| CTRI Number |
CTRI/2018/12/016770 [Registered on: 21/12/2018] Trial Registered Prospectively |
| Last Modified On: |
24/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Other |
|
Public Title of Study
|
Identifying the factors which contributes to the incidences of needle prick injuries among healthcare workers of a tertiary care hospital. |
|
Scientific Title of Study
|
Exploring the contributors of needle stick injuries at a tertiary care hospital. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nahima Akthar |
| Designation |
B.Sc. Nursing, MHA 2nd year student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9945652904 |
| Fax |
08202570062 |
| Email |
nahimaakthar24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Usha Rani |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal
Prasanna School of Public Health, Manipal Academy of Higher Education, Madhav Nagar, Manipal-576104.
Udupi
KARNATAKA
576104
India |
| Phone |
9480980246 |
| Fax |
08202570062 |
| Email |
usha.rani@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveen Kumar P |
| Designation |
Professor and Head of the Department |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Hospital Administration, Kasturba Medical College Manipal, Madhav Nagar, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9019164899 |
| Fax |
08202570062 |
| Email |
naveen.kumar@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital Manipal. |
| Prasanna School of Public Health, Manipal Academy of Higher Education. |
|
|
Primary Sponsor
|
| Name |
Nahima Akthar |
| Address |
Prasanna School of Public Health, MAHE, Manipal-576104 |
| 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 |
| Nahima Akthar |
Kasturba Hospital, Manipal. |
Casualty, Intensive Care Units, Operation theatres, Surgical wards of Kasturba Hospital, Madhav Nagar, Manipal.
Udupi
KARNATAKA |
9945652904
nahimaakthar24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Needle stick injuries |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Healthcare workers with needle stisk injuries |
|
| ExclusionCriteria |
| Details |
Healthacre workers with needle stick injury denying to give consent for participation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Age:18-30years, Experience:Fresher, Working Unit:Casuality, ICU, OT, Working hours:9am to 6pm,Disposal or handling of needles as per protocol or not |
Age:18-30years, Experience:Fresher, Working Unit:Casuality, ICU, OT, Working hours:9am to 6pm,Disposal or handling of needles as per protocol or not |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the prevalence of needle stick injuries and to explore and prioritise the contributors of needle stick injuries. |
Starting from January 2019 till June 2019. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "44"
Final Enrollment numbers achieved (India)="44" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2019 |
| Date of Study Completion (India) |
30/04/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aim: Exploring the contributors of needle stick injuries at a tertiary care hospital. Objectives: To identify the prevalence of needle stick injuries, to explore and prioritize the contributors of needle stick injuries. Description of the primary purpose of the protocol: The study invoves healthcare workers with injuries reporting to the Hospital Infection Control Committee of Kasturba Hospital, Manipal. A self-generated data collection form is used as a study tool. This tool is used for Root Cause analysis which is to explore the contributors of needle stick injuries. The written consent of all participants in the local language will be obtained before providing the data collection form. The participant will be informed about the pupose and procedures of the study by providing participant information sheet. The total confidentiality of the iformation ismaintained by not using any identifiers of the participants. The information obtained from the study will help to manage healthcare workers with needle stick injury in future. The Hospital Infection Control Committee can take up this and future actions will be taken to prevent needle stick injuries. |