| CTRI Number |
CTRI/2025/04/085753 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
prevalence of paternal postpartum depression |
|
Scientific Title of Study
|
A study to assess the prevalence and factors associated with paternal postpartum depression among fathers of infants visiting immunization clinic of a tertiary care hospital |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankit Kumar |
| Designation |
M.Sc. nursing student |
| Affiliation |
College of Nursing, AIIMS New Delhi |
| Address |
Ankit Kumar
M.Sc. nursing student
College of Nursing, AIIMS New Delhi (110029)
South
DELHI
0
India |
| Phone |
9928670697 |
| Fax |
|
| Email |
yadavankit200995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajesh Kumar T K |
| Designation |
associate professor |
| Affiliation |
College of Nursing, AIIMS New Delhi |
| Address |
Mr. Ajesh Kumar T K
Associate Professor
College Of Nursing, AIIMS New Delhi 110029
South
DELHI
0
India |
| Phone |
9729389569 |
| Fax |
|
| Email |
ajesh.ktk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajesh Kumar T K |
| Designation |
associate professor |
| Affiliation |
College of Nursing, AIIMS New Delhi |
| Address |
Mr. Ajesh Kumar T K
Associate Professor
College Of Nursing, AIIMS New Delhi 110029
South
DELHI
0
India |
| Phone |
9729389569 |
| Fax |
|
| Email |
ajesh.ktk@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Science, New Delhi, INDIA (110029) |
|
|
Primary Sponsor
|
| Name |
ANKIT KUMAR |
| Address |
ANKIT KUMAR, MSC NURSING STUDENT
COLLEGE OF NURSING, AIIMS NEW DELHI 110029 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| ANKIT KUMAR |
All India institute of medical science, New Delhi |
Room No. C-205, Immunization clinic, 2nd floor, NEW RAK OPD BLOCK, All India institute of medical science, New Delhi, INDIA (110029)
South
DELHI |
9928670697
yadavankit200995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF ALL INDIA INSTITUTE OF MEDICAL SCIENCES,NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
paternal postpartum depression |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
fathers having
Age between 21 to 45 years
Willing to participate in the study
Baby of age 12 month or younger
Who are able to read Hindi or English
|
|
| ExclusionCriteria |
| Details |
fathers having any known mental illness such as depression or mood disorders |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevalence of paternal postpartum depression |
Baseline data collection only as its a cross sectional study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify the protective factors & risk factors of paternal postpartum depression
To seek the association in prevalence of paternal postpartum depression with selected demographic variables.
|
baseline data collection only as its cross sectional study |
|
|
Target Sample Size
|
Total Sample Size="213"
Sample Size from India="213"
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)
|
06/05/2025 |
| 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="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
|
A descriptive cross sectional study to assess the prevalence of paternal postpartum depression among fathers. samples are selected based on inclusion and exclusion criteria selected for study and data will be collected with the help of Participant sociodemographic data sheet and Edinburgh postnatal depression scale until calculated sample size 213 is achieved. data will be analyzed with the help of appropriate descriptive and inferential statistics. |