High-Fidelity Simulation in Vaccination Training

NCT07678190 | Completed

• 1 other identifier: 205926
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Simulation-based Education; Vaccination Training; Education Nursing

Keywords

vaccine hesitancy; high-fidelity simulation; nursing students; ımmunization; knowledge; skill

Outcome Measures

Primary Outcomes (2)

• Childhood Immunization Knowledge Test (CIKT)

  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)

  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 Outcomes (2)

• Student Satisfaction and Self-Confidence in Learning Scale (SCLS)

  1 hour after training

• Simulation Design Scale (SDS)

  1 hour after training

Study Arms (2)

High-Fidelity Simulation Group (HFS)

EXPERIMENTAL

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

Standard Laboratory Practice Group (SLP)

ACTIVE COMPARATOR

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

Interventions

High-Fidelity Simulation BEHAVIORAL

High-fidelity simulation-based training including a vaccine hesitancy scenario, structured briefing, simulation, and debriefing.

High-Fidelity Simulation Group (HFS)

Standard Laboratory Practice BEHAVIORAL

Traditional laboratory-based vaccination training using a manikin without a structured simulation scenario.

Standard Laboratory Practice Group (SLP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fourth-year nursing students
• Voluntary participation

You may not qualify if:

• Did not complete post-tests
• Non-volunteering

Sponsors & Collaborators

• Zonguldak Bulent Ecevit University: lead

Study Sites (1)

Zonguldak Bulent Ecevit University

Kozlu, Zonguldak Province, 67600, Turkey (Türkiye)

Location

Related Publications (3)

• Nelson, B., Ridgway, J., Brown, A., Anthamatten, A., Hall, E., & McClure, N. (2025). Interactive simulation for addressing vaccine hesitancy in nurse practitioner education. Clinical Simulation in Nursing,102, 101719. https://doi.org/10.1016/j.ecns.2025.101719

  RESULT

• Hekel BE, Dugger J, Pullis BR, Cron S, Edwards AP. Vaccine Hesitancy: Developing Competency in Nursing Students Through Simulation. Nurse Educ. 2024 Mar-Apr 01;49(2):E62-E67. doi: 10.1097/NNE.0000000000001505. Epub 2023 Sep 1.

  PMID: 37657119 RESULT

• Costa RRO, Medeiros SM, Martins JCA, Coutinho VRD, Araujo MS. Effectiveness of simulation in teaching immunization in nursing: a randomized clinical trial. Rev Lat Am Enfermagem. 2020 Jun 19;28:e3305. doi: 10.1590/1518-8345.3147.3305. eCollection 2020.

  PMID: 32578755 RESULT

MeSH Terms

Conditions

Vaccination Hesitancy

Condition Hierarchy (Ancestors)

Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Experimental Group: High-Fidelity Simulation (HFS) Control Group: Standard Laboratory Practice (SLP)

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: July 1, 2026
• Study Start: November 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

TU (1)