| CTRI Number |
CTRI/2018/04/013250 [Registered on: 13/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
06/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to assess the Effectiveness of Animated video assisted teaching on knowledge and practice of manual expression of breast milk among primiparous mothers of preterm babies in selected hospitals at Kozhikode. |
|
Scientific Title of Study
|
Effectiveness of Animated Video Assisted Teaching on Manual Expression of Breast Milk |
| Trial Acronym |
Eavatmeb |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priya M |
| Designation |
Lecturer |
| Affiliation |
MIMS College of Nursing |
| Address |
Child Health Nursing Department
MIMS College of Nursing
Vadakedathparamba
Puthukode(PO)
Vazhayur
Near Ramanattukara
Malappuram District
Kerala
India
Child Health Nursing Department
MIMS College of Nursing
Vadakedathparamba
Puthukode(PO)
Vazhayur
Near Ramanattukara
Malappuram District
Kerala
India
Malappuram
KERALA
673633
India |
| Phone |
811378472 |
| Fax |
04832832992 |
| Email |
priyamnayarkuzhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Assuma Beevi T M |
| Designation |
Principal |
| Affiliation |
MIMS College of Nursing |
| Address |
MIMS College of Nursing
Vadakedathparamba
Puthukode(PO)
Vazhayur
Near Ramanattukara
Malappuram District
Kerala
India
MIMS College of Nursing
Vadakedathparamba
Puthukode(PO)
Vazhayur
Near Ramanattukara
Malappuram District
Kerala
India
Malappuram
KERALA
673633
India |
| Phone |
9895780859 |
| Fax |
04832832992 |
| Email |
principal@mimscon.com |
|
Details of Contact Person
Public Query
|
| Name |
Priya M |
| Designation |
Lecturer |
| Affiliation |
MIMS College of Nursing |
| Address |
Child Health Nursing Department
MIMS College of Nursing
Vadakedathparamba
Puthukode(PO)
Vazhayur
Near Ramanattukara
Malappuram District
Kerala
India
Child Health Nursing Department
MIMS College of Nursing
Vadakedathparamba
Puthukode(PO)
Vazhayur
Near Ramanattukara
Malappuram District
Kerala
India
Malappuram
KERALA
673633
India |
| Phone |
811378472 |
| Fax |
04832832992 |
| Email |
priyamnayarkuzhi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MIMS College of Nursing |
| Address |
MIMS College of Nursing
Vadakedathparamba
Puthukode(PO)
Vazhayur
Near Ramanattukara
Malappuram District
Kerala
India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Priya M |
Aster MIMS |
Neonatal Intensive Care Unit
Aster MIMS
Govindapuram
Kozhikode
Kozhikode
KERALA |
8113878472
04832832992
priyamnayarkuzhi@gmail.com |
| Priya M |
Santhi Hospital |
Neonatal Intensive Care Unit
Santhi Hospital
Omasharey
Calicut
Kozhikode
KERALA |
8113878472
04832832992
priyamnayarkuzhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Malabar Institute of Medical Sciences Ltd (MIMS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Problem in Breast Milk Expression |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Animated Video Assisted Teaching
Comparator Agent Not Applicable
|
Intervention given 1 time for the sample. Seven days after the intervention posttest assessed. Comparator agent not applicable |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Primiparous mother of preterm babies |
|
| ExclusionCriteria |
| Details |
Mother with breast complications |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge and practice of primiparous mothers on breast milk expression will improve |
7 days after the intervention knowledge and practice will improve |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
09/12/2016 |
| Date of Study Completion (India) |
31/12/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The trial is to assess the
effectiveness of animated video assisted teaching on manual expression of
breast milk on knowledge and practice of primiparous mothers of preterm babies.
After the animated video assisted teaching the knowledge and
practice of primiparous mothers improved.. |