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CTRI Number  CTRI/2024/04/065807 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 02/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Assess the effect of a progrmme called comprehensive baby bond stimulation programme administered for the antenatal mothers from 26 weeks of gestation on antenatal bonding( bonding with the fetus) and postnatal bonding (bonding with newborn) and on mental health 
Scientific Title of Study   Assess the Effect of comprehensive baby bond stimulation programme on bonding and mental health among mothers: A mixed method study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bindu K V Sr Godwin 
Designation  Asso.Professor 
Affiliation  Jubilee Mission College of Nursing 
Address  Jubilee Mission College of Nursing Department of obstetrics and gynaecological nursing St Thomas Block Kachery, Thrissur Kerala

Thrissur
KERALA
680005
India 
Phone  8592989279  
Fax    
Email  godwinchf@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sr Tresa Anto 
Designation  Vice Principal 
Affiliation  Jubilee Mission College of Nursing  
Address  Jubilee Mission College of Nursing Department of child health nursing st. Thomas Block Kachery, Thrissur Kerala

Thrissur
KERALA
680005
India 
Phone  8592989279  
Fax    
Email  srtresaanto@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ms Justy Joy 
Designation  Asst. Professor 
Affiliation  jubilee mission college of nursing 
Address  Jubilee Mission college of nursing Department of obstetrics and gynaecologic nursing St Thomas block Thrissur

Thrissur
KERALA
680005
India 
Phone  8086503902  
Fax    
Email  justycj@gmail.com  
 
Source of Monetary or Material Support  
Jubilee Mission Medical College hospital Thrissur 68005 Kerala 
 
Primary Sponsor  
Name  Nil 
Address  No Sponsors since it is a the part of PhD programme  
Type of Sponsor  Other [Academic Study] 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Bindu K V Sr Godwin  Jubilee Mission Medical college Hospital  JUbilee Mission Medical college hospital Department of obstetrics and Gynaecology St Thomas block (Ground floor)
Thrissur
KERALA 
8592989279

godwinchf@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics CommitteeJubilee Mission Medical College and research institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  baby bond stimulation programme and baby bond and mental health  after providing baby bond stimulation programme assess the bonding and mental health during antenatal period and postnatal period 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.Primi gravida mothers who are registered in JMMC& RI
2.Primi gravida who are in third trimester (26-28 weeks)
3.Who know English or Malayalam
Qualitative strand: Phase II
4.Mothers who are Information rich cases
5.Mothers who shows Maximum variant characteristics 
 
ExclusionCriteria 
Details  1.Antenatal mothers who has pregnancy related complication
2.Mothers with history of mental disorders
Qualitative strand: Phase II
3.Mothers who are poor in communication skil 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comprehensive Baby bond stimulation programme improves bonding   1month, 2 month after the intervention and 4 weeks of puerperium 
 
Secondary Outcome  
Outcome  TimePoints 
Good bonding will improve the mental health   1month, 2 month after the intervention and 4 weeks of puerperium 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/08/2024 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [godwinchf@gmail.com].

  6. For how long will this data be available start date provided 01-07-2025 and end date provided 31-12-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

the study will be conducted as follows:

Phase I: Quantitative strand

Step1: Approval from institutional ethics committee and obtain permission from the hospital authorities

Step 2: Selection of the sample based on the sampling criteria by using simple random sampling technique and random allocation into experimental and control group

Step 3: Obtains informed consent from the samples after adequate explanation

Step4: collect the sociodemographic and clinical data variable

Step 5: Training on comprehensive baby bond stimulation programme by using PowerPoint and video (Interventional group)

Step6: Assessment of bonding and mental health Imonth,2month after intervention and 4th week during postnatal period

·       Ethical clearance will be obtained from institutional ethics committee and get permission from the hospital authorities. Data will be collected from primigravida mothers attending antenatal OPD, Maternity ward of selected medical college hospital. The investigator selects the sample by using simple random sampling technique based on the sampling criteria. Random number generator will be used for selecting the samples.   Samples will be allocated to interventional and control group on alternative day basis. The investigator will obtain the informed consent from the sample after adequate explanation about the study.

·       Socio demographic and clinical data variables will be collected from    the interventional and the control group.

·       The experimental group will be given the training on baby bond stimulation programme on individual basis from third trimester of pregnancy(26-28wks) in two phases.  In phase I programme will be taught to the mother by using PowerPoint presentation and video for a duration of 30 minutes.  A leaflet will be given for further reference. In phase II reinforcement of the programme will be given through google meet on the next day. While the control group will be receiving the routine antenatal care. Mothers in the experimental group will be instructed to follow the programme as per the instructions and to maintain a diary to ensure the adherence.

·       Bonding and mental health is assessed from both the group when they come for the follow up in the OPD (one moth and two following the intervention and on 4th postnatal week)

  
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