| 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
|
|
|
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
|
|
|
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
|
|
|
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. |