NCT06714474

Brief Summary

The goal of this randomized controlled trial is to evaluate the effectiveness of the Virtual Simulation Game (VSG) method in teaching venous blood sampling (VBS) skills to second-year nursing students. The study aims to provide a safe, engaging, and innovative learning environment for nursing students, enabling them to improve their skills without compromising patient safety. The main questions the study seeks to answer are: Does VSG training improve nursing students' knowledge levels in VBS education? Does VSG training enhance nursing students' practical performance in VBS procedures? Does VSG training increase nursing students' satisfaction with VBS education? Does VSG training boost nursing students' confidence in performing VBS? Does VSG training enhance nursing students' comfort during VBS practice? Researchers will compare the Virtual Simulation Game (VSG) method to the standard technique. In the VSG group, students will engage with an interactive simulation game to practice VBS skills virtually before applying them in a clinical setting. In the control group, students will practice VBS skills using traditional methods in a laboratory environment. Participants' Tasks: Students in the VSG group will: Log in to the simulation platform with their credentials. Complete interactive training scenarios that mimic real-life challenges in venous blood sampling. Practice the procedure on their peers under supervision. Students in the control group will: Practice VBS directly on their peers under supervision without using simulation. After practicing, all students will be observed for 15 minutes by expert nurses for potential complications or discomfort. If needed, participants will receive medical care. This study adheres to the CONSORT guidelines for randomized controlled trials and incorporates validated instruments to measure knowledge, skill performance, satisfaction, confidence, and comfort levels among participants. The findings aim to bridge the gap in nursing education by introducing an innovative, technology-driven approach to skill training.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 3, 2024

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

1 month

First QC Date

November 27, 2024

Last Update Submit

November 27, 2024

Conditions

Keywords

Nursing EducationVirtual Simulation GameNursing StudentsVenous Blood Sampling

Outcome Measures

Primary Outcomes (2)

  • Venous Blood Sampling Knowledge Form

    Change in participants' knowledge of venous blood sampling procedures, assessed via a validated questionnaire.

    Pre-intervention (baseline) and post-intervention (immediately after training).

  • Venous Blood Sampling Application Checklist

    Evaluation of participants' practical skills in venous blood sampling using a structured observational checklist.

    Pre-intervention (baseline) and post-intervention (immediately after training).

Secondary Outcomes (2)

  • Student Satisfaction and Self-Confidence in Learning Scale

    Pre-intervention (baseline) and post-intervention (immediately after training).

  • Visual Comparison (Comfort) Scale

    Pre-intervention (baseline) and post-intervention (immediately after training).

Study Arms (2)

Virtual Simulation Game Group

EXPERIMENTAL

Participants in this arm will receive traditional training on venous blood sampling (VBS), including theoretical instruction and hands-on practice in a laboratory setting. Additionally, they will use a Virtual Simulation Game (VSG) platform (http://www.hemsirelab.com) to enhance their learning through interactive, scenario-based training. After logging into the VSG platform with unique credentials, participants will complete the training scenarios to refine their skills before performing the procedure on peers under supervision.

Other: Virtual Simulation GameOther: Traditional Training

Traditional Education Group

ACTIVE COMPARATOR

Participants in this arm will receive traditional training on venous blood sampling (VBS) in a laboratory setting. They will observe demonstrations and practice the procedure on peers without the use of virtual simulation

Other: Traditional Training

Interventions

The Virtual Simulation Game (VSG) is an interactive, scenario-based digital training tool designed to enhance venous blood sampling (VBS) skills. Participants engage with the VSG platform to complete modules that simulate real-life clinical scenarios, allowing them to refine decision-making and procedural skills in a safe, controlled environment. This intervention is used in addition to traditional training to reinforce learning through repetition and feedback.

Virtual Simulation Game Group

Traditional training consists of theoretical instruction and hands-on practice sessions conducted in a laboratory setting. Participants observe VBS demonstrations, followed by supervised practice on peers to develop their procedural skills. This intervention represents the standard educational approach for VBS and serves as the comparator in this study.

Traditional Education GroupVirtual Simulation Game Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled in the "Principles and Applications in Nursing" course, specifically the "Fundamentals of Nursing Care" module, for the first time.
  • No prior clinical experience. No prior experience with venous blood sampling. No prior education in health sciences (e.g., not a graduate of a vocational health school or a health-related associate degree program).
  • Willing to voluntarily participate in the study.

You may not qualify if:

  • Diagnosed with a chronic illness, bleeding disorder, or psychiatric condition. Pregnant students. Students who have not received Hepatitis A or Hepatitis B vaccines. Students who fail to complete the study data collection forms. Students who withdraw their consent to participate during the study. Students who are absent at any stage of the study process. Students who do not complete the simulation training sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Faculty of Nursing Simulation Laboratory

Izmir, İzmir, 35000, Turkey (Türkiye)

RECRUITING

Related Publications (7)

  • Plebani M. Errors in clinical laboratories or errors in laboratory medicine? Clin Chem Lab Med. 2006;44(6):750-9. doi: 10.1515/CCLM.2006.123.

    PMID: 16729864BACKGROUND
  • Maheu-Cadotte, M., et al. (2020). Designing effective educational games for nursing education. Nurse Education Today, 92, 104490.

    BACKGROUND
  • Luctkar-Flude, M., et al. (2021). Virtual simulation in nursing education: A systematic review. Journal of Nursing Education, 60(6), 319-325.

    BACKGROUND
  • Keys, M. D., et al. (2020). Simulation in nursing education: An integrative review. Nursing Education Perspectives, 41(2), 83-89.

    BACKGROUND
  • Green, S. F. (2013). The cost of preanalytical errors. Clinical Laboratory News, 39(5), 1-5.

    BACKGROUND
  • Foronda, C. (2021). The effectiveness of virtual simulation in nursing education. Nurse Educator, 46(3), 124-130.

    BACKGROUND
  • Alcantara, C. S., et al. (2022). Preanalytical errors in venous blood sampling. Journal of Clinical Pathology, 75(4), 217-224.

    BACKGROUND

Central Study Contacts

Turgay Yalcinkaya, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Masking Description In this study, outcomes assessors are blinded to the group assignments to reduce bias in evaluating participants' performance, satisfaction, confidence, and comfort levels. Participants and care providers are not blinded due to the nature of the interventions, as the experimental group engages with a Virtual Simulation Game (VSG) platform that is distinguishable from the standard teaching method used in the control group. No other parties are masked in this trial.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Model Description In this randomized controlled trial, participants are assigned to one of two parallel groups: Experimental Group: Participants receive training using a Virtual Simulation Game (VSG) for venous blood sampling (VBS) skills. Control Group: Participants receive traditional training methods for VBS skills. The interventions are applied concurrently, and the outcomes (knowledge, skill performance, satisfaction, confidence, and comfort) are compared between the two groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2024

First Posted

December 3, 2024

Study Start

November 1, 2024

Primary Completion

December 15, 2024

Study Completion

December 31, 2024

Last Updated

December 3, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
01.01.2025 - 01.02.2025
Access Criteria
A signed data sharing agreement ensuring data confidentiality and adherence to ethical standards.

Locations