| CTRI Number |
CTRI/2025/12/098699 [Registered on: 09/12/2025] Trial Registered Prospectively |
| Last Modified On: |
06/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Simulation linked educational intervention ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
How Simulation Linked Education To Empower Mothers in Managing Fever Related Seizure at Home |
|
Scientific Title of Study
|
Effectiveness Of Simulation Linked Educational Intervention On Competencies In Home Base Management Of Febrile Seizure Among Mothers Of Under Five Children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mrs Amitha R |
| Designation |
Associate Professor |
| Affiliation |
BGS College Of Nursing |
| Address |
BGS International Foundation For Health Sciences BGS College Of Nursing
1st floor Child health department room no 2
Aadhichunchanagiri Road Apollo Hospital Premises Kuvempunagar
Mysore Karnataka
same
Mysore
KARNATAKA
570023
India |
| Phone |
9844428387 |
| Fax |
|
| Email |
amitha.scholar@tmu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Kumar |
| Designation |
Professor |
| Affiliation |
Teerthanker Mahaveer University |
| Address |
Department of Child Health Nursing Teerthanker Mahaveer University College Of Nursing Delhi Road NH 24 Bagadpur Moradabad Uttar Pradesh India
Department of Child Health Nursing Teerthanker Mahaveer University College Of Nursing Delhi Road NH 24 Bagadpur Moradabad Uttar Pradesh India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9813893463 |
| Fax |
|
| Email |
dryogesh.nursing@tmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Amitha R |
| Designation |
Associate Professor |
| Affiliation |
BGS College Of Nursing |
| Address |
BGS International Foundation For Health Sciences BGS College Of Nursing
1st floor Child health department room no 2
Aadhichunchanagiri Road Apollo Hospital Premises Kuvempunagar
Mysore Karnataka
same
Mysore
KARNATAKA
570023
India |
| Phone |
9844428387 |
| Fax |
|
| Email |
amitha.scholar@tmu.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer University |
| Address |
Teerthanker Mahaveer University College Of Nursing NH24 Delhi Road Bagadpur Moradabad Uttar Pradesh 244001 |
| Type of Sponsor |
Other [Private Nursing College ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| no sponsor |
nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mrs Varsha |
PHCs Under Heggadadevana kote Taluk |
Taluk Health Officer
Taluk Health office (General hospital)
Heggadadevana kote
Mysore- 571441
Mysore
KARNATAKA |
09900510737
varshamahaveer2002@gmail.com |
| Mr Yadugiri |
PHCs Under Yalandooru Taluk |
Taluk Health Officer
Taluk Health Hospital Yalandooru
Chamarajanagara (D)- 571441
Chamarajanagar
KARNATAKA |
9036857321
amithabgs22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, TEERTHANKER MAHAVEER DENTAL COLLEGE & RESEARCH CENTER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy mothers of underfive children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
mothers of under five mothers will receive Simulation linked educational intervention |
After the pre-test, mothers of under-five children will receive a simulation-linked educational intervention module on competencies in home-based management of febrile seizures, and after 4 weeks, the post-test will be conducted. |
| Comparator Agent |
simulation based educational intervention module |
Module includes structure teaching, demonstration,3 sets different age group simulation scenarios. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 Mothers of children aged below five years.
2 Residing in the selected community or area of study.
3 Available and willing to participate in the full duration of the
educational intervention and data collection.
4 Able to understand and communicate in the local language.
5 Not previously trained or educated formally regarding febrile
seizure management. |
|
| ExclusionCriteria |
| Details |
1 Mothers whose children have a diagnosed neurological disorder
other than febrile seizures.
2 Healthcare professionals or mothers with formal health-related
education
3 Mothers with hearing, cognitive, or visual impairments that
hinder learning through simulation.
4 Unwilling or unable to give informed consent.
5 Mothers who are temporarily visiting the area and not permanent
residents |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Enhance competencies in home based management of febrile seizures among mothers of under five years children |
4 weeks After providing simulation based educational intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| enhancement of any one competency in home based management of febrile seizures among mothers of under five years children |
4 weeks After providing simulation based educational intervention |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
05/08/2026 |
| 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="6"
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 will aim to evaluate the effectiveness of a simulation-linked educational intervention on competencies in the home-based management of febrile seizures among mothers of under-five children. The intervention will include structured teaching supported by a simulation-linked demonstration that will allow mothers to observe and practice essential steps in a realistic environment. Competencies will be assessed before and after the intervention using a self-structured knowledge questionnaire, a Likert scale, and an observational checklist. It is expected that the simulation-linked educational intervention will lead to a significant improvement in the competencies of mothers in managing febrile seizures at home.
|