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CTRI Number  CTRI/2022/12/047834 [Registered on: 02/12/2022] Trial Registered Prospectively
Last Modified On: 27/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Video assisted teaching]  
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of video assisted teaching on knowledge regarding risk factors, prevention and management of Varicose veins among Security guards of AIIMS, New Delhi 
Scientific Title of Study   A study to assess the effectiveness of video assisted teaching on knowledge regarding risk factors, prevention and management of varicose veins among security guards of AIIMS, New Delhi  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shubham Gaur 
Designation  M.Sc Nursing Student 
Affiliation  AIIMS, New Delhi 
Address  College Of Nursing AIIMS New Delhi

South
DELHI
110029
India 
Phone  08741050978  
Fax    
Email  subhamgaur7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ujjwal Dahiya 
Designation  Associate Professor 
Affiliation  AIIMS, New Delhi 
Address  Critical Care, College Of Nursing AIIMS, New Delhi

South West
DELHI
110029
India 
Phone  9899770134  
Fax    
Email  ujjwaldahiya3@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shubham Gaur 
Designation  M.Sc Nursing Student 
Affiliation  AIIMS, New Delhi 
Address  Critical Care, College Of Nursing AIIMS, New Delhi

South
DELHI
110029
India 
Phone  08741050978  
Fax    
Email  subhamgaur7@gmail.com  
 
Source of Monetary or Material Support  
AIIMS New Delhi 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Critical Care, College of Nursing AIIMS New Delhi 
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 
Shubham gaur  AIIMS New Delhi  Security guards office, AIIMS , New Delhi
South
DELHI 		 08741050978

subhamgaur7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICAL COMMITTEE FOR POAT GRADUATE RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  Video assisted teaching programme  the video is for a duration of 7 minutes 21 seconds . it is in hindi language. it is regarding the knowledge related to risk factor, prevention and management of varicose veins. the playback audio is given by the investigator.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Security guards must have completed atleast one year of experience in AIIMS.
2. Security guards between C1 to C3 score using CEAP Screening tool. 
 
ExclusionCriteria 
Details  1. Security guards who are not willing to participate.
2. Security guards having C0 score or more than C3 score using CEAP Screening tool. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of video assisted teaching regarding risk factors, prevention and management of varicose veins among security guards of AIIMS, New Delhi  Baseline to 4 weeks after video assisted teaching programme 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the screening for varicose vein among security guards of AIIMS, Delhi.  baseline to 3 months 
To determine association of level of knowledge regarding prevention and management of varicose among security guards with their selected demographic variables.  baseline to 30 days 
To assess the improvement in symptoms using CEAP scoring after 30 days of intervention among the security guards.  baseline to 30 days 
 
Target Sample Size   Total Sample Size="154"
Sample Size from India="154" 
Final Enrollment numbers achieved (Total)= "2100"
Final Enrollment numbers achieved (India)="154" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/12/2022 
Date of Study Completion (India) 15/12/2022 
Date of First Enrollment (Global)  02/12/2022 
Date of Study Completion (Global) 15/12/2022 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   Publish after june 2023 
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-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  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 [subhamgaur7@gmail.com].

  6. For how long will this data be available start date provided 10-01-2023 and end date provided 03-03-2023?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Primary objective:

·       To evaluate the effectiveness of video assisted teaching programme on knowledge regarding prevention and management of varicose vein

 

Secondary objective:

·       To assess the screening for varicose vein among security guards of AIIMS, Delhi.

·       To determine association of level of knowledge regarding prevention and management of varicose among security guards with their selected demographic variables.

·       To assess the improvement in symptoms using CEAP scoring after 30 days of intervention among the security guards.

 
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