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CTRI Number  CTRI/2024/04/065797 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 16/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Competency Enhancement Program]  
Study Design  Other 
Public Title of Study   Competency Enhancement Program on Fetal well-being 
Scientific Title of Study   A study to evaluate the effectiveness of Competency Enhancement Program on Fetal well-being in terms of knowledge, skills and clinical decision-making ability among nursing students of selected colleges of Ambala, Haryana. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ramanjit Kaur 
Designation  PG Nursing Student 
Affiliation  M.M College of Nursing, Maharishi Markandeshwar(Deemed to be university) Mullana, Ambala 
Address  Obstetrics and Gynecology department M.M COLLEGE OF NURSING MULLANA,AMBALA HARYANA India

Ambala
HARYANA
133207
India 
Phone  8288910425  
Fax    
Email  ramansandhu2408@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ms Simarjeet Kaur 
Designation  Associate professor  
Affiliation  M.M College of Nursing, Maharishi Markandeshwar(Deemed to be university) Mullana, Ambala 
Address  Obstetrics and Gynecology department M.M COLLEGE OF NURSING MULLANA,AMBALA HARYANA India

Ambala
HARYANA
133207
India 
Phone  8059991569  
Fax    
Email  coolsimar89@mmumullana.org  
 
Details of Contact Person
Public Query
 
Name  Ramanjit Kaur 
Designation  PG Nursing Student 
Affiliation  M.M College of Nursing, Maharishi Markandeshwar(Deemed to be university) Mullana, Ambala 
Address  Obstetrics and Gynecology department M.M COLLEGE OF NURSING MULLANA,AMBALA HARYANA India

Ambala
HARYANA
133207
India 
Phone  8288910425  
Fax    
Email  ramansandhu2408@gmail.com  
 
Source of Monetary or Material Support  
M.M College of Nursing, Mahrishi markandeshwar deemed to be university Mullana, Ambala, Haryana, India -133207 
 
Primary Sponsor  
Name  Maharishi Markandeshwar Deemed University 
Address  M.M College of Nursing, Maharishi markandeshwar deemed to be university, Mullana, Ambala, Haryana, India-133207 
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 
Ramanjit kaur  Maharishi Markandeshwar Deemed to be University  Obstetrics and gynecology department, MMIMSR&Hospital;Room no.209,210 M.M.COLLEGE OF NURSING MULLANA
Ambala
HARYANA 
8288910425

ramansandhu2408@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical committee(IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Nursing students 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Competency Enhancement Program  Competency Enhancement Program on fetal well-being in terms of knowledge, skills and clinical decision-making ability among nursing students is a 2hours session including teaching and demonstrations 
Comparator Agent  No intervention given to comparison group  No intervention given to comparator group 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  The study will include nursing students who are: Students of B.sc Nursing 4th year available at the time of data collection 
 
ExclusionCriteria 
Details  The study will exclude nursing students who are: Absent for post test or intervention 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Knowledge, skills and clinical decision-making ability   2 months 
 
Secondary Outcome  
Outcome  TimePoints 
Satisfaction regarding the intervention among nursing students  1 month 10 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   03/05/2024 
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="0"
Months="1"
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   A study to evaluate the effectiveness of Competency Enhancement Program on Fetal well-being in terms of knowledge, skills and clinical decision-making ability among nursing students of selected colleges of Ambala, Haryana. 
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