| CTRI Number |
CTRI/2017/09/009747 [Registered on: 13/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
11/09/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
MIXED METHODOLOGY, SEQUENTIAL-EXPLANATORY |
| Study Design |
Other |
|
Public Title of Study
|
Aggression management and violence prevention training for nurses working in psychiatric and emergency settings |
|
Scientific Title of Study
|
Effectiveness of participatory education program on Aggression management and Violence prevention among nursing personnel working in psychiatric and emergency settings of selected hospitals of DK and Udupi districts of karnataka |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BINIL V |
| Designation |
ASSISTANT PROFESSOR,SENIOR SCALE |
| Affiliation |
MANIPAL SCHOOL OF NURSING |
| Address |
MANIPAL SCHOOL OF NURSING, CENTRE FOR BASIC SCIENCES, BEJAI, MANGALORE
MANIPAL SCHOOL OF NURSING, CENTRE FOR BASIC SCIENCES, BEJAI, MANGALORE
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9844387432 |
| Fax |
08202922443 |
| Email |
binilvp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BINIL V |
| Designation |
ASSISTANT PROFESSOR, SENIOR SCALE |
| Affiliation |
MANIPAL SCHOOL OF NURSING |
| Address |
MANIPAL SCHOOL OF NURSING, CENTRE FOR BASIC SCIENCES, BEJAI, MANGALORE
MANIPAL SCHOOL OF NURSING, CENTRE FOR BASIC SCIENCES, BEJAI, MANGALORE
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9844387432 |
| Fax |
08202922443 |
| Email |
binilvp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BINIL V |
| Designation |
ASSISTANT PROFESSOR, SENIOR SCALE |
| Affiliation |
MANIPAL SCHOOL OF NURSING |
| Address |
MANIPAL SCHOOL OF NURSING, CENTRE FOR BASIC SCIENCES, BEJAI, MANGALORE
MANIPAL SCHOOL OF NURSING, CENTRE FOR BASIC SCIENCES, BEJAI, MANGALORE
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9844387432 |
| Fax |
08202922443 |
| Email |
binilvp@gmail.com |
|
|
Source of Monetary or Material Support
|
| MANIPAL UNIVERSITY, MANIPAL, UDUPI, KARNATAKA, 576104 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [NOT APPLICABLE] |
|
|
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 |
| BINIL V |
KMC HOSPITAL, |
DEPARTMENT OF NURSING, SECOND FLOOR,ATTAVARA, MANGALORE, kARNATAKA
Dakshina Kannada
KARNATAKA |
9844387432
08202922443
binilvp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE, MANGALORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NURSES WHO ARE HEALTHY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
TRAINING FOR NURSES |
ONE GROUP PRE TEST POST TEST DESIGN |
|
|
Inclusion Criteria
|
| Age From |
23.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Nurses having minimum of 6 months experience in psychiatric, emergency or intensive care unit,
Willingness to engage in participatory training program |
|
| ExclusionCriteria |
| Details |
Nurses who already received the training, Nurses those who are not involved in direct patient care |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| safe and seccure care |
4 YEARS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| COMPETENCY OF NURSES TO HANDLE VIOLENCE INCIDENCE AND LESS VIOLENCE INCIDENCE IN PSYCHIATRIC WARD |
1 YEAR |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/09/2013 |
| 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="4"
Months="5"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
One article published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
the objective of the study is to find the effectiveness of the aggression management and violence prevention training program. the purpose of the study is to provide safe and secure care to both patients and nurses in psychiatric and emergency settings. the study also facilitate to develop staff development program on aggression management and violence prevention. |