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CTRI Number  CTRI/2025/03/081923 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 05/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Co-relational study 
Study Design  Other 
Public Title of Study   To assess the level of Anxiety Depression Stress and Associated Factors among Pregnant Women  
Scientific Title of Study   Prevalence of Perinatal Anxiety Depression Stress and Associated Factors among women in a Hospital in Mangaluru.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lalbiakhliri 
Designation  1st MSc Nursing Student  
Affiliation  Father Muller College of Nursing  
Address  Father Muller College of Nursing Kankanady Mangalore Dakshina Kannada

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845494067  
Fax    
Email  srveronicalb@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Reena Frank  
Designation  Associate Professor 
Affiliation  Father Muller College of Nursing  
Address  Department of Obstrestic and Gynecology Father Muller College of Nursing Kankanady Mangalore Dakshina Kannada

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9964078984  
Fax    
Email  rinwil21@fathermuller.in  
 
Details of Contact Person
Public Query  
Name  Lalbiakhliri 
Designation  1st MSc Nursing Student  
Affiliation  Father Muller College of Nursing  
Address  Father Muller College of Nursing Kankanady Mangalore Dakshina Kannada

Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845494067  
Fax    
Email  srveronicalb@gmail.com  
 
Source of Monetary or Material Support  
Father muller college of Nursing Kankanady Mangaluru 575002 
 
Primary Sponsor  
Name  Lalbiakhliri 
Address  Father muller college of Nursing Kankanady Mangaluru 575002 
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 
Lalbiakhliri  outpatFather Muller Medical College Hospital  Father Muller Medical College Hospital, Department of obstetrics and gynecology 1st floor Kankanady Mangaluru Dakshina Kannada karnataka 575002
Dakshina Kannada
KARNATAKA 		 9845494067

srveronicalb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant women who are in their Second and third Trimester  
Patients  (1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Women in their second and third trimester
Those who are speaking in English and Kannada 
 
ExclusionCriteria 
Details  Previous history of psychological disorders and on antidepressant.

High-risk antenatal women whose ultrasound shows foetal anomalies
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To know the prevalence of Anxiety, Depression, Stress and Associated Factors among pregnant women   2 years  
 
Secondary Outcome  
Outcome  TimePoints 
To know the prevalence of Anxiety Depression Stress & Associated Factors among pregnant women   5 years 
 
Target Sample Size   Total Sample Size="341"
Sample Size from India="341" 
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)   10/03/2025 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 26-01-2026 and end date provided 26-01-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   The antenatal period covers the time from conception until birth and during this period the woman is going through various changes physically and mentally due to the hormonal changes. The rise of certain mental issues such as anxiety, depression and stress during pregnancy and soon after childbirth is common in most of the women. The untreated case can lead to its severity and cause complications in the child and in the mother. The previous studies conducted in different area shows the increase of the prevalence of perinatal Anxiety, Depression and Stress. As it is said “The healthy future of society depends on the health of today’s children and their mothers, who are guardians of that future” it is necessary to know the physical and mental health status of expected women in order to make known to them the essential prevention and treatment. In order to know and understand such an existence and prevalence research is an essential step. 
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