| CTRI Number |
CTRI/2024/08/072258 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Impact of Pro-Safe Work Training on Awareness and Perception of Workplace Safety Among BSc Nursing Interns in Udupi District, Karnataka |
|
Scientific Title of Study
|
Effectiveness of a Pro-safe work training (PSWT) on awareness towards prevention of workplace violence and perception of workplace safety among BSc. Nursing interns in selected nursing colleges in Udupi district ,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 |
Payel Sarkar |
| Designation |
Msc Nursing Student |
| Affiliation |
Manipal College of Nursing |
| Address |
Room Number-601,6th floor, Department of Psychiatric (Mental Health) Nursing, Manipal College of Nursing,Manipal Academy of Higher Education,Manipal, 576104, Udupi District, Karnataka, India
Manipal Academy of Higher Education Madhav Nagar Manipal, 576104, Udupi District, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8618742897 |
| Fax |
|
| Email |
payelsrkr19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binil V |
| Designation |
Additional Professor |
| Affiliation |
Manipal College of Nursing Manipal |
| Address |
Room Number-601, 6th floor, Department of Psychiatric (Mental Health) Nursing, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, 576104, Udupi District, Karnataka
Manipal College of Nursing Manipal
Manipal Academy of Higher Education, Manipal, 576104, Udupi District, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9844387432 |
| Fax |
|
| Email |
vp.binil@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sanju Pant |
| Designation |
Lecturer |
| Affiliation |
Manipal college of nursing Manipal |
| Address |
Room Number-601, 6th floor, Manipal College of Nursing,Manipal Academy of Higher Education, Manipal, 576104, Udupi District, Karnataka, India
Manipal College of Nursing Manipal
Manipal Academy of Higher Education, 576104, Udupi District, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9991402789 |
| Fax |
|
| Email |
sanju.pant@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Nursing |
|
|
Primary Sponsor
|
| Name |
Payel Sarkar |
| Address |
Room Number-601, 6th floor, Manipal College of Nursing, Manipal Academy of Higher Education, Manipal, 576104, Udupi District, Karnataka, India |
| Type of Sponsor |
Other [Self funding ] |
|
|
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 |
| Ms Payel Sarkar |
Manipal College of Nursing |
Room number 608 Department of Psychiatric (Mental Health) Nursing 6th floor
Manipal College of Nursing , MAHE, Manipal, Udupi District , 576104
Udupi
KARNATAKA |
8618742897
payelsrkr19@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Pro-safe work training (PSWT) |
The study design is one group pretest-posttest. The pre-test will be carried out before the intervention and the post-test will be done after seven days of the intervention.
The intervention is scheduled for four days, one hour per day. The educational intervention includes resource materials such as lectures, role plays, and practical demonstrations on various subtopics like de-escalating techniques, self-defence techniques, communication skills, clear reporting mechanisms, the Legal Protection Act and various helpline numbers.
For day 1: The researcher will brief about workplace violence like the meaning of workplace violence, types of workplace violence, what could be the potential causes for workplace violence & a lecture on communication skills like what pitch should be used while communicating with the violent patients, to be empathetic while communicating, actively listening to them rather than reacting aggressively, etc to improve interpersonal relationship.
Day 2: Demonstration self-defence techniques like using a defence mechanism when the patient becomes physically violent, also using de-escalating techniques like staying calm and composed, actively listening to whatever the patient is saying and not reacting aggressively, maintaining non-threatening posture, validating patient emotions, speaking softly etc.
Day 3: It will include a role play on a clear reporting mechanism like what are the steps to be followed for reporting the incident according to the hospital policy.
Day 4: There will be a discussion on various legal protection acts & helpline numbers, and how it is useful to them.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Only IV Year BSc. Nursing (interns) from Manipal College of Nursing, MAHE, Manipal Udupi District Karnataka. |
|
| ExclusionCriteria |
| Details |
Students with any mental health issues |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pro-safe work training (PSWT) Awareness towards workplace violence and perception on workplace safety |
04weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
16/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study aims to determine whether a training program effectively creates awareness towards preventing workplace violence and perception of workplace safety among undergraduate nursing students in selected nursing colleges in the Udupi district, Karnataka. This will help the nursing students to recognize the escalating behaviours at the workplace that are considered threats and violence to them and be able to identify the appropriate interventions needed to de-escalate them or to protect themselves from threats or violence at the workplace. |