| CTRI Number |
CTRI/2025/09/093979 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational intervention. Quasi-experimental, comparative pretest-posttest study] |
| Study Design |
Other |
|
Public Title of Study
|
To educate the medical interns and postgraduates through an educational program about Medical Devices and harmful events it produces and importance about reporting them |
|
Scientific Title of Study
|
Evaluation Of Educational Intervention To Create Awareness about Adverse Event Reporting Of Medical Devices among Medical Interns and Post graduates in a tertiary care Hospital-A Quasi-Experimental Pre-Test Post-test Study |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRIYANKA S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KIMS Bangalore |
| Address |
136/A, E ROAD, RR NAGAR, BANGALORE
Banashankari 2nd Stage Bangalore-560070
Bangalore
KARNATAKA
560098
India |
| Phone |
09844093100 |
| Fax |
|
| Email |
drpriyanka110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PRIYANKA S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KIMS Bangalore |
| Address |
136/A, E ROAD, RR NAGAR, BANGALORE
Banashankari 2nd Stage Bangalore-560070
KARNATAKA
560098
India |
| Phone |
09844093100 |
| Fax |
|
| Email |
drpriyanka110@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRIYANKA S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
KIMS Bangalore |
| Address |
136/A, E ROAD, RR NAGAR, BANGALORE
Banashankari 2nd Stage Bangalore-560070
KARNATAKA
560098
India |
| Phone |
09844093100 |
| Fax |
|
| Email |
drpriyanka110@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kempegowda Institute Of Medical Sciences, Banashankari 2nd stage, Bangalore-560070 |
|
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Primary Sponsor
|
| Name |
PRIYANKA S |
| Address |
Associate Professor, Department of Pharmacology,
KIMS, Banashankari 2nd Stage Bangalore-560070 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr PRIYANKA S |
KIMS Bangalore |
Department of Pharmacology, 3rd floor, 6th room, Banashankari 2nd Stage Bangalore
Bangalore
KARNATAKA |
09844093100
drpriyanka110@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kempegowda Institute Of Medical Sciences, Bangalore |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
An Educational Intervention was given about Materiovigilance between the two groups that is medical interns and postgraduates |
Intervention name: Structured educational package on materiovigilance
Type: Behavioral/Educational intervention
Description: A single, structured session covering
1. Overview of materiovigilance and regulatory framework
2. Identification and classification of adverse events
3. how/when to report
4. Hands-on demonstration of the reporting form/online portal
5. Case vignettes and brief quiz with feedback
Mode of delivery: In person clasroom (projected slides + live demo) or hybrid (live webinar + screen-share demo), facilitated by pharmacology/materiovigilance faculty |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Population: Medical Interns and Postgraduate residents currently posted at the tertiary-care hospital during the study period
2. Departmental scope: Participants from clinical, paraclinical, or preclinical medical departments
3. Availability: Able to attend the educational session and both assessments(pretest and posttest within the specified post-intervention window(1-2 weeks
4. Consent: Provides written informed consent.
5. Language/format: Comfortable with the language of instruction and questionnaire format used in the study
|
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| ExclusionCriteria |
| Details |
1. Prior formal training/ exposure: Attended a dedicated workshop/course/seminar focused on materiovigilance in the past 6-12 months
2. Role conflict: Members of the Institutional Materiovigilance Committee or those actively involved in device safety surveillance/teaching
3. Non-medical cadres: Nursing, Dental, Physiotherapy, Allied-Health students/staff, administrative personnel, and faculty
4. Non-participation/attrition: Declines consent, absent for the educational session, Incomplete data, logistical exclusion |
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome was the change in knowledge scores regarding materiovigilance and adverse event reporting of medical devices between the pretest and posttest assessments. |
T0-Pretest (Baseline): Immediately before the educational session (same day, within 0-30 min before start)
T1-Immediate Posttest (Primary endpoint) Right after the session (same day, within 0-30 min of completion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcomes included:
1.Change in attitude scores toward materiovigilance |
T0 (Baseline Pretest)
T1 (Immediate posttest |
| 2. Change in practice scores |
T0 (Baseline Pretest)
T1 (Immediate posttest) |
| 3. Comparison between groups: Difference in magnitude of improvement |
T0 (Baseline Pretest)
T1 (Immediate Posttest) |
| 4. Retention of knowledge by follow-up posttest at 4 weeks after the intervention |
T2 -Retention Posttest (4 weeks after the session) |
| 5. Satisfaction/ feedback with the educational intervention |
T1 (Immediate Posttest) |
|
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Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="0"
Days="15" |
|
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
|
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Brief Summary
|
Materiovigilance, the systematic monitoring of adverse events related to medical devices, is an essential component of patient safety. Awareness among healthcare professionals, especially interns and postgraduate residents, remains suboptimal. Educational interventions may improve knowledge, attitude and practice (KAP) regarding device safety reporting. |