NCT06479785

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
Last Updated

January 23, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

June 24, 2024

Last Update Submit

January 22, 2025

Conditions

Keywords

lung function, ergonomic hazards, marble factory workers

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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

    4 weeks

Secondary Outcomes (2)

  • Rapid Upper Limb Assessment (RULA)

    4 Weeks

  • Rapid Entire Body Assessment (REBA)

    4 Weeks

Study Arms (2)

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.

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.

Other: Educational Intervention Program for manual workers

Interventions

A detailed Educational Intervention Program for marble factory workers working on Machines.

Educational intervention program on machine workers

A detailed Educational Intervention Program for marble factory workers working manually.

Educational intervention program on manual workers

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult male marble factory workers,
  • Age 20-55years
  • Working for more than 1year
  • Working time(hours): minimum 06 hours daily

You may not qualify if:

  • Workers with pre-existing lung diseases
  • Workers with any other occupational hazard
  • Workers who are not willing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marble factories in Peshawar

Islamabad, AL, 44000, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 34868564BACKGROUND
  • Chen 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.

    PMID: 38429786BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Diseases

Study Officials

  • Suman Sheraz, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2024

First Posted

June 28, 2024

Study Start

July 15, 2024

Primary Completion

November 30, 2024

Study Completion

December 10, 2024

Last Updated

January 23, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations