| CTRI Number |
CTRI/2025/03/082538 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational module] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the effectiveness of verbal de-escalation module among psychiatry residents and nursing staff while dealing with aggressive patients. |
|
Scientific Title of Study
|
Evaluation of a Verbal De-escalation skills training program for psychiatry postgraduate students and nurses - A Quasi-Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tharani Sree Sukumar |
| Designation |
Psychiatry Resident |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
Room no.1,5th floor, Department of Psychiatry,
PSG Institute of Medical Sciences and Research,
Post Box 1674,
Off Avinashi Road, Peelamedu, Coimbatore
Tamil Nadu, INDIA.
Coimbatore TAMIL NADU 641004 India |
| Phone |
7708914572 |
| Fax |
|
| Email |
tharanisreesugumar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Raghuthaman G |
| Designation |
Psychiatrist |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
Room no.2,5th floor, Department of Psychiatry,
PSG Institute of Medical Sciences and Research,
Post Box 1674,
Off Avinashi Road, Peelamedu, Coimbatore
Tamil Nadu, INDIA.
Coimbatore TAMIL NADU 641004 India |
| Phone |
9789459987 |
| Fax |
|
| Email |
raghuthaman_gopal@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Raghuthaman G |
| Designation |
Psychiatrist |
| Affiliation |
PSG Institute of Medical Sciences and Research |
| Address |
Room no.2,5th floor, Department of Psychiatry,
PSG Institute of Medical Sciences and Research,
Post Box 1674,
Off Avinashi Road, Peelamedu, Coimbatore
Tamil Nadu, INDIA.
Coimbatore TAMIL NADU 641004 India |
| Phone |
9789459987 |
| Fax |
|
| Email |
raghuthaman_gopal@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| PSG INSTITUTE OF MEDICAL SCIENCES AND RESEARCH, Avinashi Road, Peelamedu, Coimbatore,TamilNadu - 641004 |
|
|
Primary Sponsor
|
| Name |
Dr Tharani Sree Sukumar |
| Address |
PSG Institute of Medical Sciences and Research,
Post Box 1674,
Off Avanashi Road, Peelamedu, Coimbatore 641004,
Tamil Nadu, INDIA. |
| Type of Sponsor |
Other [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 Tharani Sree Sukumar |
PSG Institute of Medical Sciences and Research |
Room no.1,5th floor, Department of Psychiatry,
PSG Institute of Medical Sciences and Research,
Post Box 1674,
Off Avinashi Road, Peelamedu, Coimbatore
Tamil Nadu, INDIA. Coimbatore TAMIL NADU |
7708914572
tharanisreesugumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, PSG IMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Verbal De escalation skills training program |
An educational module for verbal de escalation skills which include didactic lecture and role plays which is around 2-3 hours.
The module will be taught once after the pre test. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.M.D Postgraduates in the Department of Psychiatry
2.Nursing staff in Department of Psychiatry
3.Postgraduate Nursing students who are posted in the Department of Psychiatry.
|
|
| ExclusionCriteria |
| Details |
1.Nursing staff who are temporarily deputed in the psychiatry department.
2.MD postgraduates other than psychiatry who are temporarily posted in the department for a duration of 2 weeks. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Verbal de-escalation skills assessed by English Modified De-escalating Aggressive Behaviour Scale (EMDABS score) following training. |
One week before and after the training module. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Confidence in handling aggressive patients which is assessed by % improvement in The Adapted Version of the Confidence in Coping with Patient Aggression Instrument (CCPAI scale) following intervention. |
One week before and after the training module. |
| No. of code white announcements per month: A call for help to gather security persons and staff from other places to come to the psychiatry ward to contain patients showing aggression. |
One month before and after the training module. |
| No. of physical restraints per month |
One month before and after the training module. |
| No. of sentinel events per month. |
One month before and after the training module |
|
|
Target Sample Size
|
Total Sample Size="34" Sample Size from India="34"
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)
|
01/04/2025 |
| 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="2" 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
|
This study aims to evaluate the effectiveness of a verbal de-escalation skills training program for psychiatry postgraduate students and nurses in managing aggression in psychiatric inpatient settings. The hypothesis is that structured training will improve verbal de-escalation skills and increase confidence in handling aggressive patients. The study population consists of psychiatry postgraduate students and psychiatric ward nurses. The study employs a quasi-experimental design with pre- and post-training assessments. The training module, developed through focus group discussions with experienced psychiatric professionals, includes didactic lectures, role-play exercises, and interactive discussions covering key de-escalation techniques such as empathetic communication, safety maintenance, and conflict resolution. The primary outcome measures include improvement in verbal de-escalation skills, assessed using the English Modified De-escalating Aggressive Behaviour Scale (EMDABS), and enhanced confidence in managing aggression, measured with an adapted version of the Confidence in Coping with Patient Aggression Instrument. Participants will engage in simulated patient interactions before and after training, with video recordings evaluated by blinded raters. Additionally, the study will track hospital incident reports, including the frequency of code white alerts, physical restraints, and sentinel events pre- and post-intervention. This study fills a critical gap in Indian psychiatric settings by assessing the impact of structured de-escalation training, aiming to create a safer, therapeutic environment for both patients and healthcare workers. |