| CTRI Number |
CTRI/2019/08/020777 [Registered on: 19/08/2019] Trial Registered Prospectively |
| Last Modified On: |
24/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative |
| Study Design |
Other |
|
Public Title of Study
|
Mothers experience of caring for a preterm infant |
|
Scientific Title of Study
|
Understanding mothers experience of caring for a preterm infant: An exploratory study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rupambika sahoo |
| Designation |
Assistant Professor |
| Affiliation |
Manipal college of Health Professions |
| Address |
Department of Occupational Therapy
MCHP
MAHE
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7022884438 |
| Fax |
|
| Email |
rupambikasahoo.svnirtar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rupambika sahoo |
| Designation |
Assistant Professor |
| Affiliation |
Manipal college of Health Professions |
| Address |
Department of Occupational Therapy
MCHP
MAHE
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7022884438 |
| Fax |
|
| Email |
rupambikasahoo.svnirtar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rupambika sahoo |
| Designation |
Assistant Professor |
| Affiliation |
Manipal college of Health Professions |
| Address |
Department of Occupational Therapy
MCHP
MAHE
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7022884438 |
| Fax |
|
| Email |
rupambikasahoo.svnirtar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neonatal Intensive Care Unit(NICU)
Kasturba Hospital
KMC
Manipal
Karnataka |
|
|
Primary Sponsor
|
| Name |
Rupambika Sahoo |
| Address |
Department of Occupational Therapy
3rd floor MCHP
MAHE
Manipal |
| Type of Sponsor |
Other [Myself] |
|
|
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 |
| Rupambika Sahoo |
Kasturba Medical College |
Department of pediatrics
Neonatal Intensive Care Unit
1st floor, follow up room
Women and Child block
MAHE
Manipal
Udupi
KARNATAKA |
7022884438
rupambikasahoo.svnirtar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mother having pre term infant |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
The inclusion criteria of this study will be: primigravida mother of a preterm infant admitted in NICU and not more than six months old at the time of the interview, who understands Hindi/English/Kannada, has functional reading, comprehension, and communication and is willing to participate in this study |
|
| ExclusionCriteria |
| Details |
Exclusion criteria will be mother having postpartum psychosis, known psychiatric disorder, cognitive impairments, any co-existing neurological disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
In depth interview on mothers experience of caring for the preterm infant
Thematic analysis will be done to analyse the same. |
In depth interview on mothers experience of caring for the preterm infant
Thematic analysis will be done to analyse the same. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "6"
Final Enrollment numbers achieved (India)="6" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/08/2019 |
| Date of Study Completion (India) |
06/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Social Participation in Children with Cerebral Palsy
 Online Journal of Health and Allied Sciences |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A mother is the primary caregiver for a preterm infant and therefore the primary medium to deliver early intervention therapy. Therefore, the mother is the primary focus for the health care professional to deliver the family-centred practice. Understanding the mother’s experience is an asset to provide the individual and context-specific therapy to the infant. However, most of the literature reviewed were on the western population. As socio-economic, cultural and contextual factors influence caring for the infant, the findings of studies from other cultures may not be generalizable to the Indian context. There is a paucity of literature in the Indian context with the only available study that reported moderate compliance with early intervention at home. To bridge that gap, it imperative to understand the mother’s experience The study aims to understand the mothers’ experiences of caring for her preterm infant in NICU and at Home. |