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CTRI Number  CTRI/2024/09/073316 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 23/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [AI assisted simulation]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of artifical intellignece assisted simulation on breast self examination 
Scientific Title of Study   Pilot testing of the efficacy of artifical intelligence assisted simulation on breast self examination at presrvice level in a selected tertiary care instittution of the Eastrn part of India: an open labelled randomized controlled trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
New ID  NIL 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Poonam Joshi 
Designation  Professor cum Principal 
Affiliation  AIIMS KALYANI 
Address  College of Nursing, 4th Floor, Room NO. 401, AIIMS KALYANI, Basantapur, Nadia District
College of Nursing, 4th Floor, Room NO. 401, AIIMS KALYANI, Basantapur, Nadia District
Nadia
WEST BENGAL
741245
India 
Phone  9818039744  
Fax    
Email  poonam.nursing@aiimskalyani.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Poonam Joshi 
Designation  Professor cum Principal 
Affiliation  Professor cum Principal 
Address  College of Nursing, AIIMS KALYANI, Basantapur, Nadia District

Nadia
WEST BENGAL
741245
India 
Phone  9818039744  
Fax    
Email  poonam.nursing@aiimskalyani.edu.in  
 
Details of Contact Person
Public Query  
Name  Poonam Joshi 
Designation  Professor cum Principal 
Affiliation  AIIMS KALYANI 
Address  College of Nursing, 4th Floor, Room No. 401, AIIMS KALYANI, Basantapur, Nadia District
College of Nursing, 4th Floor, Room No. 401, AIIMS KALYANI, Basantapur, Nadia District
Nadia
WEST BENGAL
741245
India 
Phone  9818039744  
Fax    
Email  poonam.nursing@aiimskalyani.edu.in  
 
Source of Monetary or Material Support  
AIIMS Kalyani 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Research institution and hospital 
 
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 Poonam Joshi  AIIMS Kalyani  College of Nursing, COnference room, first floor, AIIMS KALYANI, Basantapur, Nadia District
Nadia
WEST BENGAL 		 9818039744
9818039744
poonam.nursing@aiimskalyani.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Kalyani  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 
Intervention  AI assisted simulation   AI assisted simulation will be used to to teach breast self examinaation at preservice level 
Comparator Agent  Conventional Simulation  simulation method will be used to teach breast self examination to the comparator group 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  All females enrolled in MBBS, or Nursing, or paramedical courses, age more than 18 years, Can understand Hindi or English  
 
ExclusionCriteria 
Details  Not willing to participate  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
knowledge scores  baseline, immediately after intervention and at 8 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
anxiety, satisfaction and confidence levels  baseline, immediately after intervention and at 8 weeks  
 
Target Sample Size   Total Sample Size="185"
Sample Size from India="185" 
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)   01/11/2024 
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 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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [poonam.nursing@aiimskalyani.edu.in].

  6. For how long will this data be available start date provided 20-11-2024 and end date provided 20-11-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   In this RCT, we compare AI-assisted Breast self-examination with the traditional method of breast self-examination using a simulation technique. Since it is a new topic for them, we will assess the knowledge as a primary outcome of the study and the secondary outcome variables are skills, satisfaction and confidence scale. 
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