NCT07060924

Brief Summary

This randomized controlled study aimed to compare the effectiveness of game-based learning (GBL) and model arm practice in teaching peripheral intravenous cannulation (PIVC) skills to final-year dental students. Sixty participants were randomly assigned to two groups. The impact of each method was assessed in terms of procedural success, anxiety levels (STAI), self-confidence (VAS), and student satisfaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 20, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

July 2, 2025

Last Update Submit

July 11, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Procedural Success Rate in Clinical Application

    The rate of successful intravenous cannulation performed by students on real patients under supervision. Success was defined as a successful puncture and catheter placement on the first or second attempt. Assessed by an anesthesiologist during clinical practice.

    Within 1 week after training

  • Change in Self-Confidence Level (VAS Score)

    Students marked their perceived self-confidence regarding PIVC on a 10-cm visual analog scale (0 = no confidence, 10 = full confidence). Measurements were taken both after training and after clinical application.

    From pre-training to post-clinical application (within 2 weeks)

Secondary Outcomes (2)

  • Change in State Anxiety Level (State-Trait Anxiety Inventory - State Scale)

    Baseline (pre-training), immediately after training, and immediately after clinical application (all within 2 weeks)

  • Satisfaction with Training Method (Likert Questionnaire)

    Immediately after training

Study Arms (2)

Arm A (GBL Group)

EXPERIMENTAL

Training with 3D Medsim game-based platform for intravenous cannulation before patient application

Behavioral: Game-Based Learning (GBL)

Arm B (Model Arm Group)

EXPERIMENTAL

Practical training on a circulation model arm for intravenous cannulation before patient application

Behavioral: Model Arm Practice

Interventions

Participants in this group received practical training in peripheral intravenous cannulation (PIVC) using a game-based learning (GBL) simulation platform called 3D Medsim. The platform offered a scenario-based training environment that included a structured sequence of pre-test, simulated procedural performance, and post-test. Students were required to perform virtual tasks such as preparing the patient, selecting the correct equipment, identifying the puncture site, and performing cannulation. The simulation provided interactive feedback and scoring. The application was accessible via PC, tablet, or smartphone, allowing students to practice flexibly. Training was conducted under the supervision of an anesthesiologist.

Arm A (GBL Group)

Participants in this group practiced PIVC using a high-fidelity model arm simulator designed to replicate human anatomy and venous access. The training model included artificial veins (basilic, cephalic, median cubital, and metacarpal) with realistic skin layers and a circulation system that mimicked blood flow. Students practiced cannulation techniques including vein localization, needle insertion, and catheter placement. The hands-on training provided tactile and visual feedback, and all procedures were supervised by an anesthesiologist. This method aimed to develop psychomotor skills and confidence through realistic simulation.

Arm B (Model Arm Group)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Final-year dental students at Ankara University
  • No prior experience with PIVC
  • Volunteered and provided informed consent

You may not qualify if:

  • Any prior practical experience in intravenous cannulation
  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University, Faculty of Dentistry

Ankara, 06560, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

July 2, 2025

First Posted

July 11, 2025

Study Start

April 20, 2025

Primary Completion

June 15, 2025

Study Completion

June 20, 2025

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations