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CTRI Number  CTRI/2024/02/062395 [Registered on: 07/02/2024] Trial Registered Prospectively
Last Modified On: 29/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Forensic training of Nurses and Doctors in CHC and PHC.  
Scientific Title of Study   Study to access the effectiveness of forensic training of medical and nursing officers of urban and rural health centers on identification of injuries and medico-legal evidence collection in sexual assault and domestic violence cases in Karnataka: A Randomized controlled trial.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mr Renjulal Yesodharan  
Designation  Assistant Professor Senior Scale  
Affiliation  Manipal college of Nursing, Manipal  
Address  Room No 601 A Manipal college of Nursing, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8095900592  
Fax    
Email  renjulal.y@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Mr Renjulal Yesodharan  
Designation  Assistant Professor Senior Scale  
Affiliation  Manipal college of Nursing, Manipal  
Address  Room No 601 A Manipal college of Nursing, Manipal

Udupi
KARNATAKA
576104
India 
Phone  8095900592  
Fax    
Email  renjulal.y@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Tessy Treesa Jose  
Designation  Associate Dean 
Affiliation  Manipal college of Nursing, Manipal  
Address  Manipal College of Nursing, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9844152459  
Fax    
Email  tessy.j@manipal.edu  
 
Source of Monetary or Material Support  
Indian Council of Medical Research V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India Ph: 91-11-26588895 / 91-11-26588980, 91-11-26589794 / 91-11-26589336, 91-11-26588707 Fax: 91-11-26588662 Email: icmrhqds@sansad.nic.in 
 
Primary Sponsor  
Name  Indian Council of Medical Research  
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
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 Vinod C Nayak   Manipal college of Nursing  Room no 601 Department of Psychiatric Nursing Manipal college of Nursing, Manipal
Udupi
KARNATAKA 		 9845240393

vinod.nayak@manipal.edu 
 
Details of Ethics Committee  
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Not applicable 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Forensic Training on identification of injuries and medico legal evidence collection   duration of the intervention is around 40 hours and for a period of 5 days  
Comparator Agent  Regular in-service training   only once  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Medical and Nursing officers working in Community health centers and primary health centers of Udupi and Dakshina Kannada District  
 
ExclusionCriteria 
Details  Participants who are not willing to participate  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
knowledge assessed using KQSANE   1 month  
 
Secondary Outcome  
Outcome  TimePoints 
Skill assessed using checklist   1 month  
 
Target Sample Size   Total Sample Size="360"
Sample Size from India="360" 
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)   15/02/2024 
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="2"
Months="0"
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   Gender based violence, one of the key indicators in the National Family Health Survey (NFHS-5) 2020-21 and the results showed 29.3% of the married women in the age group of 18-49 are experiencing spousal violence (sexual and physical). Meanwhile, 1.5% of the women experienced sexual violence by the age of 18 years. These figures are noticeable when seeing the current population of India. As per the crime Records Bureau of India, latest report 10 lakhs crimes are against the body of the individuals. These crime required prompt forensic enquiry and medico-legal evidence collection. 


The current study focuses on the forensic training of medical and nursing officers to improve the skill and knowledge in identifying and collecting medico-legal evidences from victims of sexual assault and  domestic violence. the research also focuses on developing an in-service curriculum through a three stage Delphi method for the medical and nursing officers for improving the medico- legal competencies. 
 
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