| CTRI Number |
CTRI/2025/01/078951 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
02/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Mental health of mothers of NICU admitted infants |
|
Scientific Title of Study
|
Study of mental health and its determinants in mothers of NICU admitted infants |
| 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. Shakun Tyagi |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Lok Nayak Hospital associated with Maulana Azad Medical College, Obstetrics & Gynaecology Department Room No.- OG-33, third floor, New Delhi - 110002
New Delhi
DELHI
110002
India |
| Phone |
8860188763 |
| Fax |
|
| Email |
tyagishakun@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shakun Tyagi |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Lok Nayak Hospital associated with Maulana Azad Medical College, Obstetrics & Gynaecology Department Room No.- OG-33, third floor, New Delhi - 110002
New Delhi
DELHI
110002
India |
| Phone |
8860188763 |
| Fax |
|
| Email |
tyagishakun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Shakun Tyagi |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Lok Nayak Hospital associated with Maulana Azad Medical College, Obstetrics & Gynaecology Department Room No.- OG-33, third floor, New Delhi - 110002
New Delhi
DELHI
110002
India |
| Phone |
8860188763 |
| Fax |
|
| Email |
tyagishakun@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Lok Nayak Hospital |
| Address |
Lok Nayak Hospital associated with Maulana Azad Medical College, Obstetrics & Gynaecology Department Room No.- OG-33, third floor, New Delhi - 110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shakun Tyagi |
Lok Nayak Hospital |
Obstetrics & Gynaecology Department Room No.- OG-33, third floor, New Delhi - 110002
New Delhi
DELHI |
8860188763
tyagishakun@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee,MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F09||Mental disorders due to known physiological conditions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Mothers of infants admitted in NICU for more than 48 hours |
|
| ExclusionCriteria |
| Details |
1. Women who are known cases ( medication or counseling) of any of the following mental health issues - depression, Anxiety, Stress, Bipolar Disorder, Generalized Anxiety Disorder (mild, moderate, severe)
2. Patients with mental health or neurological complications. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of this study is to evaluate the prevalence of mental health issues among mothers of infants admitted to the NICU using standardized scales. |
after 48 hours of delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A comprehensive understanding of the factors that influence the mental health of mothers of infant admitted to NICU, including Demographic Factors, Family & Social Factors, Pregnancy & NICU Factors & Psychological & Medical History (if any). A deeper understanding of the relationships between Neonatal admission to NICU & its impact on mothers mental health. The findings will provide evidence- based recommendations for psychological support to such mothers, leading to improved mental health. |
After 48 hours of delivery |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
28/01/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
The purpose of this study to understand the mental health, of mothers of NICU-admitted infants. In addition to that, this study will also help in understanding how other factors can contribute in increasing the risk of mental illness. There are many factors that may contribute in deteriorating the mental health of a mother. In this study those factors would also be included. The additional factors that may increase the risk of maternal mental illness are:-
1 Demographic Factors: (Husband’s qualification, Patient’s qualification. Age of marriage. Age during first pregnancy. No. of children, Patient’s working status. No. of Abortion and gender of baby)
2. Family and Social Factors: (Family type. Type of marriage, Intimate partner support, Domestic violence, Marriage conflict (if any). In-laws family support during pregnancy)
3. Pregnancy and NICU Factors (Was the pregnancy planned or unwanted. Duration of admitted to NICU at the time of interview)
4. Psychological and Medical History [clinical history of mental illness (if any), Family history of mental illness)
The findings will help the healthcare providers about the critical issues faced by mothers of infants admitted to NICU, during the postpartum period, consequently they can implement appropriate therapies to support the mental health and well- being of mothers in need. |