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CTRI Number  CTRI/2021/03/032227 [Registered on: 23/03/2021] Trial Registered Prospectively
Last Modified On: 22/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   KAP study on COVID 19 
Scientific Title of Study   Knowledge, Attitude, Practice of biomedical waste management during COVID 19 pandemic: A single centered study 
Trial Acronym  KAP COVID 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Meenu PS 
Designation  PG STUDENT 
Affiliation  PSPH 
Address  Department of Public Health, HOSPITAL ADMINSTRATION PSPH MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  9846979150  
Fax    
Email  writetome403@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Somu G  
Designation  Head of Department of Hospital administration 
Affiliation  PSPH 
Address  Department of Hospital Administration PSPH MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448463186  
Fax    
Email  somu.g@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Meenu PS 
Designation  PG STUDENT 
Affiliation  PSPH 
Address  Department of hospital administration PSPH MAHE Manipal

Udupi
KARNATAKA
576104
India 
Phone  9846979150  
Fax    
Email  writetome403@gmail.com  
 
Source of Monetary or Material Support  
Prasanna School of Public Health 
 
Primary Sponsor  
Name  Dr Meenu Self 
Address  MHA Student PSPH MAHE Manipal  
Type of Sponsor  Other [self sponsored] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSomuG  Kasturba Hospital Manipal  Kasturba Hospital MAdhavanager, Department of Infectious Diseases Manipal Udupi Districs
Udupi
KARNATAKA 
9448463186

somu.g@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KH Institutional Ethics Commmittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Healthcare workers 
 
ExclusionCriteria 
Details  Not willing to participate 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
to understand the awareness on COVID protocols by healthcare personnel so that training can be initiated   2-3 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
Better knowledge in handling COVID waste handling and help in containment of COVID cases   2-3 MONTHS 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   30/03/2021 
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="0"
Months="0"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Will be published after the study is completed  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 Title of the project: Knowledge, Attitude, Practice of biomedical waste management
during COVID 19 pandemic: A single centred study

Type of study : Prospective single centred study

 Aims & objectives :
Aim : To assess knowledge, attitude, practice of health care personals
regarding BMW management during COVID-19 pandemic
Objective :a)To assess safety precautions during handling the biomedical waste in the study centre
b) To assess the levels of knowledge, attitude and practice among doctors, nurses,
technicians and house keeping staff 

Justification for study : According to Central Pollution Control Board report, India generates about 101 metric Tonnes per day of COVID-19 related biomedical waste.During the COVID-19 outbreak, many types of additional medical and hazardous waste are generated including infected mask, gloves, syringes, samples, drain bags,urine bags, body fluids, empty ampules etc. Disposal of biomedical waste including PPE kits worn by healthcare worker became a challenge during the ongoing pandemic. COVID-19 cases increased among individuals employed in garbage collection and disposal due to mismanagement of biomedical waste including PPE.Basic infection control practices are the only measures for containment. Thus, this study purpose to prevent general exposure to harmful effect of COVID-19 related biomedical waste.

Department involved: Department of Quality, Department of Hospital Infection control and management

Study period: January – April 2021
Sample size : 200 study sample including all health care personnel
Materials and methods:
Inclusion criteria and exclusion criteria
Inclusion criteria:
- All healthcare staff who are participating in the study
Exclusion criteria:

- Subjects who are not willing to participate in the study
Statistical methods: Descriptive statistics
 Tools used : Structured questionnaire to assess the knowledge, attitude and
practice on biomedical waste management and safety precaution on handling
COVID-19 related biomedical waste.

 Detailed description of procedure/processes: After obtaining approval from the
departmental dissertation committee and Institutional Ethics Committee, the
prospective single centred study will begin. The participants will be approached by
structured questionnaire related to the knowledge, attitude and practice of handling
the COVID-19 related biomedical waste will be provided to doctors, nurses,
technician and housekeeping staff to answer within stipulated time. The questions
on knowledge appraises the participant’s knowledge on attributes related to the
colour coding and their identification of biomedical hazard symbol, waste categories
and hospital policies for biomedical waste management. The question on attitude
were related to matters like is biomedical waste hazardous, waste management is a
team work and safe management of waste is an extra burden of work. The question
of practice appraises if the study respondents had undergone any training on
biomedical waste management, disposal of sharps in puncture proof container and
disinfection of sharps are carried out at the point of generation.

