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临床试验/NCT03738202
NCT03738202已完成不适用

Multifaceted Intervention Package for Protection Against Cotton Dust Exposure Among Textile Workers - a Cluster Randomised Controlled Trial

Aga Khan University1 个研究点 分布在 1 个国家目标入组 2,031 人开始时间: 2019年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,031
试验地点
1
主要终点
Changes in cotton dust personal exposure levels expressed as mg/m3

研究概览

简要总结

Textile workers are exposed to various harmful substances during work, including cotton dust, which is the dust present in air during the handling or processing of cotton. Previous research found a link between cotton dust exposure and impaired respiratory health. This study will comprise of administration and workers' training regarding preventive measures for protection against respiratory illnesses. Workers will be provided free, disposable face masks and measures to reduce cotton dust exposure will be introduced at the textile mills. The study would then determine the effectiveness of this intervention on reduction in cotton dust levels in the mills, and improvement in respiratory health of workers. This study would help the cotton textile workers and managers reduce the health hazards of cotton dust exposure and also guide researchers from Pakistan and other low-resource countries towards developing relevant strategies for health protection of these workers.

详细描述

The textile, clothing and footwear sector provides employment to more than 60 million people worldwide, mostly in developing countries. Pakistan's textile industry accounts for 8.5% of the national GDP and employs around 40% of the industrial workforce. High burden of respiratory illnesses, including byssinosis and lung function decrements has been reported among cotton textile workers in developing countries and previous work undertaken by Dr Nafees found a high burden in Pakistan. Dr Nafees recently implemented an interventional study designed to improve workers' knowledge, attitude and practices and respiratory health, and reduce dust exposure at cotton textile mills through a multifaceted intervention (MultiTex pilot study). The preliminary findings from the pilot were helpful in improving the overall design and implementation of a larger and more definitive study (cluster randomised controlled trial). The aim of the trial would be to determine the effectiveness of a multifaceted interventional package for improvement in reducing dust levels at the cotton textile mills as well as improvement in respiratory health of textile workers.This study will add important context-specific knowledge regarding preventive strategies in cotton mills with policy implications for Pakistan and other developing countries.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Inclusion criteria for textile mills:
  • Mills from the formal sector will be included.
  • Mills which have either spinning or weaving sections, or both.
  • Mills that have at least 50-100 workers (primarily labourers/machine operators) in the spinning and weaving sections.
  • Mills with a more stable working population will be preferred.
  • Willingness of management to participate in planning and implementation of the study.
  • Inclusion criteria for textile workers:
  • Those ≥18 years and employed in the bale opening, blowing, carding, spinning, weaving and waste recycling sections (and related sub-sections).

排除标准

  • Textile workers from the wet-processing areas as well as support or administrative staff will be excluded.

结局指标

主要结局

Changes in cotton dust personal exposure levels expressed as mg/m3

时间窗: 24 months

Will be assessed through the use of IOM samplers

Changes in the prevalence of respiratory symptoms

时间窗: 24 months

Will be assessed through MRC respiratory questionnaire; symptoms include chest tightness, cough, phlegm, chronic bronchitis, wheezing and shortness of breath.

Changes in Forced Expiratory Volume in first second (FEV1) measured in in ml

时间窗: 24 months

Will be assessed through spirometry

次要结局

未报告次要终点

研究者

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

Asaad Ahmed Nafees

Assistant Professor

Aga Khan University

研究点 (1)

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