| CTRI Number |
CTRI/2025/03/083387 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
14/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
women who is pregnant for first time is always having doubts regarding pregnancy,labour processes,postnatal care..the study will help the primi mothers to get enough knowledge about child birth so that they can understand the changes and hence get a positive delivery outcomes |
|
Scientific Title of Study
|
Effectiveness of Comprehensive Nursing Interventional Package on Knowledge and Attitude Regarding Birth Preparedness and its labor outcomes experienced by primi 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 |
Prof Vijimol |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Department of Obstetrics & Gynaecology,Room no 302,Teerthanker Mahaveer College of Nursing,TMU, Moradabad Uttar Pradesh
Moradabad Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
08894126177 |
| Fax |
|
| Email |
vijimolg.nursing@tmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sapna Singh |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Department of Child Health Nursing,Room no 101,Teerthanker Mahaveer College of Nursing, TMU, Moradabad Uttar Pradesh
Moradabad Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9877550108 |
| Fax |
|
| Email |
drsapna.nursing@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Vijimol |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Department of Obstetrics & Gynaecology,Room no:302,Teerthanker Mahaveer College of Nursing,TMU, Moradabad Uttar Pradesh
Moradabad Uttar Pradesh
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
08894126177 |
| Fax |
|
| Email |
vijimolg.nursing@tmu.ac.in |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer College of Nursing,Moradabad,Uttar Pradesh,UP,India-244001 |
|
|
Primary Sponsor
|
| Name |
Prof Vijimol |
| Address |
c-905,palm greens appartment,super tech,Moradabad,Uttar Pradesh. |
| 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 |
| DrAstha Lalwani |
Teerthanker Mahaveer Hospital |
Department of Obstetrics & Gynaecology.Room number 26 Teerthanker Mahaveer Hospital ,Moradabad,Uttar
Pradesh,India-244001
Moradabad
UTTAR PRADESH |
9927655238
asthalalwanirastogi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Teerthanker Mahaveer Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Comprehensive Nursing Interventional Package |
birth preparedness programme which includes teaching regarding exercises for easy birth, danger signs, labour process and positions, postnatal and newborn care and emotional support with the help of PPTS, charts, videos etc for experimental group.Duration for the intervention is 4 weeks |
| Intervention |
Comprehensive Nursing Interventional Package |
birth preparedness programme which includes teaching regarding exercises for easy birth, danger signs, labour process and positions, postnatal and newborn care and emotional support with the help of PPTS, charts, videos etc for control group after the data collection.
Duration for the intervention is 4 weeks. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Primi mothers in third trimester
2. Primi mothers admitted in hospital
3. Primi mothers who understands Hindi or English
|
|
| ExclusionCriteria |
| Details |
1. Primi mothers who are not willing to participate
2. Primi mothers who were unable to hear and speak
3. Primi mothers with high risk and severely ill.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comprehensive Nursing Interventional Package will enhance the knowledge and attitude regarding birth preparedness of primi mothers and will help them to achieve a positive labour outcome |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To create awareness among primi antenatal mothers
2.To make the labour outcome with positve experiences |
1 week |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
04/04/2025 |
| 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 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
|
Effectiveness of Comprehensive Nursing
Interventional Package on Knowledge and
Attitude Regarding Birth Preparedness and its labour outcomes
experienced by primi mothers Objectives 1. To assess the Knowledge and
Attitude Regarding Birth Preparedness of
primi mothers. 2.
To assess the effectiveness of Comprehensive Nursing Interventional Package on
Knowledge and Attitude Regarding Birth Preparedness. 3.
To find out the labour outcomes experienced by primi mothers
4.
To find out the association between pre-test knowledge and attitude among primi mothers with their selected
demographic profile. Hypothesis
H1:There is a significant difference between mean
pretest and posttest knowledge score of primi mothers on Knowledge and Attitude
regarding Birth Preparedness P<0.05 level.
H2:There is a significant association between posttest
knowledge score of primi mothers on Knowledge and Attitude regarding
Birth Preparedness on labour outcome at P<0.05 level .
H3: There is a significant association between
pretest knowledge score with selected demographic variables of at P<0.05
level.
|