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CTRI Number  CTRI/2024/01/060993 [Registered on: 01/01/2024] Trial Registered Prospectively
Last Modified On: 07/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Nursing]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluate the effectiveness of parenthood preparation protocol on perception, knowledge and practice of infant care among primimothers. 
Scientific Title of Study   Evaluate the effectiveness of parenthood preparation protocol on perception, knowledge and practice of infant care among primimothers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Siji T Jose 
Designation  Professor 
Affiliation  Bishop Benziger College of Nursing 
Address  Child Health Nursing department MGM Muthoot College of Nursing Kozhencherry Pathanamthitta district Kerala
Sastri Junction Kollam Kerala
Kollam
KERALA
689641
India 
Phone  9645465567  
Fax    
Email  josesiji651@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Anoopa KR 
Designation  Principal 
Affiliation  Bishop Benziger College of Nursing 
Address  Bishop Benziger college of nursing Sastri Junction Kollam
SIMET College of Nursing Konny Pathanamthitta Kerala
Pathanamthitta
KERALA
691001
India 
Phone  8281302895  
Fax    
Email  anoopasuresh@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Prof Dr Anoopa KR 
Designation  Principal 
Affiliation  Bishop Benziger College of Nursing 
Address  Bishop Benziger college of nursing Sastri Junction Kollam
SIMET College of Nursing Konny Pathanamthitta Kerala
Pathanamthitta
KERALA
691001
India 
Phone  8281302895  
Fax    
Email  anoopasuresh@yahoo.co.in  
 
Source of Monetary or Material Support  
Government hospitals of Pathanamthitta district 
 
Primary Sponsor  
Name  Siji T Jose 
Address  Puthookallel house, Karimbanakuzhy Pathanamthitta Kerala 
Type of Sponsor  Other [Self] 
 
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 
Siji T Jose  Government hospitals of Pathanamthitta district   Taluk hospital, Kozhencherry
Pathanamthitta
KERALA 		 9645465567

josesiji651@gmail.com 
Siji T Jose  Government hospitals of Pathanamthitta district   Taluk hospital, Thiruvalla
Pathanamthitta
KERALA 		 9645465567

josesiji651@gmail.com 
SijiT Jose  Government hospitals of Pathanamthitta district   General hospital, Adoor
Pathanamthitta
KERALA 		 9645465567

josesiji651@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HolyCrossHospital  No Objection Certificate 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primimothers  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Parenthood preparation protocol   Pre-test score on perception and knowledge will be obtained from experimental group. Parenthood preparation protocol will be given to the experimental group primimothers (34-36 week of gestation) with appropriate AV Aids. From experimental group, on 3rd postnatal day, first post-test for perception, knowledge and reported practice scores will be obtained. On 6th week, second post-test on perception, knowledge and reported practice scores will be obtained. During this visit booklet will be given for reinforcement. On 10th week, third post-test on perception, knowledge and reported practice will be obtained.  
Comparator Agent  Routine care  Routine care as per hospital policy. Parenthood preparation protocol booklet on 10th week. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  -Adult Primimothers who are in the age of 20-40 years will be included in the study
-These Primimothers will be attending the selected departments for their routine checkups
-Primimothers should have children 0-6 months of age
-Primimothers who can understand and communicate in malayalam language will be included
-Primimothers who are willing to share relevant experiences, issues and needs of newborn care
-Primimothers who stay with newborn for 3 days in postnatal ward
-Primimothers who stay with newborn for 3 days in postnatal ward.
-Primimothers who will be available along with babies for next three visits for immunization at same hospital. 
 
ExclusionCriteria 
Details  Primimothers between 20-40 years of age are in following criteria are excluded in the study
-Mothers who had psychiatric disorder before conception will be excluded
-Mothers who are presently on any drug therapy
-Mothers of child with chronic disease or life threatening disease
-Infants with developmental delay, congenital anomalies, systematic diseases 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
to ascertain the effect of parenthood preparation on primimothers’ perception, knowledge and practice in infant care with a view to utilize the findings in formulating protocols to improve infant care practices.  3rd postnatal day, 6 week and 10 week  
 
Secondary Outcome  
Outcome  TimePoints 
effectiveness of parenthood preparation protocol based on the data extracted from the qualitative phase and literature review  upto 10 weeks  
 
Target Sample Size   Total Sample Size="192"
Sample Size from India="192" 
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   Phase 1/ Phase 2 
Date of First Enrollment (India)   08/01/2024 
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="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 31-08-2024 and end date provided 31-08-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 Researcher would like to evaluate the effectiveness of parethood protocol on perception, knowledge and practice among primimother. Study will be done as mixed methodology.

The qualitative data will be collected through in-depth interview using structured interview log till attains the data saturation. Primimothers, neonatologists & nursing staffs will be included in in-depth interview. The validity of the interview log will be established. The data will be analysed using codes, subthemes and themes. On next phase

Pre-test score on perception and knowledge will be obtained from both experimental group and control group. Parenthood preparation protocol will be given to the experimental group primimothers (34-36 week of gestation) with appropriate AV Aids. From experimental group, on 3rd postnatal day, first post-test for perception, knowledge and reported practice scores will be obtained. On 6th week, second post-test on perception, knowledge and reported practice scores will be obtained. During this visit booklet will be given for reinforcement. On 10th week, third post-test on perception, knowledge and reported practice will be obtained. Post-test from control group will be obtained simultaneously on 3rd day, 6th week and 10th week after routine care. Objectives are 1.      To explore the perception, knowledge and practices of primimothers on infant care.1.      To assess the perception on infant care among primimothers.

2.      To assess the knowledge on infant care among primimothers.

3.      To assess the practices on infant care among primimothers.

4.      To determine the effect of parenthood preparation protocol on perception towards infant care among primimothers.

5.      To determine the effect of parenthood preparation protocol on knowledge towards infant care among primimothers.

6.      To determine the effect of parenthood preparation protocol on practice towards infant care among primimothers.

7.      To find the association between perception among primimothers on infant care with selected demographic variables.

8.      To find the association between knowledge among primimothers on infant care with selected demographic variables.

9.      To find the association between practice among primimothers on infant care with selected demographic variables


 
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