| CTRI Number |
CTRI/2025/11/097842 [Registered on: 21/11/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on Development and Validation of Paternal Postnatal Scale (PPS) among First-Time Fathers |
|
Scientific Title of Study
|
Development And Validation of a Paternal Postnatal Scale (PPS) to Assess the Impact of Fatherhood on their Mental Health, Social Life and Personal Life among First Time Fathers in selected District, Uttarakhand |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Annu Panchal |
| Designation |
PhD Scholar |
| Affiliation |
Teerthanker Mahaveer College of Nursing , Teerthanker Mahaveer University |
| Address |
Teerthanker Mahaveer
College of Nursing
Teerthanker Mahaveer
University
NH-9 Delhi Road,
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7417327103 |
| Fax |
|
| Email |
annu.scholar@tmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Varun Toshniwal |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer College of Nursing , Teerthanker Mahaveer University |
| Address |
Teerthanker Mahaveer
College of Nursing
Teerthanker Mahaveer
University
NH-9, Delhi Road
Moradabad - 244001
Uttar Pradesh India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
8057000933 |
| Fax |
|
| Email |
varun.nursing@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Annu Panchal |
| Designation |
PhD Scholar |
| Affiliation |
Teerthanker Mahaveer College of Nursing , Teerthanker Mahaveer University |
| Address |
Teerthanker Mahaveer
College of Nursing
Teerthanker Mahaveer
University
NH-9 Delhi Road,
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7417327103 |
| Fax |
|
| Email |
annu.scholar@tmu.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Annu Panchal |
| Address |
Teerthanker Mahaveer
College of Nursing
, Teerthanker Mahaveer
University
NH-9, Delhi Road,
Moradabad - 244001,
Uttar Pradesh, India |
| 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 |
| Mr Lovelesh Sharma |
Community Area, Viakasnagar,Dehradun |
ommunity Area, Viakasnagar,Dehradun
Dehradun
UTTARANCHAL |
9897075357
loveshsharma72@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Teerthanker Mahaveer Dental College & Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Impact of Fatherhood on their Mental Health, Social Life and Personal Life |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1.First-time biological fathers:
Fathers who have become parents for the first time.
2.Postnatal period within 1 year:
Fathers whose child is between 1 month to 12 months old.
3.Age group:18 to 45 years:
Fathers within this age range to represent typical reproductive age.
4.Ability to read and understand the study language:
Participants who can comprehend the questionnaire in English/Hindi.
5.Willingness to participate:
Fathers who give informed consent to voluntarily participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Fathers with a history of diagnosed psychiatric illness
2.Fathers of children with serious congenital anomalies or chronic illnesses
3.Fathers who have experienced perinatal loss
4.Fathers undergoing any active psychological or psychiatric treatment
5.Unwilling or unable to complete the study tool/questionnaire:
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of the scale that will help to assess the Impact of Fatherhood on their Mental Health, Social Life and Personal Life among First Time Fathers |
Postnatal period within 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fathers are also identified as having depression, anxiety, or stress using standard tools |
During postnatal 1 year period |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
01/12/2025 |
| 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="4"
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 cross-sectional study will develop and psychometrically validate a Paternal Postnatal Scale (PPS) to measure the impact of early fatherhood on mental health, social life and personal life among first-time fathers in selected district, Uttarakhand. Phase 1 will generate items from literature review and qualitative interviews with fathers and experts, and pilot test the draft scale. Phase 2 will evaluate psychometric properties using exploratory factor analysis, confirmatory factor analysis, internal consistency (Cronbach’s alpha), test–retest reliability, and construct validity (convergent/divergent validity) against established measures. The study aims to produce a valid, reliable instrument for screening and research in paternal postnatal well-being. SYSTEMATIC DIAGRAMMATIC PRESENTATION OF SCALE DEVELOPMENT AND VALIDATION:- Step1:- Qualitative exploration: Focus interviews (n=10-15) , existing scale and literature review on impact on mental health, social life and personal life | Step2:- Qualitative exploration: Impact of fatherhood on their mental health, social life and personal life in first post birth year among first time fathers – Scale construct | Step3:- Qualitative validation: Expert Feedback Content validity |
Step 4:- Revising items based on the validation result | Step 5:- Quantitative Phase: Administering the new scale | |