Outcome measures: Assessing how safely the staffs are handling the COVID-19
related biomedical waste
 Potential risk : Minimal risk
Benefits : The present status of healthcare worker’s awareness with respect to
BMWM will aid the authorities to expand the programme or master plan for polish
up or upgrade the situation in future.
 Ethical considerations and methods to address issues: IEC clearance will be taken
before the start of the study. Informed consent from participant and use of indirect
identifier to ensure confidentiality.
 Budget and proposed funding source: Not applicable.
 Review of literature:
In a study done by Divya Rao, M.R Dhakshaini, Ameet Kurthukoti and Vidhya G.Doddawad, titled “Biomedical waste management: A study on assessment of knowledge, attitude and practices among Health care professionals in a tertiary care teaching hospital” A cross sectional study was carried out using questionnaire as the study tool among the health care professionals in a tertiary care teaching hospital. The study demonstrated gaps in the knowledge amongst all the cadres of the study respondents. The knowledge in relation to BMW Management including the hospital BMW protocols was more desirable among doctors, but practical facets were better in nurses and the lab technicians. Knowledge, Attitude and Practice amongst the different cadres of staff members were found to be significant statistically. In another study done by Keshvi Chauhan, Summaiya Mullan, Yogita Mistry titled
“Practices and barriers for personal protective Equipment among Health care workers during COVID-19 pandemic management at tertiary care government hospital of south Gujarat, India” This was a cross-sectional study designed during the COVID-19 pandemic management in the South Gujarat region, to analyse the knowledge,attitude and practices of health care workers about their usage of personal protective equipment. A semi-structured questionnaire-based study was prepared, deriving pointers from previous experience of seasonal flu outbreaks.225 participants enrolled who were doctors, resident doctors, nurses, lab technicians, ward boys and food distributors. As a result, analysis of the barriersrelated questions show good preparedness by the medical institution.Overall we found good knowledge, attitude and practice related to PPE during COVID-19 pandemic  management. There are few gaps found in the knowledge of donning of PPE (p-0.0075), N-95 mask related knowledge (p-0.01) and the attitude that PPE use causes discomfort while nursing patients.In an effectiveness study titled “Analysis of compliance and barriers for hand hygiene practices among health care workers during COVID-19 pandemic management in tertiary care hospital of India- an important step for second wave preparedness” done by Keshvi Chauhan, Yogita Mistry, Summaiya Mullan this study was planned for analysis of barriers and practices of hand hygiene among health care workers which determine the adherence of hand hygiene in medical practice. This was a cross-sectional study designed during COVID-19 pandemic management to analyze the barriers and knowledge, attitude and practices in health care workers for hand hygiene. Semi-structured questionnaires based
study based on previous experience of seasonal flu outbreak was make to know barriers as well as to analyze the knowledge, attitude and practices of Health care workers.The “Barriers” related questions’ analysis showed that hand hygiene facilities, with the supply of soap, hand rub, basins with adequate as well as clean water, are available at various places in the Hospital. In knowledge related questions, major gaps are found in 5 moments of hand hygiene and regarding aspects of alcohol-based hand-rub. Majority HCWs show a good attitude towards questions that hand hygiene is an important thing to do along with other works and they feel frustrated when others or they themselves omit hand hygiene. But the attitude toward hand hygiene when hands are not visibly soiled and when working with gloved hand showed a wrong attitude. There is a major gap in practices of hand hygiene. The majority feel hand hygiene is difficult due to work pressure, sometimes they forgot, they feel it difficult to adhere due to more steps during an emergency. Good preparedness by Government and Institute for supplying adequate hand hygiene facilities in the work area for health care workers. But there were few gaps found in knowledge and attituderelated questionnaires and major gaps in practices were found 

15. References:
1. CPCB guidelines for handling, treatment and disposal of waste generated during
treatment/diagnosis/quarantine of COVID-19 patients 25th March 2020.
2. Analysis of Compliance and Barriers for Hand Hygiene Practices among Health
Care Workers during COVID-19 Pandemic Management in Tertiary Care Hospital
of India—An Important Step for Second Wave Preparedness Keshvi Chauhan,
Yogita Mistry, Summaiya Mullan
3. Divya Rao1

, M. R. Dhakshaini2

, Ameet Kurthukoti3 and Vidya G. Doddawad
Biomedical Waste Management: A Study on Assessment of Knowledge, Attitude
and Practices Among Health Care Professionals in a Tertiary Care Teaching
Hospital

4. Keshvi Chauhan
1*
, Summaiya Mullan
2
, Yogita Mistry Practices and Barriers for
Personal Protective Equipment among Health Care Workers during COVID-19
Pandemic Management at Tertiary Care Government Hospital of South Gujarat,
 
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