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CTRI Number  CTRI/2025/04/084775 [Registered on: 15/04/2025] Trial Registered Prospectively
Last Modified On: 30/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prevalence of Anxiety Disorder in women of third trimester pregnancy  
Scientific Title of Study   Prevalence of Anxiety Disorder in women of third trimester pregnancy- A Cross-Sectional Descriptive Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dakshika Jain 
Designation  MD Post graduate 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Psychiatry, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9979798772  
Fax    
Email  jaindakshika@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bheemsain V Tekkalaki 
Designation  MD Associate Professor and Guide 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Psychiatry, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9886674849  
Fax    
Email  tbheemsain@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bheemsain V Tekkalaki 
Designation  MD Associate Professor and Guide 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Psychiatry, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9886674849  
Fax    
Email  tbheemsain@gmail.com  
 
Source of Monetary or Material Support  
KLE, KAHERs Dr. Prabhakar Kore Hospital and Medical Research, Centre,JNMC, Belagavi, 590010 Karnataka 
 
Primary Sponsor  
Name  Dr. Dakshika Jain  
Address  Department of Psychiatry, KAHERs Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi, 590010 
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 Dakshika Jain  KAHERs Dr. Prabhakar Kore Hospital and Medical Research Centre  Third trimester pregnant women visiting the Department of Obstetrics and Gynaecology at KLE’s Dr. Prabhakar Kore Hospital
Belgaum
KARNATAKA 		 9979798772

jaindakshika@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Third Trimester Pregnant Women 
Patients  (1) ICD-10 Condition: O993||Mental disorders and diseases of the nervous system complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  49.00 Year(s)
Gender  Female 
Details  A) All women in third trimester pregnancy.
B) Participants who are willing to give informed consent.

 
 
ExclusionCriteria 
Details  A)Patients with independent mood disorders or psychotic disorders.
B)Patients with substance use disorder except nicotine use disorder.
C)Patients with serious pregnancy related complications.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the prevalence of anxiety disorders in women of third trimester pregnancy by using ICD 11 diagnosis criteria and use Hamilton Anxiety Rating Scale(HAM- A) to rate the severity of anxiety disorder in the participants.

 		 Third Trimester Pregnant female

 
 
Secondary Outcome  
Outcome  TimePoints 
To assess demographic and clinical factors affecting the anxiety disorder in women of third trimester pregnancy  Third Trimester Pregnant female 
 
Target Sample Size   Total Sample Size="165"
Sample Size from India="165" 
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)   21/04/2025 
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   This study aims to determine the prevalence of anxiety disorder in third trimester pregnant female in India and also to understand the factors affecting the same. Even though similar studies have been carried out in other parts of the
world, it is crucial to understand the prevalence of anxiety in women in third trimester for the Indian population because there are cultural differences in terms of attitude towards mental illness, help seeking behaviour and the attached stigma. This cross-sectional descriptive study will be  conducted at KAHER’s Dr. Prabhakar Kore Charitable Hospital and MRC, Belagavi and will involve third trimester pregnant female. The study’s methodology includes  taking informed consent, all eligible participants will be subjected to semi- structured questionnaires to document socio-demographic and clinical details.ICD 11 DCR criteria will be used to diagnose anxiety disorder. Hamilton Anxiety Rating Scale(HAM- A) will be applied to rate  the severity of anxiety disorder in the participants.The data obtained will be tabulated using Microsoft Excel. The sociodemographic and clinical details of the patients will be described using percentages (for categorical variables) or as mean and standard deviation (for continuous variable). The prevalence will be calculated using the formula P= number of participants having anxiety disorder / total number of participants

The subjects will be divided into 2 categories based on the presence or absence of anxiety disorder. Sociodemographic and clinical details of both the groups will be taken and compared. Both the groups will be compared using appropriate test of significance (categorical data using chi square test and continuous data using student t test). All tests will be two tailed. A p value of less than 0.05 is considered significant.

 

 
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