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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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