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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 skin­-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. 


 
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