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临床试验/CTRI/2024/04/065354
CTRI/2024/04/065354尚未招募3 期

Impact of breathing exercises and occupational health training on lung functions and psychological parameters in Polyvinylchloride factory workers: A Randomized controlled trial

Principal1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月16日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Change in lung function parameters.

研究概览

简要总结

Study title: Impact of breathing exercises and occupational health training on lung functions and psychological parameters in Polyvinyl Chloride factory workers: A Randomized controlled trial.

Rationale: Polyvinyl Chloride factory workers are exposed to various occupational hazards such as airborne pollutants and respiratory irritants. Investigating the effects of breathing exercises and occupational health training may reveal preventive measures that can mitigate the negative consequences of occupational exposures, ultimately reducing the risk of respiratory issues and psychological distress among PVC workers.

Aim: To assess and enhance the respiratory health and psychological well-being of PVC factory workers through the implementation of a comprehensive intervention program involving breathing exercises and occupational health training.

Primary objectives:

To design and implement a structured intervention program combining breathing exercises and occupational health training, tailored to the specific needs of PVC factory workers.

To evaluate changes in respiratory health due to the intervention of breathing exercises and occupational health training in PVC factory workers.

To evaluate changes in psychological parameters due to the intervention of breathing exercises and occupational health training in PVC factory workers.

Secondary objectives:

To explore correlations between changes in lung functions and psychological well-being.

To draw conclusions based on the study findings and provide recommendations for the development and implementation of future occupational health programs in PVC factories

Setting: Subjects will be recruited from PVC factory, Jhilmil Industrial Area, Delhi-95.

Study design: Prospective & intervention study

Time frame: April 2024 to August 2025

**Population/participants:**Healthy adult males in the age group of 20 – 40 years working in a PVC factory for at least 1 year.

Sample size: 60 (30 in each group)

Methods: All the participants included in this study will undergo complete physical, clinical and anthropometric assessment; prior to participation. After the clinical evaluation is complete, the study participants who fulfill the inclusion criteria and who sign the informed consent will be recruited for the study. Participants will be randomly assigned to either the intervention group or the control group by using a computer-generated random number sequence.

Intervention Group*: They will receive a structured intervention program consisting of breathing exercises and occupational health training. The intervention will be delivered for 3 months.*

Control Group*: They will not receive the intervention and will continue with their usual work routines.*

Both groups will be subjected to pre and post-intervention assessments of lung functions and psychological parameters.

Outcome measures:

Change in lung function parameters after 3 months.

Change in psychological parameters (Anxiety, Depression and Stress score) after 3 months.

 Statistical analysis:  Analysis will be done by the SPSS 20.0 statistic package. Within the group and between the group comparisons will be done by Repeated measure ANOVA followed by TUKEY’S test. P value of less than 0.05 will be considered significant.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
Male

入选标准

  • Healthy adult males in the age group of 20-40 years working in a PVC factory for at least 1 year will be recruited for the study.

排除标准

  • Participants with the following conditions will be excluded: 1 Any chronic illness.
  • 2 On any medication.
  • 3 Already performing breathing exercises or any other deep breathing exercises.

结局指标

主要结局

Change in lung function parameters.

时间窗: 3 months

次要结局

  • Change in psychological parameters (Anxiety, Depression and Stress score).(3 months)

研究者

发起方
Principal
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Kumar Vikram

University College of Medical Sciences & Guru Teg Bahadur Hospital

研究点 (1)

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