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CTRI Number  CTRI/2021/02/031009 [Registered on: 04/02/2021] Trial Registered Prospectively
Last Modified On: 03/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A psychological first aid training for knowledge and self-efficacy of nurses 
Scientific Title of Study   Effect of psychological first aid training on knowledge and self efficacy of nursing officers: A randomized control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Rathish Nair 
Designation  Assistant professor, College of Nursing 
Affiliation  All India Institute of Medical Sciences, Patna 
Address  Principals Office, College of Nursing, Department of Nursing, College of Nursing building, AIIMS Patna campus, Phulwarishariff

Patna
BIHAR
801507
India 
Phone  7766905578  
Fax    
Email  drrathishr@aiimspatna.org  
 
Details of Contact Person
Scientific Query  
Name  Mr Rathish Nair 
Designation  Assistant professor, College of Nursing 
Affiliation  All India Institute of Medical Sciences, Patna 
Address  Principals Office, College of Nursing, Department of Nursing, College of Nursing building, AIIMS Patna campus, Phulwarishariff

Patna
BIHAR
801507
India 
Phone  7766905578  
Fax    
Email  drrathishr@aiimspatna.org  
 
Details of Contact Person
Public Query  
Name  Mr Rathish Nair 
Designation  Assistant professor, College of Nursing 
Affiliation  All India Institute of Medical Sciences, Patna 
Address  Principals Office, College of Nursing, Department of Nursing, College of Nursing building, AIIMS Patna campus, Phulwarishariff

Patna
BIHAR
801507
India 
Phone  7766905578  
Fax    
Email  drrathishr@aiimspatna.org  
 
Source of Monetary or Material Support  
Mr. Rathish Nair, Assistant Professor & Principal in charge, Principals Office, College of Nursing, Department of Nursing, College of Nursing building, AIIMS Patna campus, Phulwarishariff 
 
Primary Sponsor  
Name  College of Nursing 
Address  AIIMS Patna, Phulwarishriff, Patna, Bihar - 801507 
Type of Sponsor  Other [Government Nursing College] 
 
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 
Mr Rathish Nair  College of Nursing, AIIMS Patna  College of Nursing building, AIIMS PATNA campus, Phulwarishariff
Patna
BIHAR 		 7766905578

drrathishr@aiimspatna.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee, AIIMS Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Human Volunteers for the study are the nursing officers working in AIIMS Patna. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No Specific intervention  The control arm will not be provided with any intervention 
Intervention  Training on psychological first aid  The nursing officers would trained on the concepts of psychological first aid, warning signs of common psychological issues, techniques to facilitate communication and self care, along with related group activities. It would be a 8 hour training program provided by the investigators, in classroom setting. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Nursing officers working at All India Institute of Medical Sciences, Patna
2. Nursing officers who are willing to give informed consent 
 
ExclusionCriteria 
Details  1. Nursing officers who have already attended training on psychological first aid 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Self Efficacy  Baseline, first day and 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Knowledge  Baseline, first day and two weeks 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   15/02/2021 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a randomized control trial planned to enhance the knowledge regarding Psychological first aid and Self-efficacy by providing psychological first aid training to the nursing officers selected and allocated randomly. The nursing officers had been working in different wards and ICUs of a central government medical college hospital of national importance, which has been a dedicated COVID hospital for last 10 months. The training would include the meaning and concepts of psychological first aid, its purpose and importance along with techniques for facilitating communication with patients and warning signs of common psychological issues like depression, aggression and anxiety. The variables will be assessed by WHO knowledge questionaire and self efficacy scale. The control group will be assessed initially, and intervention would follow so as to avoid any contamination. The trial is expected to be over in a month. 
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