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CTRI Number  CTRI/2026/03/107200 [Registered on: 30/03/2026] Trial Registered Prospectively
Last Modified On: 30/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Motivational Counseling (MC) on Fear of Childbirth (FOC), anxiety, depression, and perinatal outcome among Primigravid women 
Scientific Title of Study   Effectiveness of Motivational Counseling (MC) on Fear of Childbirth (FOC), anxiety, depression, and perinatal outcome among Primigravid women in selected Maternity Hospitals 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mary Rexline S 
Designation  Professor/PhD Scholar 
Affiliation  Vydehi Institute of Nursing Sciences and Research Centre 
Address  Department of OBG Nursing VINS &RC #82 EPIP Area Nallurhalli, Whitefield Bangalore - 560066

Bangalore
KARNATAKA
560066
India 
Phone  8496920711  
Fax    
Email  annandrew141@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mary Rexline S 
Designation  Professor 
Affiliation  Vydehi Institute of Nursing Sciences and Research Centre 
Address  Department of OBG Nursing VINS &RC #82 EPIP Area Nallurhalli, Whitefield Bangalore - 560066

Bangalore
KARNATAKA
560066
India 
Phone  8496920711  
Fax    
Email  annandrew141@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr S ANUCHITHRA RADHAKRISHNAN 
Designation  VICE PRINCIPAL 
Affiliation  SDS TRC and RGICD College of Nursing 
Address  SDS TRC and RGICD College of Nursing Near NIMHANS Bangalore-560029

Bangalore
KARNATAKA
560029
India 
Phone  9342297964  
Fax    
Email  dr.anu76@yahoo.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  MARY REXLINE S 
Address  #82 EPIP Area Nallurhalli Whitefield Bengaluru 560066 
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 
Dr Mohua Maifi  BBMP, Austin Town Maternity Centre  Austin Town, Opposite to Raja Rajeshwari Temple, Viveknagar post, Bengaluru- 560047
Bangalore
KARNATAKA 		 8310595985

asstsurgatmh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical review board, VIMS &RC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Primigravid women 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Motivational Counseling  Primigravid women will undergo motivational counseling for three sessions at 28 to 30 weeks of gestation,30 to 32 weeks of gestation and 32 to 34 weeks of gestation respectively by the trained Researcher 
Comparator Agent  Routine care during their antenatal visits  Routine care at the time of their visits between 28 to 30, , 30 to 32 weeks and between 32 to 34 of gestation at maternity hospital 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  Primigravid women who
has planned their regular checkups and delivery in selected Hospital, Bangalore
are able to understand, read and communicate in Kannada or in English.
are between 28th to 30th weeks of gestation onwards.
are aged between 21-30years
are carrying singleton baby.
 
 
ExclusionCriteria 
Details  Primigravid women who
are at high-risk with pre-existing medical conditions, and pregnancy complications
with Psychiatric morbidity
currently receiving psychological treatment or counseling.
has a history of substance abuse
are unable to provide informed consent due to cognitive impairments or other reasons.
have no fear of childbirth,Minimal anxiety,and No depression during pretest assessment.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in fear of childbirth, anxiety, and depression during pregnancy to have an optimum perinatal outcome .  pretest between 28 to 30 weeks of gestation Post test between 32 to 34 weeks of Gestation among Primigravid women and soon after delivery the perinatal outcome will be assessed. 
 
Secondary Outcome  
Outcome  TimePoints 
OPTIMUM PERINATAL OUTCOME  AFTER DELIVERY 
 
Target Sample Size   Total Sample Size="158"
Sample Size from India="158" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   10/04/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

The purpose of the study is to assess and compare primigravid women who receive Motivational Counseling (MC) with those who receive standard prenatal care in terms of Fear of Childbirth (FOC), anxiety, depression, and perinatal outcomes. The study further proposes to  identify and analyze any demographic factors that may moderate in reducing Fear of Childbirth (FOC) anxiety and depression among primigravid women.

 
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