High-Fidelity Simulation in Vaccination Training

June 24, 2026 updated by: Signem ANOL KILIÇ, Zonguldak Bulent Ecevit University

The Effect of High-fidelity Simulation on Childhood Vaccination Training in Nursing Students: A Randomized Controlled Trial

This study compared the impact of high-fidelity simulation (HFS) versus standart laboratory practice (SLP) on nursing students' knowledge, psychomotor skills, learning satisfaction, and self-confidence within a childhood vaccination training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial evaluated the effectiveness of high-fidelity simulation (HFS) versus standard laboratory practice (SLP) on nursing students' knowledge, psychomotor skills, satisfaction, and self-confidence in childhood vaccination training. A total of 122 fourth-year nursing students were randomly assigned to HFS or SLP groups; 104 completed the study.

All participants received the same theoretical training on childhood immunization. The HFS group participated in a simulation scenario involving vaccine hesitancy, while the SLP group performed traditional laboratory-based practice on a manikin.

Knowledge was assessed using a pre-test, post-test at 1 hour, and a one-month follow-up test. Skills were evaluated immediately after the intervention. Satisfaction and self-confidence were also measured post-intervention.

The primary outcomes were knowledge and skill performance, while secondary outcomes included satisfaction and self-confidence. The study was conducted in accordance with ethical standards, and informed consent was obtained from all participants.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Zonguldak Province
      • Kozlu, Zonguldak Province, Turkey (Türkiye), 67600
        • Zonguldak Bulent Ecevit University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Fourth-year nursing students
  • Voluntary participation

Exclusion Criteria:

  • Did not complete post-tests
  • Non-volunteering

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-Fidelity Simulation Group (HFS)
The HFS intervention was developed in accordance with INACSL Healthcare Simulation Standards and validated by six nursing experts. All participants first received a standardized 100-minute childhood vaccination training consisting of theoretical instruction and laboratory practice. The simulation session included a 10-minute briefing, a 20-minute high-fidelity scenario involving a vaccine-hesitant mother, and a 30-minute structured debriefing using the PEARLS framework. During the simulation, students were required to assess parental concerns, provide education, safely administer vaccines, and complete documentation. The debriefing process included reflection and analysis through structured phases to enhance learning outcomes.
Behavioral: High-Fidelity Simulation
High-fidelity simulation-based training including a vaccine hesitancy scenario, structured briefing, simulation, and debriefing.
Active Comparator: Standard Laboratory Practice Group (SLP)
The SLP group received the identical 100-minute theoretical and practical training session. One week later, instead of a structured simulation, they participated in a 20-minute individual skills session in the nursing fundamentals laboratory. Each student independently performed the vaccination procedure on a baby manikin and verbally described the parent education they would provide. Following their session, each student also participated in an individual, video-assisted PEARLS debriefing focused on their technical performance and communication description.
Behavioral: Standard Laboratory Practice
Traditional laboratory-based vaccination training using a manikin without a structured simulation scenario.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Childhood Immunization Knowledge Test (CIKT)
Time Frame: Baseline, 1 hour after training, and 1 month after training
A 10-item multiple-choice test developed by the researchers based on national guidelines and literature. Each correct answer is scored as 10 points. Total scores range from 0 to 100, with higher scores indicating greater knowledge of childhood immunization. Expert validation was obtained, and the KR-20 reliability coefficient was 0.93.
Baseline, 1 hour after training, and 1 month after training
Pediatric Intramuscular Vaccination Administration Checklist (PIVAC)
Time Frame: 1 hour after training
Items are scored from 0 (not performed) to 2 (performed). Total scores range from 0 to 40, with higher scores indicating better pediatric intramuscular vaccination administration skills. The checklist demonstrated expert validity and a Cronbach's alpha of 0.90.
1 hour after training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Student Satisfaction and Self-Confidence in Learning Scale (SCLS)
Time Frame: 1 hour after training
A validated 12-item, 5-point Likert scale with two subscales (Satisfaction and Self-Confidence). Total scores range from 12 to 60, with higher scores indicating greater satisfaction and self-confidence in learning. In this study, Cronbach's alpha was 0.96 for the satisfaction subscale, 0.94 for the self-confidence subscale, and 0.96 for the total scale.
1 hour after training
Simulation Design Scale (SDS)
Time Frame: 1 hour after training
The Simulation Design Scale consists of 20 items rated on a 5-point Likert scale. Total scores range from 20 to 100, with higher scores indicating a more positive evaluation of the simulation design. Cronbach's alpha was 0.98.
1 hour after training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zonguldak Bulent Ecevit University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

June 24, 2026

First Posted (Actual)

July 1, 2026

Study Record Updates

Last Update Posted (Actual)

July 1, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205926

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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