CTRI Number |
CTRI/2022/07/044115 [Registered on: 19/07/2022] Trial Registered Prospectively |
Last Modified On: |
16/07/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Behavioral |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Impact of Skin to Skin contact by father |
Scientific Title of Study
|
A study to evaluate the effectiveness of skin to skin contact between father and baby delivered by lower segmental caesarean section in terms of paternal and neonatal outcomes in selected hospitals of Dadra and Nagar Haveli |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Priti Kanji Mohunkar |
Designation |
MSc. Nursing 2 nd year Student |
Affiliation |
Shri Vinoba Bhave College of Nursing silvassa D.N H |
Address |
Dudhani, Kauncha Jamalpada.Dadra and Nagar Haveli, Silvassa
Dadra & Nagar Haveli DADRA & NAGAR HAVELI 396230 India |
Phone |
7046412730 |
Fax |
|
Email |
pritimohunkar@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Vadivukkarasi P |
Designation |
Professor |
Affiliation |
Shri Vinoba Bhave College of Nursing, Silvassaa |
Address |
Shri Vinoba Bhave College of Nursing,Silvassa,
Dadra & Nagar Haveli DADRA & NAGAR HAVELI 396230 India |
Phone |
7046593297 |
Fax |
|
Email |
krishraghav2010@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Vadivukkarasi P |
Designation |
Professor |
Affiliation |
Shri Vinoba Bhave College of Nursing, Silvassaa |
Address |
Shri Vinoba Bhave College of Nursing,Silvassa,
DADRA & NAGAR HAVELI 396230 India |
Phone |
7046593297 |
Fax |
|
Email |
krishraghav2010@gmail.com |
|
Source of Monetary or Material Support
|
Material support will be availed from Shri Vinoba Bhave Civil Hospital, Silvassa |
|
Primary Sponsor
|
Name |
Shri Vinoba Bhave Civil Hospital Silvassa |
Address |
Shri Vinoba Bhave Civil Hospital,Silvassa, D.N.H 396230 India. |
Type of Sponsor |
Government medical college |
|
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 |
Dr Vadivukkarasi P |
Shri Vinoab Bhave Civil Hospital, Post operative wards, Silvassa, DNH |
Shri Vinoba Bhave Civil Hospital, Silvassa, DNH, 396230 Dadra & Nagar Haveli DADRA & NAGAR HAVELI |
7046593297
krishraghav2010@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee of NAMO Medical Education & Research Institute |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Fathers willing to participate in Skin to Skin contact |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Information Pamphlet on Skin to Skin contact by the father |
Fathers in comparison group will be receiving Information pamphlet on Skin to Skin contact bybthe father |
Intervention |
Skin to Skin contact by the father |
Skin to skin contact will be provided by the father for the duration of 30 minutes |
|
Inclusion Criteria
|
Age From |
19.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Male |
Details |
Fathers of the baby delivered by LSCS who do not smoke or drink alcohol, took bath and willing to participate in study and available during data collection period of 3 days |
|
ExclusionCriteria |
Details |
Fathers of the baby delivered by LSCS with congenital anomalies and hospitalized in NICU |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Pre-numbered or coded identical Containers |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Level of Father and Child attachment |
3 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Enhancement of Knowledge and Behaviour change in child care |
3 days |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
20/07/2022 |
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="0" Months="1" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
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)?
Response - NO
|
Brief Summary
|
INTRODUCTION
Perinatal care
typically focuses on the postpartum mother and her newborn infants. Reflecting
this phenomenon, most perinatal care research has focused on the mother during
the pregnancy and birthing, excluding the feelings and functions of the father.
The accumulate the experience necessary to realize their ideal parenting roles
using adjustments, trail, error and external assistance. Postpartum father-
neonate SSC engenders strong feelings in the father for his newborn, Increase
the environmental stimulation, provides critical emotional support, and
encourages the father to become actively involved in infant caring
responsibilities Touching, massaging and hugging an infant as well as learning
to respond appropriately to an infant’s crying each help new father Properly
interpret changes to infant appearance and behavior, provide appropriate
information, reduce parenthood discomfort and anxiety, better prepare for
parenting role responsibilities; and increase infant’s confidence. STATEMENT OF THE PROBLEM: A study to evaluate the effectiveness of skin-to-skin
contact between Father and baby delivered by Lower Segmental Caesarean Section
in terms of paternal and neonatal outcomes in selected hospitals of Dadra and
Nagar Haveli. OBJECTIVES: u Evaluate the effectiveness of skinÂ-to-skin contact
between Father and baby delivered by Lower Segmental Caesarean Section in terms
of paternal and neonatal outcome in selected hospitals of Dadra and Nagar
Haveli.
u Associate the paternal and neonatal outcomes with
selected Socio - demographic variables. HYPOTHESIS
u H1: There is no difference in paternal and
neonatal outcomes after the implementation of skin-to-skin contact between the
fathers in the experimental and control group at 0.05 level of significance. u H2: There is no association between the
paternal and neonatal outcome with selected Socio- Demographic variables at
0.05 level of significance.
|