| CTRI Number |
CTRI/2025/09/094522 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Structured Educational Intervention] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Structured Educational Program to improve the knowledge, attitude and practice of monitoring medicine safety and preventing harm to patients |
|
Scientific Title of Study
|
Effect of structured educational intervention on knowledge, attitude and practice of pharmacovigilance among nursing students in a Tertiary Hospital, Puducherry – One group pre-test and post-test design |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mandira Saha |
| Designation |
M.Sc. Nursing Student |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
College of Nursing, Community Health Nursing Departemnt, Jawaharlal Institute of Postgraduate Medical Education and Research
Dhanvantari Nagar Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8013063482 |
| Fax |
|
| Email |
sahamandira1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr R S Ramesh |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
College of Nursing, Community Health Nursing Department, 1st floor, Jawaharlal Institute of Postgraduate Medical Education and Research
Dhanvantari Nagar Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9488084456 |
| Fax |
|
| Email |
rameshjipmer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr R S Ramesh |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
College of Nursing, Community Health Nursing Department, 1st floor, Jawaharlal Institute of Postgraduate Medical Education and Research
Dhanvantari Nagar, Puducherry 605006
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9488084456 |
| Fax |
|
| Email |
rameshjipmer@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Fund Committee, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Intramural Fund Committee, Jawaharlal Institute of Postgraduate Medical Education and Research
Dhanvantari Nagar Puducherry 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mandira Saha |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Multipurpose Hall, Community Health Nursing Department, College of Nursing, JIPMER, Puducherry 605006
Pondicherry
PONDICHERRY |
8013063482
sahamandira1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age group of 20-31 years healthy boys and girls of B.SC Nursing 2nd, 3rd and 4th year students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Structured educational intervention |
Structured teaching will be provided through a PowerPoint presentation on pharmacovigilance and ADR reporting. On the same day of pretest , structured teaching will be given to students for 45-60 minutes and a handout will be distributed to students after structured teaching |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
31.00 Year(s) |
| Gender |
Both |
| Details |
Healthy boys and girls of age between 20 years to 31 years of B.Sc Nursing 2nd, 3rd and 4th year students |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of structured educational intervention on knowledge, attitude, and practice of pharmacovigilance among nursing students. |
4 weeks after structured educational intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the association between socio-demographic factors with knowledge, attitude, and practice of pharmacovigilance among nursing students. |
1st day and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="276"
Sample Size from India="276"
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)
|
22/09/2025 |
| 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="1"
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 aims to assess the knowledge, attitude, and practice of pharmacovigilance among nursing students and to encourage their active participation in ADR reporting and safe medication practices. Pre-test will be held by using the pretested and validated questionnaire containing 20 items related to KAP on pharmacovigilance and then structured teaching will be
held for 45-60 minutes on the same day of pretest through PowerPoint presentation to update their knowledge and a handout will be distributed to them. After the structured teaching, their knowledge, attitude, and practice will be reassessed one month after the pretest through the same pre-tested semi-structured
questionnaire.
Pre test and post test knowledge, attitude, and practice will be compared to assess the effect of structured teaching.
Socio-demographic variables associated with knowledge, attitude, practice will be assessed.
Hypothesis -Structured teaching will improve the knowledge, attitude and practice of pharmacovigilance and ADR reporting among the nursing students. |