Simulation-based EducationNCT07678190
High-Fidelity Simulation in Vaccination Training
A study testing High-Fidelity Simulation and Standard Laboratory Practice in people with Simulation-based Education and Vaccination Training, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Simulation-based Education, Vaccination Training, Education Nursing
- What is being tested?
- High-Fidelity Simulation and Standard Laboratory Practice
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 1 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fourth-year nursing students
- Voluntary participation
Who cannot join
- Did not complete post-tests
- Non-volunteering
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bulent Ecevit University
Kozlu, Zonguldak Province, 67600
About this study
Official title: 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.
Read the 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.
- Being tested
- High-Fidelity Simulation, Standard Laboratory Practice
- Keywords
- vaccine hesitancy, high-fidelity simulation, nursing students, ımmunization, knowledge, skill
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Fidelity SimulationBehavioural
High-fidelity simulation-based training including a vaccine hesitancy scenario, structured briefing, simulation, and debriefing.
Standard Laboratory PracticeBehavioural
Traditional laboratory-based vaccination training using a manikin without a structured simulation scenario.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard Laboratory Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 hour after training
Secondary outcomes (2)
Student Satisfaction and Self-Confidence in Learning Scale (SCLS)
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.
Measured: 1 hour after training
Simulation Design Scale (SDS)
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.
Measured: 1 hour after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Nov 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Simulation-based EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental Group: High-Fidelity Simulation (HFS) Control Group: Standard Laboratory Practice (SLP)
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Signem ANOL KILIÇ, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678190
- Sponsor's protocol ID
- 205926
- Status last verified
- Jun 2026
- First submitted
- 21 Apr 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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
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.
PubMed 37657119Costa 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.
PubMed 32578755
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-fidelity Simulation on Childhood Vaccination Training in Nursing Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07678190
- Acronym / sponsor ID
- 205926
- Keywords
- vaccine hesitancy, high-fidelity simulation, nursing students, ımmunization, knowledge, skill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental Group: High-Fidelity Simulation (HFS) Control Group: Standard Laboratory Practice (SLP)
| Arm | Type | Receives |
|---|---|---|
| High-Fidelity Simulation Group (HFS) | Experimental | Behavioral: High-Fidelity SimulationThe 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. |
| Standard Laboratory Practice Group (SLP) | Active comparator | Behavioral: Standard Laboratory PracticeThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fourth-year nursing students
- Voluntary participation
Key exclusion criteria (2 listed)
- Did not complete post-tests
- Non-volunteering
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Fidelity SimulationHigh-fidelity simulation-based training including a vaccine hesitancy scenario, structured briefing, simulation, and debriefing. | Behavioural | High-Fidelity Simulation Group (HFS) |
| Standard Laboratory PracticeTraditional laboratory-based vaccination training using a manikin without a structured simulation scenario. | Behavioural | Standard Laboratory Practice Group (SLP) |
Primary outcome
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.
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.
2 secondary outcomes
Student Satisfaction and Self-Confidence in Learning Scale (SCLS)
Time frame: 1 hour after training
Simulation Design Scale (SDS)
Time frame: 1 hour after training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Results publicationNelson, 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
- Results publication: PubMed 37657119Hekel 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.
- Results publication: PubMed 32578755Costa 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Fidelity Simulation and Standard Laboratory Practice in people with Simulation-based Education and Vaccination Training, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childhood Immunization Knowledge Test (CIKT) (time frame: Baseline, 1 hour after training, and 1 month after training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07678190, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 28 Oct 2026.