To educate the medical interns and postgraduates through an educational program about Medical Devices and harmful events it produces and importance about reporting them

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/093979

Enrollment

150

Registered

2025-09-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: An Educational Intervention was given about Materiovigilance between the two groups that is medical interns and postgraduates: Intervention name: Structured educational package on mater

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
The primary outcome was the change in knowledge scores regarding materiovigilance and adverse event reporting of medical devices between the pretest and posttest assessments.Timepoint: 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

Measure	Time frame
Secondary Outcomes included: 1.Change in attitude scores toward materiovigilanceTimepoint: T0 (Baseline Pretest) T1 (Immediate posttest;2. Change in practice scoresTimepoint: T0 (Baseline Pretest) T1 (Immediate posttest);3. Comparison between groups: Difference in magnitude of improvementTimepoint: T0 (Baseline Pretest) T1 (Immediate Posttest);4. Retention of knowledge by follow-up posttest at 4 weeks after the interventionTimepoint: T2 -Retention Posttest (4 weeks after the session);5. Satisfaction/ feedback with the educational interventionTimepoint: T1 (Immediate Posttest)	—

Measure

Time frame

Secondary Outcomes included: 1.Change in attitude scores toward materiovigilanceTimepoint: T0 (Baseline Pretest) T1 (Immediate posttest;2. Change in practice scoresTimepoint: T0 (Baseline Pretest) T1 (Immediate posttest);3. Comparison between groups: Difference in magnitude of improvementTimepoint: T0 (Baseline Pretest) T1 (Immediate Posttest);4. Retention of knowledge by follow-up posttest at 4 weeks after the interventionTimepoint: T2 -Retention Posttest (4 weeks after the session);5. Satisfaction/ feedback with the educational interventionTimepoint: T1 (Immediate Posttest)

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Countries

India

Contacts

Public ContactPRIYANKA S

KIMS Bangalore

drpriyanka110@gmail.com09844093100

Outcome results