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CTRI Number  CTRI/2022/07/044343 [Registered on: 26/07/2022] Trial Registered Prospectively
Last Modified On: 20/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Testing Knowledge, Attitudes, and Practice of Hospital Waste among Nursing Staff in Urban India 
Scientific Title of Study   Assessment of Knowledge, Attitudes, and Practice of Biomedical Waste Management Among Nursing Staff in Urban India 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Megha Reddy 
Designation  Research Assistant 
Affiliation  Student 
Address  Education and Research Department, Bangalore Hospice Trust-Karunashraya 40, Varthur Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Marathahalli, Bengaluru, Karnataka 560037

Bangalore
KARNATAKA
560037
India 
Phone  9108627439  
Fax    
Email  mreddy12@jh.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Seema Rao 
Designation  Senior Research Director 
Affiliation  Bangalore Hospice Trust-Karunashraya 
Address  Bangalore Hospice Trust- Karunashraya 40, Varthur Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Marathahalli, Bengaluru, Karnataka 560037

Bangalore
KARNATAKA
560037
India 
Phone  9892336650  
Fax    
Email  seema.rao@karunashraya.org  
 
Details of Contact Person
Public Query
 
Name  Megha Reddy 
Designation  Research Assistant 
Affiliation  Bangalore Hospice Trust-Karunashraya 
Address  Education and Research Department, Bangalore Hospice Trust-Karunashraya 40, Varthur Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Marathahalli, Bengaluru, Karnataka 560037

Bangalore
KARNATAKA
560037
India 
Phone  9108627439  
Fax    
Email  mreddy12@jh.edu  
 
Source of Monetary or Material Support  
Bangalore Hospice Trust-Karunashraya 
 
Primary Sponsor  
Name  Bangalore Hospice Trust Karunashraya 
Address  40, Varthur Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Marathahalli, Bengaluru, Karnataka 560037 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  N/A 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Megha Reddy  Bangalore Hospice Trust-Karunashraya  Education and Research Department, Bangalore Hospice Trust-Karunashraya 40, Varthur Rd, Vaikuntam Layout, Lakshminarayana Pura, Kundalahalli, Marathahalli, Bengaluru, Karnataka 560037
Bangalore
KARNATAKA 
9108627439

mreddy12@jh.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Karunashraya Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  No health condition is being assessed 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Nurses and nursing aides who consent to participate in the study 
 
ExclusionCriteria 
Details  Nursing staff who are unwell or on leave on the day of questionnaire administration 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Gaps in Knowledge, Attitude, and Practices on biomedical waste management assessed through a close-ended questionnaire and an open-ended discussion with nursing staff.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   29/07/2022 
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="1"
Days="28" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This research study is a cross-sectional study that uses mixed methods to capture knowledge, attitudes, and practices, of biomedical waste management among nursing staff in a cancer hospice located in urban India. This study consists of two methods to fulfill its aim (1)  an open-ended discussion with 7 nursing aides and nurses to capture where they face issues with regard to biomedical waste management in the wards and (2)  Administering a  close-ended questionnaire consisting of 14 questions on knowledge, 5 questions on attitude, and 7 questions on practice of biomedical waste management to the nursing staff.
The subjects of the study include all nursing staff at the hospice as they had the greatest contact with biomedical waste in the wards. Results from the open-ended discussion will be used to conduct a root-cause analysis using the Ishikawa or fishbone diagram. The proportion of answers answered correctly followed by the confidence intervals will be analyzed from the questionnaire. Analysis using one-way ANOVA will be done to see whether there was a difference in the KAP score based on the nursing staff’s age, education level and years of experience at the hospice.

 
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