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CTRI Number  CTRI/2024/09/074260 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 24/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Survey regarding awareness of Maternal Mental Health among Healthcare Providers 
Scientific Title of Study   Blueprint for better Maternal Mental Health Policy: A comprehensive exploration of policy structure, healthcare providers’ insights, and stakeholders’ engagement  
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 Shreya Sharma 
Designation  PhD Research scholar 
Affiliation  Department of basic medical sciences (DBMS), MAHE, Manipal  
Address  Department of basic medical sciences, 2nd floor, MMMC building, MAHE, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7007576079  
Fax    
Email  shreya.dbmsmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Sambit Dash 
Designation  Assistant Professor (Selection Grade) 
Affiliation  Department of basic medical sciences DBMS ,MAHE, Manipal  
Address  Department of basic medical sciences, 2nd floor, MMMC building, MAHE, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9986104763  
Fax    
Email  sambit.dash@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Samir Kumar Praharaj 
Designation  Professor and Head 
Affiliation  Kasturba Medical College and Hospital, Manipal 
Address  Department of Psychiatry,Room no. 33, Kasturba Medical College and Hospital, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  8971026304  
Fax    
Email  samir.kp@manipal.edu  
 
Source of Monetary or Material Support  
Department of Basic Medical Sciences, Manipal Academy of Higher Education 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shreya Sharma  Kasturba Medical College and Hospital, Manipal  Department of Psychiatry- Room no. 33, Department of Obstretrics and Gynecology- Women and Child Development Block, Department of Pediatrics- Ground floor, KMC Manipal.
Udupi
KARNATAKA 		 7007576079

shreya.dbmsmpl2023@learner.manipal.edu 
Dr Shreya Sharma  Online- Telephonic  NA

 		 7007576079

shreya.dbmsmpl2023@learner.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  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Normal 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Part 1: The participants will be selected from the department of obstetrics-gynecology, pediatrics, and
psychiatry including doctors, postgraduate students, interns and nurses.
Part 2: Tertiary healthcare facilities including government and private facilities.
• Facilities with obstetrics-gynecology, pediatrics, and psychiatry departments, with at least two
departments from above mentioned or facilities with at least one department among the departments mentioned. 
 
ExclusionCriteria 
Details  Participants not meeting the inclusion criteria will be excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Policy Integration and Amendments  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   07/10/2024 
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="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  

Title: Blueprint for Better Maternal Mental Health Policy: A Comprehensive Exploration of Policy Structure, Healthcare Providers’ Insights, and Stakeholders’ Engagement

Type of Study: Prospective cross-sectional study.

Aims & Objectives:

  1. Evaluate healthcare providers’ knowledge, attitudes, and perceptions of Maternal Mental Health (MMH).
  2. Analyze state health policies on MMH, focusing on Kerala and Telangana.
  3. Evaluate the National Mental Health Program (NMHP) and Reproductive Maternal Neonatal Child Health Adolescents (RMNCHA) Program with an intersectional approach.
  4. Explore stakeholders’ perceptions, influence, impact, networks, and roles in MMH policymaking.

Justification: 

There is a lack of adequate training, standardized tools, and treatment protocols for MMH in India.

Existing policies often neglect MMH, highlighting the need for inclusion and exploration of barriers.

Evaluation of existing mental health programs and research on cost-effective resource allocation is essential.

Departments Involved: Psychiatry, Obstetrics/Gynecology, Pediatrics (Recruitment Site), Division of Biochemistry (Co-coordinating department), DBMS, MAHE, and Psychiatry department, KMC, Manipal.

Study Period: 3 years.

Sample Size:

Objective 1: Part 1 - n=20, Part 2 - n=20.

Materials and Methods:

Inclusion Criteria: Healthcare providers from obstetrics-gynecology, pediatrics, and psychiatry departments; tertiary healthcare facilities with the relevant departments.

Statistical Methods: SPSS software; frequency analysis, chi-square test, and correlation analysis.

Tools Used: Self-reported semi-structured questionnaire.

Phases of the Study:

Phase 1

Objective: Assess knowledge, attitude, and perception of healthcare providers towards MMH.

Method: Development and validation of a self-reported questionnaire, telephonic survey of healthcare facilities.

Phase 2

Objective: Analyze state health policies on MMH in Kerala and Telangana.

Method: Case study analysis, policy evaluation using various health surveys and proxy indicators.

Phase 3

Method: SWOC analysis, Health-related Policy Analysis Tool (HrPAT), gender-responsive evaluation, Shiffman and Smith Framework analysis, and intersectionality-based policy analysis (IBPA).

Objective: Evaluate NMHP and RMNCHA programs.

Phase 4

Objective: Explore the roles and networks of stakeholders in MMH policymaking.

Method: Stakeholder mapping, MCDA tool, focus group discussions, social network analysis (SNA), development of a stakeholder engagement framework.

Outcome Measures

Integration of MMH into national and state policies.

Evaluation of program effectiveness in MMH.

Recommendations for policy and program enhancements.

Potential Risks and Benefits

Benefits: Contribution to SDG 3 by improving maternal health outcomes and mental well-being through enhanced policies, training, and program effectiveness.

Ethical Considerations: Ensuring informed consent, privacy, conflict disclosure, and regulatory compliance.

Budget and Funding:

Self-funded with an estimated budget of INR 1,40,000.

Grant application submitted to the Indian Council of Social Science Research (ICSSR).

Review of Literature:

Highlights the gaps in MMH knowledge, training, and policy integration.

Emphasizes the need for tailored training, standardized protocols, and comprehensive policy and program evaluation.

 
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