| CTRI Number |
CTRI/2025/02/079908 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [traning programme for the nurses] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Training for Nurses on caring for Suicide Attempt Individuals |
|
Scientific Title of Study
|
Effectiveness of training program on communication and practice skill of nurses caring for attempted suicide patients at selected emergency units |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajesh Kumar T K |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
College of Nursing
AIIMS
Ansari Nagar East New Delhi Delhi 110029
All India Institute of Medical Sciences
Ansari Nagar East New Delhi Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
09729389569 |
| Fax |
|
| Email |
ajesh.ktk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajesh Kumar T K |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
College of Nursing
AIIMS
Ansari Nagar East New Delhi Delhi 110029
College of Nursing
AIIMS
Ansari Nagar East New Delhi Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
09729389569 |
| Fax |
|
| Email |
ajesh.ktk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajesh Kumar T K |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
College of Nursing
AIIMS
Ansari Nagar East New Delhi Delhi 110029
College of Nursing
AIIMS
Ansari Nagar East New Delhi Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
09729389569 |
| Fax |
|
| Email |
ajesh.ktk@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Ajesh Kumar T K |
| Address |
All India Institute of Medical sciences Ansari Nagar East
New Delhi Delhi 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| not applicable |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ajesh Kumar T K |
ROOM no 1, 2, and 3 of the emeregency unit of All India Institute of Medical Sciences, New Delhi |
Sri Aurobindo Marg Ansari Nagar Ansari Nagar East New Delhi Delhi 110029
New Delhi
DELHI |
9729389569
ajesh.ktk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nurses working in the emergency units |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
routine training |
The control group will get the routine training which are as a their regular training conducted by nursing education department |
| Intervention |
Training programme on communication and practice for nurses caring for attempted suicide patients |
after obtaining permission from the nursing superintend. The nurses in the intervention group will receive four-hour training program will be conducted by the principal investigator over four days, with one-hour sessions
each day. Training will take place in small groups of 4-6 nurses at the nursing stations of selected units. Additionally, a
booklet containing all the necessary details will be provided to the participants.
The four hours training program consist of five modules about suicide, suicide risk assessment,
communication and practice related to care of suicide attempters in three interactive sessions. In this
training program, participants will learn in small groups (5-6 members), by brainstorming, question and
answer, interactive lecture, and case scenarios. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Nurses who are working the emergency units and involved in caring for attempted suicide patients
Nurses who have a minimum of one year or more experience in caring for an attempted suicide
patients in the emergency unit |
|
| ExclusionCriteria |
| Details |
Nurses who are not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the communication skills of the nurses |
at the baseline, at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Practice skills of the nurses |
at baseline & four weeks |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
20/02/2025 |
| 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 Yet Recruiting |
| 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
|
Healthcare workers have shown substantial effectiveness with favorable outcomes from educational interventions aimed at improving their knowledge, changing their attitudes, and increasing their levels of competence caring for suicidal patients. However, these educational initiatives are not credited enough, particularly in India. The research on nurses’ training in caring for suicide-attempted patients is scant. Research Question? Is training program caring for attempted suicide patients is effective on communication, practice skills of nurses working in selected emergency units?
Primary Objectives: 1. To determine the effectiveness of training program on communication skill of nurses caring for attempted suicide patients at selected emergency units 2. To determine the effectiveness of training program on practice skill of nurses caring for attempted suicide patients at selected emergency units. Hypotheses: H1: There will be a statistically significant change in the communication skills of the nurses caring for attempted suicide patients between the experimental and control group following the training programme at p<0.05 level. H2: There will be a statistically significant change in the practice skills of the nurses caring for attempted suicide patients between the experimental and control group following the training programme at p<0.05 level. |