Dental Education and Special Care DentistryNCT07060924
Comparison of Game-Based Learning and Model Arm Practice for Teaching Intravenous Cannulation to Dental Students
A study testing Game-Based Learning (GBL) and Model Arm Practice in people with Dental Education and Special Care Dentistry, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dental Education and Special Care Dentistry
- What is being tested?
- Game-Based Learning (GBL) and Model Arm Practice
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2025to 20 Jun 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Final-year dental students at Ankara University
- No prior experience with PIVC
- Volunteered and provided informed consent
Who cannot join
- Any prior practical experience in intravenous cannulation
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University, Faculty of Dentistry
Ankara, 06560
About this study
Official title: Evaluation of Dental Students' Attitudes and Behaviors Toward Intravenous Cannulation: A Comparative Study of Game-Based Learning and Model Arm Practice
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.
Read the detailed description
Peripheral intravenous cannulation (PIVC) is a complex procedure now integrated into the Turkish National Dental Curriculum (DUÇEP). This study compared the effectiveness of GBL using the 3D Medsim platform and model arm practice in training students on PIVC. Participants were final-year dental students with no prior PIVC experience. Pre- and post-intervention evaluations included procedural success (simulation or model), anxiety (STAI), self-confidence (VAS), and satisfaction (Likert scale). Clinical success was also monitored.
- Being tested
- Game-Based Learning (GBL), Model Arm Practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game-Based Learning (GBL)Behavioural
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.
Model Arm PracticeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (GBL Group) | Experimental | Training with 3D Medsim game-based platform for intravenous cannulation before patient application Receives: Behavioral: Game-Based Learning (GBL) |
| Arm B (Model Arm Group) | Experimental | Practical training on a circulation model arm for intravenous cannulation before patient application Receives: Behavioral: Model Arm Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From pre-training to post-clinical application (within 2 weeks)
Secondary outcomes (2)
Change in State Anxiety Level (State-Trait Anxiety Inventory - State Scale)
Anxiety was measured using the State-Trait Anxiety Inventory - State Scale (STAI-S), a validated 20-item questionnaire assessing situational anxiety. Each item is rated on a 4-point Likert scale, yielding total scores ranging from 20 to 80, where higher scores indicate higher levels of anxiety (i.e., a worse psychological outcome).
Measured: Baseline (pre-training), immediately after training, and immediately after clinical application (all within 2 weeks)
Satisfaction with Training Method (Likert Questionnaire)
A 5-item satisfaction questionnaire evaluated participants' perceptions of the training method's usefulness, content diversity, presentation, motivation, and compatibility with learning style. Each item was scored on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree)
Measured: Immediately after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start20 Apr 2025
- Primary completion15 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Education and Special Care DentistryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagil Vural, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060924
- Sponsor's protocol ID
- AnkaraU 8/23
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dental Students' Attitudes and Behaviors Toward Intravenous Cannulation: A Comparative Study of Game-Based Learning and Model Arm Practice
- ClinicalTrials.gov ID
- NCT07060924
- Acronym / sponsor ID
- AnkaraU 8/23
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 11 Jul 2025 (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 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.
Detailed description
Peripheral intravenous cannulation (PIVC) is a complex procedure now integrated into the Turkish National Dental Curriculum (DUÇEP). This study compared the effectiveness of GBL using the 3D Medsim platform and model arm practice in training students on PIVC. Participants were final-year dental students with no prior PIVC experience. Pre- and post-intervention evaluations included procedural success (simulation or model), anxiety (STAI), self-confidence (VAS), and satisfaction (Likert scale). Clinical success was also monitored.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (GBL Group) | Experimental | Behavioral: Game-Based Learning (GBL)Training with 3D Medsim game-based platform for intravenous cannulation before patient application |
| Arm B (Model Arm Group) | Experimental | Behavioral: Model Arm PracticePractical training on a circulation model arm for intravenous cannulation before patient application |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Final-year dental students at Ankara University
- No prior experience with PIVC
- Volunteered and provided informed consent
Key exclusion criteria (2 listed)
- Any prior practical experience in intravenous cannulation
- Refusal to participate
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 |
|---|---|---|
| Game-Based Learning (GBL)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. | Behavioural | Arm A (GBL Group) |
| Model Arm PracticeParticipants 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. | Behavioural | Arm B (Model Arm Group) |
Primary outcome
Procedural Success Rate in Clinical Application
Time frame: Within 1 week after training
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.
Change in Self-Confidence Level (VAS Score)
Time frame: From pre-training to post-clinical application (within 2 weeks)
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.
2 secondary outcomes
Change in State Anxiety Level (State-Trait Anxiety Inventory - State Scale)
Time frame: Baseline (pre-training), immediately after training, and immediately after clinical application (all within 2 weeks)
Satisfaction with Training Method (Likert Questionnaire)
Time frame: Immediately 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 16 Jul 2025.
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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 Game-Based Learning (GBL) and Model Arm Practice in people with Dental Education and Special Care Dentistry, run by Ankara 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 3 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 16 Jul 2025. 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?
Procedural Success Rate in Clinical Application (time frame: Within 1 week 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?
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 16 Jul 2025.