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CTRI Number  CTRI/2025/10/095619 [Registered on: 06/10/2025] Trial Registered Prospectively
Last Modified On: 04/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Nurse-Led supportive educational programme]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Impact of nurse given health education programme on knowledge and practice regarding anemia among pregnant women 
Scientific Title of Study   Impact Of Nurse-Led Intervention Programme On Knowledge And Practice Regarding Anemia In Pregnancy Among Antenatal Mothers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sangeet Sarita Sur 
Designation  PhD Research Scholar 
Affiliation  Teerthanker Mahaveer College of Nursing 
Address  Dr M Jasline Department of Medical Surgical Nursing Teerthanker Mahaveer College of Nursing Teerthanker Mahaveer University Delhi Road Moradabad Uttar Pradesh 244001 India

Moradabad
UTTAR PRADESH
244001
India 
Phone  9439193311  
Fax    
Email  sangeet.scholar@tmu.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr M Jasline 
Designation  Professor and Supervisor 
Affiliation  Teerthanker Mahaveer College of Nursing 
Address  Department of Medical Surgical Nursing Teerthanker Mahaveer College of Nursing Teerthanker Mahaveer University Delhi Road Moradabad Uttar Pradesh 244001 India

Moradabad
UTTAR PRADESH
244001
India 
Phone  8279816167  
Fax    
Email  drjaslinejohn.msn@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Dr M Jasline 
Designation  Professor and Supervisor 
Affiliation  Teerthanker Mahaveer College of Nursing 
Address  Department of Medical Surgical Nursing Teerthanker Mahaveer College of Nursing Teerthanker Mahaveer University Delhi Road Moradabad Uttar Pradesh 244001 India

Moradabad
UTTAR PRADESH
244001
India 
Phone  8279816167  
Fax    
Email  drjaslinejohn.msn@gmail.com  
 
Source of Monetary or Material Support  
Teerthanker Mahaveer College of Nursing Teerthanker Mahaveer University Delhi Road Moradabad Uttar Pradesh India 244001 
 
Primary Sponsor  
Name  Sangeet Sarita Sur 
Address  Teerthanker Mahaveer College of Nursing Teerthanker Mahaveer University Delhi Road Moradabad Uttar Pradesh 244001 
Type of Sponsor  Other [Private University with Research] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rabindranath Singh  Dukura Community Health Centre  Medical Officer IC Dukura CHC Dukura, Mayurbhnaj, Odisha, 757075, India
Mayurbhanj
ORISSA 
9439995896

moicdukurachc456@gmail.com 
Dr Maheswar Majhi  KC Pur Community Health Centre  Medical Officer IC KC Pur CHC Krishna Chandra Pur, Mayurbhanj, Odisha, 757029, India
Mayurbhanj
ORISSA 
9439997501

bpmukcpur@gmail.com 
Dr Baijayanti Singh  Kuliana Community Health Centre  Medical Officer IC Kuliana CHC Kuliana, Mayurbhanj, Odisha, 757030, India
Mayurbhanj
ORISSA 
9439995853

moickulianachc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
TEERTHANKER MAHAVEER DENTAL COLLEGE AND RESEARCH CENTRE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Antenatal Mother with Anemia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CONTROL GROUP 2  STRUCTURED TEACHING PROGRAMME NOT TO BE PROVIDED 
Intervention  EXPERIMENTAL GROUP 1  STRUCTURED TEACHING PROGRAMME FOR 2 HOUR 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  1.Mothers with antenatal registration, above 18 years of age
2.Both primipara and multiparous women
3.Antenatal mother with second trimester (gestational age 13 to 26 weeks)
4.Antenatal mother having hemoglobin level less than 11gm/dL
5.Antenatal mothers willing to participate in the study
6.Available during the period of data collection
7.Able to communicate Ol chiki/Odia /Hindi/ English
 
 
ExclusionCriteria 
Details  1.Not willing to participate
2.Not available during the period of data collection
3.Mothers who are not physically and mentally healthy
4.Below the age of 18 years
5.Medical or obstetric complication during current pregnancy
6.Any other disease that interferes with metabolism of iron
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Improvement in maternal health outcomes.
2.Empowerment of Antenatal mothers.
3.Strengthening of nursing practice.
4.Guiding for the future course of Research.
5.Improved Health-Seeking behaviour.
6.Community health promotion.
 
1.2 WEEKS
2.4 WEEKS 
 
Secondary Outcome  
Outcome  TimePoints 
1.Improvement in maternal knowledge & practice of health outcome regarding prevention of anemia through out pregnancy
2.Reduce MMR & IMR caused by anemia  
34 weeks 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   23/10/2025 
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 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 - NO
Brief Summary  
Objectives
1.To assess the knowledge levels regarding anemia in pregnancy among antenatal mothers before and after the implementation of a nurse-led intervention program
2.To assess the practice levels regarding anemia in pregnancy among antenatal mothers before and after the implementation of a nurse-led intervention program
3.To evaluate the impact of the nurse-led intervention programme in improving knowledge regarding anemia in pregnancy.
4.To evaluate the impact of the nurse-led intervention programme in improving practice level regarding anemia in pregnancy.
5.To determine the correlation between knowledge and practice level regarding anemia in pregnancy among antenatal mothers.65.To assess the association between knowledge and practice level with selected demographic variables of antenatal mothers.
7.To determine the impact of nurse–led intervention programme in improving overall anemia management by assessing hemoglobin level through post intervention follow up consultation
Assumption
1.Antenatal mothers have in-adequate knowledge and improper practice regarding anemia in pregnancy.
2.A nurse-led intervention programme can help the ANC mothers to improve their knowledge and practice regarding anemia effectively.
3.It is assumed that antenatal mother will honestly respond to the tool.
4.The nurse-led intervention will be acceptable by the antenatal mother to improve their knowledge and practice level
Research design
1.Research design is basically a master plan which postulating the method and procedures for collecting the needed information followed by analyzing the gathered information in a research study.A quasi-experimental research design is adopted by researcher to gather proper information about the fact taken as objective of the study.
2.Non randomized design is used for the present study.
 
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