Immunisation Simulation Using the Real-size Infant Manikin in Medical Education

• Sponsor: Indonesia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05389020
• Collaborator: (none)
• Enrollment: 205
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 29.6

Study Details

Study Description

Brief Summary

This was a quasi-experimental study that comprised medical students in pediatric rotation at the Faculty of Medicine, Universitas Indonesia, Jakarta. The investigators determined students' knowledge and practice improvement through simulation by using the real-size infant's arm and leg manikins; and evaluate the confidence in immunization after the simulation.

Condition or Disease	Intervention/Treatment	Phase
Immunization Skills	Other: Newly developed real-size infant's arm and leg manikin	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 205 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Immunisation Simulation Using the Real-size Infant Manikin in Medical Education
• Actual Study Start Date: Oct 1, 2020
• Actual Primary Completion Date: Apr 30, 2021
• Actual Study Completion Date: Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group 70 minutes course using newly developed real-size infant's arm and leg manikin	Other: Newly developed real-size infant's arm and leg manikin; The control group used conventional manikins made by Nasco; meanwhile, two newly designed real-size manikins were prepared for the intervention group: the right arm and right leg. Real-size manikins were developed based on the mean of anthropometric measurement of 50 Indonesian infants' arms and legs of healthy term neonates born in Dr Cipto Mangunkusumo Hospital. The manikins were made of Thermoplastic Polyurethane (TPU) filament using three-dimensional (3D) printing technology. The manufacturing process was carried out by the Medical Physics Department, Universitas Indonesia.
No Intervention: Control group 70 minutes course using conventional manikin

Outcome Measures

Primary Outcome Measures

1. Knowledge pre- and post-test questionnaire [Seven weeks after the immunization course]

   The improvement of students' knowledge by using the real-size infant's arm and leg manikins

2. Practical skill score using rubric [Seven weeks after the immunization course]

   The improvement of students' practical skill by using the real-size infant's arm and leg manikins

3. Number of students who were confident by self assessment using Likert scale questionnaire [Seven weeks after the immunization course]

   The confidence in doing the immunization practice after the workshop

4. Students' feedback questionnaire [Seven weeks after the immunization course]

   Students' response and feedback regarding the practice using the real-size infant's arm and leg manikins

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Medical students in paediatric rotation at the Faculty of Medicine, Universitas Indonesia, Jakarta

• Medical students who attended immunisation workshops

Exclusion Criteria:

• Students who refused to participate

• Students who did not attend the immunisation workshops

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Cipto Mangunkusumo Hospital	Jakarta Pusat		Indonesia	10430

Sponsors and Collaborators

• Indonesia University

Investigators

• Principal Investigator: Hartono Gunardi, MD, PhD, Indonesia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Hartono Gunardi, MD, PhD, Prof, Indonesia University
• ClinicalTrials.gov Identifier: NCT05389020
• Other Study ID Numbers: 653/UN2.F1/ETIK/PPM.00.02
• First Posted: May 24, 2022
• Last Update Posted: May 24, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Prof. Hartono Gunardi, MD, PhD, Prof, Indonesia University: Simulation; Manikin; Immunization; Vaccination

Study Results

No Results Posted as of May 24, 2022