker's lungs, similarly, working in this industry carries a high risk of ergonomic disorders. According to the Bureau of Labor Statistics, ergonomic risk factors are responsible for 35% of workplace injuries in 2021, resulting in MSDs. An extensive amount of research has been conducted globally; however, limited literature exists on this particular topic in Khyber Pakhtunkhwa, specifically in Peshawar. The findings of the study can help inform the development and implementation of targeted educational programs and interventions aimed at improving respiratory health and reducing ergonomic risks in the marble industry.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational intervention program on machine workers | Experimental | Other: Educational Intervention Program for machine workersUse proper protective gears like mask, glasses, glove and proper foot wear. Maintain proper posture. Avoid repetitive movement. |
| Educational intervention program on manual workers | Experimental | Other: Educational Intervention Program for manual workersUse proper protective gears like mask, glasses, glove and proper foot wear. Maintain proper posture during heavy load lifting. Take breaks during prolong period of work. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult male marble factory workers,
- Age 20-55years
- Working for more than 1year
- Working time(hours): minimum 06 hours daily
Key exclusion criteria (3 listed)
- Workers with pre-existing lung diseases
- Workers with any other occupational hazard
- Workers who are not willing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Intervention Program for machine workersA detailed Educational Intervention Program for marble factory workers working on Machines. | Other | Educational intervention program on machine workers |
| Educational Intervention Program for manual workersA detailed Educational Intervention Program for marble factory workers working manually. | Other | Educational intervention program on manual workers |
Primary outcome
Peak expiratory flow rate (PEFR)
Time frame: 4 weeks
Peak expiratory flow rate (PEFR) Peak expiratory flow rate (PEFR) measured through digital spirometer. Peak Expiratory Flow Rate (PEFR) measured through digital spirometer. Three zones of measurement are commonly used to interpret peak flow rates. Normal value of PEFR is (80-100%). Green zone indicates 80 to 100 percent of the usual or normal peak flow reading, yellow zone indicates 50 to 79 percent of the usual or normal peak flow readings, and red zone indicates less than 50 percent of the usual or normal peak flow readings.
Forced vital capacity (FVC)
Time frame: 4 weeks
Forced vital capacity (FVC) measured through digital spirometer. If the value of FVC is within 80% of the reference value, the results are considered normal.
Forced expiratory volume in 1sec (FEV1)
Time frame: 4 weeks
Forced expiratory volume in 1sec (FEV1) measured through digital spirometer. If the value of FEV1 is within 80% of the reference value, the results are considered normal
2 secondary outcomes
Rapid Upper Limb Assessment (RULA)
Time frame: 4 Weeks
Rapid Entire Body Assessment (REBA)
Time frame: 4 Weeks
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 23 Jan 2025.
- Background: PubMed 34868564Butt IM, Mustafa T, Rauf S, Razzaq A, Anwer J. Pulmonary function parameters among marble industry workers in Lahore, Pakistan. F1000Res. 2021 Sep 17;10:938. doi: 10.12688/f1000research.52749.1. eCollection 2021.
- Background: PubMed 38429786Chen CH, Tsai PJ, Chang WW, Chen CY, Chen CY, Yates D, Guo YL. Dose-response relationship between lung function and chest imaging response to silica exposures in artificial stone manufacturing workers. Environ Health. 2024 Mar 2;23(1):25. doi: 10.1186/s12940-024-01067-1.
- Individual participant dataSharing planned: No
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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.
Suman Sheraz, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention Program for machine workers and Educational Intervention Program for manual workers in people with Respiratory Diseases, run by Riphah International University 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 4 inclusion and 3 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 23 Jan 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?
Peak expiratory flow rate (PEFR) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06479785, which also lists 2 linked publications.
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 23 Jan 2025.