| 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
|
|
|
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
|
|
|
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 nurseāled 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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