| CTRI Number |
CTRI/2025/08/093743 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
An educational program to improve lung health and reduce respiratory problems among factory workers |
|
Scientific Title of Study
|
A study of Effectiveness of interventional package of knowledge and practice regarding prevention and management of selected respiratory disease and its contributing factors among factory workers |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRIYANKA MASIH |
| Designation |
Associate Professor |
| Affiliation |
teerthanker mahaveer college of nursingTeerthanker Mahaveer University |
| Address |
Department of medical surgical nursing room no-201,Teerthanker Mahaveer College of Nursing Teerthanker Mahaveer University Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9557297187 |
| Fax |
|
| Email |
priyanka.nursing@tmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
prof Dr M Jasline |
| Designation |
principal |
| Affiliation |
teerthanker mahaveer college of nursingTeerthanker Mahaveer University |
| Address |
Department of medical surgical nursing room no-102,Teerthanker Mahaveer College of Nursing Teerthanker Mahaveer University Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8279816167 |
| Fax |
|
| Email |
drjaslinejohn.msn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
prof Dr M Jasline |
| Designation |
principal |
| Affiliation |
teerthanker mahaveer college of nursingTeerthanker Mahaveer University |
| Address |
Department of medical surgical nursing room no-102,Teerthanker Mahaveer College of Nursing Teerthanker Mahaveer University Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8279816167 |
| Fax |
|
| Email |
drjaslinejohn.msn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer College of Nursing ,uttar pradesh 244001 |
|
|
Primary Sponsor
|
| Name |
Priyanka Masih |
| Address |
Department of Medical Surgical Nursing room no -201 teerthanker mahaveer college of nursing Teerthankaer Mahaveer University
Uttar Pradesh Moradabad Pincode 244001 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vishal Swaroop |
Lata Enterprises |
OFF Khasra no 1194 1196 1197 Village Manoharpur underpass delhi road moradabad Uttar Pradesh Pincode 244001
Moradabad
UTTAR PRADESH |
9412246013
info@christmasgiftsdecoration.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| lata enterprises NOC |
Approved |
| Teerthanker Mahaveer Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
occupational exposure related respiratory conditions |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Interventional Package of Knowledge and Awareness Regarding Management and Prevention of Selected Respiratory Diseases |
1 week By understanding the respiratory system and the potential hazards present in factory environments, workers can take proactive steps to protect their health. Using the right protective equipment, ensuring good ventilation, and adhering to safe work practices are key measures to prevent respiratory issues and maintain a healthy working environment |
| Comparator Agent |
NILL |
NILL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants who are readily accessible and willing to participate in the research & ensuring feasible data collection
2. Both male and female factory workers to ensure a comprehensive understanding of the prevalence and contributing factors without gender bias.
3. Workers employed in different sectors within the industrial area (e.g., manufacturing, textiles, chemicals) to account for potential sector-specific risk factors.
4. Workers without pre-existing respiratory conditions .
|
|
| ExclusionCriteria |
| Details |
1. Factory workers who are on leave at the time of data collection
2. Workers employed on a part-time or temporary basis
3. Workers who decline to provide informed consent to participate in the study
4. Workers with pre-existing respiratory conditions
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
i.Improve the knowledge of respiratory disease
ii.Raise the prevention of respiratory disease
iii. Use of effective physical habits for better respiration
|
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i. Prolonged smoking cessation
ii. Use of effective breathing exercise to maintain the normal respiratory function
iii. Improved respiratory literacy in selected area
iv. Improved respiratory health care literacy
v. Early detection of respiratory disease will reduce incidence of further prevalence of respiratory disease progression in the selected area
vi. to estimate the pooled prevalence of respiratory symptoms and identify associated factors among industry workers .
|
6 week |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A study of Effectiveness of interventional package of knowledge and awareness regarding management and prevention of selected respiratory disease and its contributing factors among factory workers.
Objectives 1. To assess the pre-existing knowledge and practice regarding the prevention and management of selected respiratory diseases and their contributing factors among factory workers. 2. To develop and implement an interventional package to improve knowledge and practice related to respiratory disease prevention and management. 3. To evaluate the effectiveness of the interventional package by comparing pre-test and post-test knowledge and practice scores among factory workers. 4. To identify the association between pre-test knowledge and practice scores with their selected demographic variables. 5. To determine the long-term impact of the interventional package on knowledge retention and behavior modification among factory workers. Hypothesis Hypothesis 1: There will be a significant difference between the pre-test and post-test mean knowledge scores of factory workers regarding the prevention and management of selected respiratory diseases after the intervention. Hypothesis 2: There will be a significant difference between the pre-test and post-test mean practice scores of factory workers regarding the prevention and management of selected respiratory diseases after the intervention. Hypothesis 3: There will be a significant association between pre-test knowledge scores and selected demographic variables (such as age, education level, smoking habits, and duration of factory work). Hypothesis 4: There will be a significant association between pre-test practice scores and selected demographic variables. Hypothesis 5: The interventional package will have a sustained impact on knowledge and practice levels among factory workers, as measured during follow-up assessments. |