| CTRI Number |
CTRI/2018/09/015738 [Registered on: 17/09/2018] Trial Registered Prospectively |
| Last Modified On: |
14/09/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study comparing the routine care with video assisted teaching of breast feeding skills near delivery on exclusive breast feeding in women becoming pregnant for the first time. |
|
Scientific Title of Study
|
effect of video assisted teaching on breast feeding skills and exclusive breast feeding at 6 weeks compared to standard care among primigravida women delivering at term-a randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
EJPPavithra |
| Designation |
1 year MSC Nursing student |
| Affiliation |
JIPMER |
| Address |
College of Nursing JIPMER Pondicherry-605006
India
-
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8220000721 |
| Fax |
|
| Email |
ejppavithra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs vahitha |
| Designation |
lecturer |
| Affiliation |
JIPMER |
| Address |
college of nursing
JIPMER
nil
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9840924805 |
| Fax |
|
| Email |
vahiarun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anish keepanasseril |
| Designation |
associate professor |
| Affiliation |
JIPMER |
| Address |
Department of Obstetrics and Gynaecology
JIPMER
nil
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8903307141 |
| Fax |
|
| Email |
keepan_r@yahoo.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
JIPMER |
| Address |
Dhanvantri Nagar, Gorimedu, Pondicherry 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| EJP pavithra |
JIPMER Women and children hospital |
Antenatal OPD,
(Ground floor)
Dept of Obstetrics & Gyencology, JIPMER
Dhanvantri Nagar
Pondicherry
PONDICHERRY |
8220000721
ejppavithra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics 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 |
| Comparator Agent |
standard care among primigravida antenatal mother admitted in JIPMER |
primigravida women with 37 weeks of gestation will be provided with standard care in JIPMER |
| Intervention |
video assisted teaching on breastfeeding skills and exclusive breast feeding compared with standard care
|
Intervention group:video assisted teaching on breastfeeding skills and exclusive breast feeding
control group: standard care provided by the hospital. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
32.00 Year(s) |
| Gender |
Female |
| Details |
antenatal primigravida women :18-32 years willing to participate in the study attending antenatal OPD in WCH JIPMER
subjects who are healthy are fit for intervention |
|
| ExclusionCriteria |
| Details |
primigravida mothers who are not willing to participate in the study and with obstetrical complications will be provided with standard care by the hospital services. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| effect of video assisted teaching on breast feeding skills and exclusive breast feeding |
six weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
17/09/2018 |
| 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
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized control trial ,comparing the effectiveness of video assisted teaching on breast feeding and exclusive breast feeding to the standard care provided by the hospital services in the selected tertiary care hospital JIPMER at pondicherry ,India .the intervention and the control group will be administered with pretest using the knowledge questionnarie and the intervention group will be provided with video assisted teaching on breast feeding skills and exclusive breast feeding and the control group will be provided with the standard care during the antenatal period followed by the delivery both the groups will be administered with post test by the same questionnarie and the breast feeding skills will be assessed by using observation checklist and the primary outcome of the study will be measures will be by theeffect of video assisted teaching on improving knowledge and skill in breast feeding. |