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CTRI Number  CTRI/2025/10/095876 [Registered on: 10/10/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Correlational 
Study Design  Other 
Public Title of Study   Transition to parenthood, anxiety, coping and bonding among parents of newborns 
Scientific Title of Study   A correlative study on transition to parenthood, anxiety, coping and bonding during the postpartum period among parents of newborns in selected tertiary referral hospital, Udupi district Karnataka 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Simran Chettri 
Designation  P G Student 
Affiliation  Manipal College of Nursing Manipal Academy of higher education 
Address  4th floor, Room no 400 A ,Department of OBG Nursing Manipal College Of Nursing Manipal Udupi District
6th floor, Room no 613 OBG Nursing Skill Lab 2,Department of OBG Nursing Manipal College Of Nursing Manipal Udupi District
Udupi
KARNATAKA
576104
India 
Phone  6296837126  
Fax  08202922572  
Email  simranchettri2025@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonia R B D Souza 
Designation  Professor and HOD 
Affiliation  Manipal College of Nursing Manipal Academy of higher education 
Address  Room No 603 B HOD OBG Nursing, Department of obstetric and gynaecological Nursing, Manipal College Of Nursing, Manipal academy of Higher Education, Manipal, Udupi District, Karnataka.

Udupi
KARNATAKA
576104
India 
Phone  9844732883  
Fax  8202922572  
Email  sonia.r@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sonia R B D Souza 
Designation  Professor and HOD 
Affiliation  Manipal College of Nursing Manipal Academy of higher education 
Address  Room No 603 B HOD OBG Nursing, Department of obstetric and gynaecological Nursing, Manipal College Of Nursing, Manipal academy of Higher Education, Manipal, Udupi District, Karnataka.

Udupi
KARNATAKA
576104
India 
Phone  9844732883  
Fax  8202922572  
Email  sonia.r@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital, Madhav Nagar, Manipal,Karnataka, India - 576104 
 
Primary Sponsor  
Name  Simran Chettri 
Address  Manipal College of Nursing, Manipal Academy of Higher Education (MAHE), Madhav Nagar Manipal, Udupi District, Karnataka 576104 
Type of Sponsor  Other [Self] 
 
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 
Jyothi Shetty  Kasturba Hospital  3RD FLOOR ,Ward no 2 and Ward no 5,Department of Women and Child Health, Kasturba Hospital, Manipal 576104
Udupi
KARNATAKA 		 9845973697

jyothi.shetty@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2(Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Postpartum parents 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1 First time parents prior to discharge from the hospital
2 Women who are in postpartum period (post-caesarean mothers) and their partners
3 Participants who can read, write and communicate in English and Kannada
 
 
ExclusionCriteria 
Details  1 The parents who are diagnosed as mentally challenged and with psychiatric conditions
2 Women who have postpartum complications
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
transition to parenthood, anxiety, coping and bonding of first-time parents (mothers who have undergone caesarean delivery and their partners/fathers) of newborns and relationship among these variables   Only one time measurement on the 4th day after childbirth after caesarean delivery predischarge  
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
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)   01/12/2025 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Well, there is extensive literature on the transition to parenthood and maternal-infant bonding in the late postpartum period, but there are limited studies about the early postpartum period and partners are minimally included. On top of it, most studies during the transition to parenthood focus on Western contexts, leaving a gap in understanding how cultural and societal norms in India affect transition to parenthood. This study will explore the transition to parenthood, anxiety, coping, and its influence on postpartum bonding particularly in Indian context not only for women but also for the men which is equally important for the period of transition. (Philpott, 2022), suggest that study has to be done to assess the mental health of fathers, including stress, anxiety and the coexistence of the symptoms to ensure the broader understanding. Understanding the transition period of the parents of newborns will ensure to tailor the need of better parenting and quality of the care for the newborn parents .

 
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