| CTRI Number |
CTRI/2025/09/095401 [Registered on: 25/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Training program for parents and caregivers to gain confidence in handling seizures in children |
|
Scientific Title of Study
|
Effect of Nurse-led program to improve self-efficacy in managing seizures among caregivers of children at tertiary care institute of Western Rajasthan |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gopal |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
AIIMS JODHPUR |
| Address |
Old Boys Hostel, Room no. 146, College of Nursing, All India Institute of Medical Sciences, Jodhpur Basni Industrial Area, Phase-2
Jodhpur – 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9887780198 |
| Fax |
|
| Email |
joksongopal988778@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Chandra Sharma |
| Designation |
Associate professor |
| Affiliation |
AIIMS JODHPUR |
| Address |
Room no. 110, 1st Floor, Dept. of Pediatric, College of Nursing, All India Institute of Medical Sciences, Jodhpur
Basni Industrial Area, Phase-2
Jodhpur – 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9779534307 |
| Fax |
|
| Email |
sharmamukeshchandra@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Raghu VA |
| Designation |
Tutor and Clinical Instructor (Nursing) |
| Affiliation |
AIIMS JODHPUR |
| Address |
Room no. 112, 1st Floor, Dept. of Pediatric, College of Nursing, All India Institute of Medical Sciences, Jodhpur
Basni Industrial Area, Phase-2
Jodhpur – 342005
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8447007616 |
| Fax |
|
| Email |
raghuva84@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Gopal |
| Address |
College of Nursing, All India Institute of Medical Sciences, Jodhpur
Basni Industrial Area, Phase-2
Jodhpur – 342005 |
| Type of Sponsor |
Other [] |
|
|
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 Mukesh Chandra Sharma |
All India Institute of Medical Sciences, Jodhpur |
2D IPD, PICU AND Pediatric OPD, All India Institute of Medical Sciences, Jodhpur
Basni Industrial Area, Phase-2
Jodhpur – 342005
Jodhpur
RAJASTHAN |
9779534307
sharmamukeshchandra@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
caregivers of children who have at least one episode of seizure |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse-led program |
Caregivers in the experimental group will receive a nurse-led program consisting of Simulation-based education session 40 to 45 minutes covering recognition of seizures, first aid management, post-seizure care, safety measures, and administration of rescue medication.
Educational booklet on seizure management provided after the session for reinforcement.
The intervention will be delivered in Pediatric OPD and ward at AIIMS Jodhpur by the investigator. |
| Comparator Agent |
Routine discharge instructions |
Caregivers in the control group will receive standard discharge instructions routinely provided at the hospital regarding seizure management in children, without structured simulation training or booklet support. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Caregivers who are
1.Aged 18 to 60 years and are the primary caregiver of the child.
2.Caring for children aged 1 to 18 years with seizures.
3.Willing to participate and provide written informed consent. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
1.Caregivers of children with other chronic co-morbid conditions.
2.Caregivers with known psychiatric illnesses or cognitive impairments. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in self-efficacy of caregivers in managing seizures, measured using the KidSIM-ASPIRE Parent Seizure Self-Efficacy Questionnaire (pre-test vs. post-test in experimental and control groups). |
Baseline (Pre-test)
Before the intervention, both experimental and control groups will complete the KidSIM-ASPIRE Parent Seizure Self-Efficacy Questionnaire.
Intervention Phase
Experimental group: Receives nurse-led program (simulation-based education + booklet, ~40–45 minutes).
Control group: Receives routine discharge instructions.
Post-test
After 1 week of intervention, self-efficacy will be reassessed in both groups using the same tool. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between demographic variables and self-efficacy |
Baseline (pre-test, before intervention)
Immediate post-intervention (right after the simulation session) — for skills & satisfaction
Post-test at 1 week after intervention — secondry outcome (self-efficacy) and knowledge recall |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/10/2025 |
| 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
|
This study aims to evaluate the effectiveness of a nurse-led program (simulation-based education and educational booklet) in improving self-efficacy among caregivers of children with seizures at a tertiary care institute in Western Rajasthan.
The primary hypothesis is that caregivers who undergo the nurse-led program will demonstrate a significant improvement in self-efficacy scores (measured by the KidSIM-ASPIRE Parent Seizure Self-Efficacy Questionnaire) compared to those receiving routine discharge instructions.
Secondary objectives include examining the association between caregivers’ demographic variables and their self-efficacy scores. |