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CTRI Number  CTRI/2024/03/064222 [Registered on: 15/03/2024] Trial Registered Prospectively
Last Modified On: 27/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Screening 
Study Design  Other 
Public Title of Study   To explore different family planning techniques utilized by people residing in the community. 
Scientific Title of Study   Effectiveness of Six Sigma Methodology on Adoption of Family Planning Methods 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NEHA BARARI 
Designation  ASSISTANT PROFESSOR 
Affiliation  SHARDA UNIVERSITY 
Address  Flat no. 3121, tower 3, CRC Sublimis, Sector 01, Greater Noida, UP. 201301
Sharda school of nursing science and research, Block 4, Ground Floor, Room No.007, Sharda University, Greater Noida, UP, 201310, India
Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9877550251  
Fax  0  
Email  neha.barari@sharda.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  DEEPAK SETHI 
Designation  DEAN  
Affiliation  SON Noida International University 
Address  Plot No. 1, Sector-17A, Yamuna Expressway, (Opp. F1 Track), Gautam Budh Nagar, Uttar Pradesh 203201 Department Nursing Ground floor Dean office Room no.001
NA
Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9988963832  
Fax  0  
Email  dir.son@niu.edu.in  
 
Details of Contact Person
Public Query
 
Name  DEEPAK SETHI 
Designation  DEAN  
Affiliation  SON Noida International University 
Address  Plot No. 1, Sector-17A, Yamuna Expressway, (Opp. F1 Track), Gautam Budh Nagar, Uttar Pradesh 203201 Department Nursing Ground floor dean office Room no.001
NA
Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9988963832  
Fax  0  
Email  dir.son@niu.edu.in  
 
Source of Monetary or Material Support  
Sharda school of nursing science and research, Block 4, Ground Floor, Room No.007, Sharda University, Greater Noida, UP, 201310, India 
 
Primary Sponsor  
Name  NEHA BARARI 
Address  Sharda school of nursing science and research sharda university 
Type of Sponsor  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 
NEHA BARARI  Village Panchayatan  Village Panchayatan, Dankaur Block, Gautam Buddha Nagar District, Uttar Pradesh, 203202
Gautam Buddha Nagar
UTTAR PRADESH 
09877550251
0
neha.barari@sharda.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE, SCHOOL OF MEDICAL SCIENCES RESEARCH, SHARDA UNIVERSITY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  reproductive age group people 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  adopting family planning methods by using six sigma methodology  PHASE I (Use Define phase of DMAIC Cycle) Interview method for identification of causes. 2.Thematic analysis PHASE II (Use of Measure, Analyse, Improve, Control Phase of DMAIC Cycle) MEASURE PHASE Measure cognizance, attitude and practice of FPM. Collect pre-interventional data by using tool (Semi-structure questionnaire, checklist and Likert scale.) ANALYSE PHASE Root cause analysis of pre-interventional data and qualitative data. IMPROVE PHASE Intervention (teaching) Collect Post-interventional data after 14 days. CONTROL PHASE After 3 months follow up for the same. 
Comparator Agent  Routine family planning methods used by reproductive age group people.  pre-test post test  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Reproductive age group.
Who are available and willing to participate in the study during data collection
Who can understand Hindi or English language
 
 
ExclusionCriteria 
Details  Females under menopause 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
EFFECTIVE USE OF FAMILY PLANNING METHODS  After 14day post test
after 3 months follow up 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   25/03/2024 
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="1"
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  

         Family planning is a method and standard of living adopted by the couples by their own choice that is based on knowledge and attitude regarding various methods of contraception. As per the WHO, almost 25% of maternal mortality can be reduced in developing countries by adopting safe family planning methods and preventing unwanted pregnancies, unsafe abortions and protection against STIs etc. Utilization or practice of contraceptive methods are affected by some barriers those are present in our society and in our surroundings only. There is a clear need to investigate the hurdles that prevent family planning approaches from being accepted and used. Health outcomes, procedure and standard of healthcare, budgets, and staff and patient’s happiness have all been linked to Lean and Six Sigma in healthcare. Lean and Six Sigma is described as "a business strategy and methodology that improves performance levels, resulting in increased satisfaction of customers and improved bottom-line results. As Lean Six Sigma training provides a set of team-building tools that help individuals to collaborate, engage and negotiate with a variety of disciplines across the organization in pursuit of change by using this methodology we can identify the root causes and find out the solution. 

 
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