| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [godwinchf@gmail.com].
- 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.
- 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) |