| CTRI Number |
CTRI/2016/10/007392 [Registered on: 21/10/2016] Trial Registered Retrospectively |
| Last Modified On: |
20/10/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
hospital waste management education and training program among paramedical staff and attenders for the period of 12 months |
|
Scientific Title of Study
|
Evaluation of educational and training intervention on biomedical waste management among paramedical staff and attenders in a teaching dental institution- a 12 months follow up study. |
| Trial Acronym |
BMWM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR AMEENA MUSARETH V M |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
THE OXFORD DENTAL COLLEGE AND HOSPITAL |
| Address |
THE OXFORD DENTAL COLLEGE AND HOSPITAL
Bangalore
THE OXFORD DENTAL COLLEGE AND HOSPITAL
Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
9844544208 |
| Fax |
25734656 |
| Email |
draamina.musareth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ARCHANA KRISHNA MURTHY |
| Designation |
PROFESSOR |
| Affiliation |
THE OXFORD DENTAL COLLEGE AND HOSPITAL |
| Address |
THE OXFORD DENTAL COLLEGE AND HOSPITAL
Bangalore
THE OXFORD DENTAL COLLEGE AND HOSPITAL
Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
9845620292 |
| Fax |
25734656 |
| Email |
archanakm20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AMEENA MUSATERTH V M |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
THE OXFORD DENTAL COLLEGE AND HOSPITAL |
| Address |
THE OXFORD DENTAL COLLEGE AND HOSPITAL
Bangalore
THE OXFORD DENTAL COLLEGE AND HOSPITAL
Bangalore
Bangalore
KARNATAKA
560068
India |
| Phone |
9844544208 |
| Fax |
25734656 |
| Email |
draamina.musareth@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ameena |
| Address |
The Oxford Dental College and Hospital
Bangalore |
| 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 |
| DR AMEENA MUSARETH V M |
The Oxford Dental College and Hospital |
Hosur main road
Bommanahalli
Bangalore
Bangalore
KARNATAKA |
9844544208
25734656
draamina.musareth@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals who are working in a hospital which produces infected waste |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Educational and training intervention |
All the paramedical staff and attenders will be given educational and training intervention for the period of 12 months. Pre training questionnaire will be applied to assess the knowledge and practices at baseline. They will be given training on biomedical waste management at 3 months interval beginning from baseline, at the end of 3rd, 6th, and 9th month. Intervention will consist of lectures in the language they understand, interactive sessions, demonstration and hands on. The training module will include aspects on the rules and regulations, hazards of biomedical waste, demonstration of biomedical waste segregation, disinfection methods for various categories of waste, personal protective equipment and after care exposure to needle prick injuries.
|
| Comparator Agent |
Pre training and post training questionnaire |
NilThe assessment tool of intervention effectiveness will follow the Kirkpatrick’s model of training evaluation in every 3 months interval.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All the paramedical staff and attenders of both genders who are working in The Oxford Dental College and Hospital,Bangalore, and who are 20 to 60 years. |
|
| ExclusionCriteria |
| Details |
Who are not giving consent are excluded in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the pre training and post training knowledge, attitude and practice about bio medical waste management |
At baseline, end of 3rd, 6th, 9th and 12th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes will be measured by weighing color coded bags using a calibrated weighing machine at the central collection point. |
One randomly selected day once fortnightly. At the end of 12 months. |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/10/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None done yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
OBJECTIVES OF THE STUDY:
To assess the existing knowledge, attitude, and practices on Bio Medical Waste
Management among the paramedical staff of The Oxford Dental College, Hospital and
Research Centre.
To evaluate the effectiveness of educational and training program on the knowledge,
attitude and practices of Bio Medical Waste Management among the paramedical staff of
The Oxford Dental College, Hospital and Research Centre.
PLAN OF WORK AND METHODOLOGY
SOURCE OF DATA:
Paramedical staff consists of nurses, lab technicians, and attenders of The Oxford Dental College,
Hospital and Research Centre.
STUDY DESIGN:
This will be a educational and training intervention. This study will be conducted in, The Oxford
Dental College. The study sample consists of all paramedical staff which include nurses, lab
technicians and attenders who are willing to participate in the study.
All the paramedical staff mentioned above in this institution working in 9 dental departments and
teaching medical departments will be included in the study. Written informed consent will be taken
from all the participants before they are included in the study. Pre training questionnaire will be
applied to assess the knowledge and practices at baseline. They will be given training on BMWM at
3 months interval beginning from baseline, at the end of 3rd , 6th and 9th month. Intervention consist
of lectures in the language they understand, interactive sessions, demonstration and hands on. The
training module will include aspects on the rules and regulations, hazards of BMW, demonstration
of BMW segregation, disinfection methods for various categories of waste, personal protective
equipment and after care exposure to needle prick injuries. The assessment tool will follows the
Kirkpatrick’s model of training evaluation consists of 4 phases.
Phase 1: Reaction evaluation
In this phase assessment will be done on how the trainees feel about learning experience; assessed
through a standardized and validated feedback forms at the end of each training session.
Phase 2: Learning evaluation
In this phase assessment will be done through standardized and validated questionnaire at baseline
and at the end of each session to assess their knowledge and practice of BMWM.
Phase 3: Behavior evaluation
In this phase observation will be done to assess the implementation of the BMWM practices by
visiting the respective departments where they are working, on a randomly selected day once
fortnightly using a standardized checklist.
Phase 4: Results evaluation
This will be done by weighing color coded bags using a calibrated weighing machine at the c at the
central collection point on one randomly selected day once fortnightly. At the end of 12 months
feedback will be taken from the coordinators of BMWM committee in each department, college
manager and the person who is collecting the disposal bags at the central collecting point (Maridi
Eco), through a standardized questionnaire.
Duration: 12 months
|