- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07678190
High-Fidelity Simulation in Vaccination Training
The Effect of High-fidelity Simulation on Childhood Vaccination Training in Nursing Students: A Randomized Controlled Trial
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Zonguldak Province
-
Kozlu, Zonguldak Province, 터키 (Türkiye), 67600
- Zonguldak Bulent Ecevit University
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Fourth-year nursing students
- Voluntary participation
Exclusion Criteria:
- Did not complete post-tests
- Non-volunteering
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
|
High-fidelity simulation-based training including a vaccine hesitancy scenario, structured briefing, simulation, and debriefing.
|
|
활성 비교기: 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.
|
Traditional laboratory-based vaccination training using a manikin without a structured simulation scenario.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Childhood Immunization Knowledge Test (CIKT)
기간: 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)
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Student Satisfaction and Self-Confidence in Learning Scale (SCLS)
기간: 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)
기간: 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
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 205926
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .