- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07583537
Augmented Reality and 3D Model-Based Ventrogluteal Injection Training in Nursing Students (AR3D-VGI) (AR3D-VGI)
Effect of Ventrogluteal Injection Training Using Augmented Reality and a 3D Model on Nursing Students' Knowledge, Skills, Anxiety and Satisfaction
The aim of this study was to evaluate the impact of a skills training program-conducted using augmented reality (AR) and 3D model technologies-on first-year nursing students' knowledge, skills, anxiety, and satisfaction, as well as the retention of learning, regarding the correct identification of the injection site and the application of the correct technique for intramuscular (IM) injections in the deltoid (VG) region. The hypotheses of the study are as follows:
H1: There is a difference in knowledge scores regarding the administration of intramuscular injections into the ventrogluteal region between the AR group and the control group.
H2: There is a difference in skill scores regarding the administration of intramuscular injections into the ventrogluteal region between the AR and control groups.
H3: There is a difference in state anxiety scores regarding the administration of intramuscular injections into the ventrogluteal region between the AR and control groups.
H4: There is a difference in satisfaction scores regarding training methods for intramuscular injection into the ventrogluteal region between the AR and the control group.
H5: There is a difference in knowledge scores regarding intramuscular injection into the ventrogluteal region between the 3D Model group and the control group.
H6: There is a difference in skill scores regarding intramuscular injection into the ventrogluteal region between the 3D Model group and the control group.
H7: There is a difference in state anxiety scores regarding intramuscular injection into the ventrogluteal region between the 3D Model group and the control group.
H8: There is a difference in satisfaction scores regarding training methods for intramuscular injection into the ventrogluteal region between the 3D Model group and the control group.
H9: There is a difference in retention scores regarding knowledge of intramuscular injection into the ventrogluteal region between the AR and control groups.
H10: There is a difference in retention scores regarding knowledge of intramuscular injection into the ventrogluteal region between the 3D Model and control groups.
H11: There is a difference in skill retention scores regarding the application of intramuscular injection into the ventrogluteal region between the AR and the control group.
H12: There is a difference in skill retention scores regarding the application of intramuscular injection into the ventrogluteal region between the 3D Model and the control group.
After providing theoretical training to the entire group, the researcher will randomly assign participants and have them practice using the AR, a 3D hip model, and a traditional model. After four weeks, the researcher will assess retention.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Meltem KAYA, PhD Candidate
- Phone Number: 0507-200-26-32
- Email: meltemkaya@karabuk.edu.tr
Study Contact Backup
- Name: Birgul CERIT, Professor
- Phone Number: 90-374 -253-45-20
- Email: birgulcerit@ibu.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be enrolled as a first-year student in the Department of Nursing at the Faculty of Health Sciences, Karabük University, during the spring semester of the 2025-2026 academic year.
- Have taken the "Fundamentals of Nursing" course for the first time.
- Have not previously received training in the skill of administering IM injections,
- Be able to speak and understand Turkish.
- Be willing to participate in the study.
Exclusion Criteria:
- Failing to complete the research data collection forms in full,
- Having previously taken the "Fundamentals of Nursing" course,
- Withdrawing from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Augmented Reality Group
The AR software was developed by a computer engineer using the Unity 3D program.
The researcher provided the developer with images of the ventrogluteal region and demonstrated the steps for performing an intramuscular injection into the ventrogluteal region via video.
The developed AR software was ported to the Meta Quest 3 headset, which supports both virtual reality and augmented reality.
With the Meta Quest 3 headset, students will be able to view virtual images in a real-world environment and perform the procedure using their hands.
|
Students in this group will perform intramuscular injections into the ventrogluteal region using a Meta Quest 3 headset via an augmented reality-based training application
|
|
Experimental: 3D Model Group
A 3D scanner and a Creality K2 Plus 3D printer located at the Iron and Steel Institute of Karabük University were used.
First, the hip model located in the Anatomy Laboratory of the Faculty of Medicine at Karabük University was scanned using the 3D scanner's Blue Laser mode.
Subsequently, the 3D model of the scanned hip was processed using 3D software on a computer to define dimensions, create the injection site, and determine the print slices, thereby designing the final pre-print configuration.
The model was printed in four parts using the Creality K2 Plus 3D Printer and assembled to create the final model.
The left side of the 3D hip model was designed to display anatomical structures for regional training, while the right side was designed to accommodate an injection port for IM injections into the VG region.
|
Students in this group will perform intramuscular injections into the ventrogluteal region using a 3D hip model.
The model will be used as visual and tactile learning tools during the training process.
|
|
No Intervention: Control group
In accordance with traditional educational methods, students will perform an intramuscular injection into the ventrogluteal region using the model in the laboratory, following the step-by-step procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ventrogluteal Region Intramuscular Injection Skill Checklist Score
Time Frame: Immediately after the intervention and 4 weeks after the intervention
|
Assessment of students' performance in administering intramuscular injections into the ventrogluteal region using a standardized skill assessment checklist.Assessment will be conducted by marking "applied" (2 points), "partially applied" (1 point), or "not applied" (0 points) for each step the student performs.
The total score obtainable from the Ventrogluteal Region Intramuscular Injection Skills Checklist ranges from 0 to 64.
|
Immediately after the intervention and 4 weeks after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ventrogluteal Region Intramuscular Injection Knowledge Test Score
Time Frame: Baseline (before theoretical training and randomization), immediately after the intervention, and 4 weeks after the intervention
|
Assessment of students' theoretical knowledge using a structured knowledge test.The knowledge test is a multiple-choice test consisting of 32 questions with five options each.
Each question on the knowledge test is worth 1 point.
The possible score on the test ranges from 0 to 32.Baseline measurement will be used to assess group comparability after randomization.
|
Baseline (before theoretical training and randomization), immediately after the intervention, and 4 weeks after the intervention
|
|
State Anxiety Scale score
Time Frame: Immediately after the theoretical training session and immediately after the intervention session
|
Measurement of students' anxiety levels using an anxiety assessment scale.The State Anxiety Scale consists of 20 items, and the possible scores range from 20 to 80. On the State Anxiety Scale, participants rate their responses on a four-point scale ranging from "Not at all" (1) to "Completely" (4).An increase in the score obtained from the scale indicates higher levels of anxiety, whereas a decrease indicates lower levels of anxiety.
|
Immediately after the theoretical training session and immediately after the intervention session
|
|
Satisfaction Survey Score for Teaching Methods
Time Frame: Immediately after the intervention
|
Evaluation of students' satisfaction with the educational method using a satisfaction questionnaire.The five-point Likert-type scale consists of 16 items.
The lowest possible score on the scale is 16, while the highest is 80.An increase in the score obtained from the scale indicates higher levels of satisfaction with the educational method, whereas a decrease in the score indicates lower levels of satisfaction.
|
Immediately after the intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ventrogluteal Region Intramuscular Injection Knowledge Test Score
Time Frame: 4 weeks after the intervention
|
Evaluation of the retention of knowledge 4 weeks after the intervention.The Ventrogluteal Region Intramuscular Injection Knowledge Test will be administered.The knowledge test is a multiple-choice instrument consisting of 32 items, each with five response options.
Each item is scored as 1 point.
The total score ranges from 0 to 32.
Higher scores indicate a higher level of students' knowledge regarding ventrogluteal intramuscular injection.
|
4 weeks after the intervention
|
|
Ventrogluteal Region Intramuscular Injection Skill Checklist Score
Time Frame: 4 weeks after the intervention
|
The Ventrogluteal Region Intramuscular Injection Skills Checklist will be used.The ventrogluteal intramuscular injection checklist consists of 32 steps.
Each step is evaluated as follows: performed (2 points), partially performed (1 point), or not performed (0 points).
The total possible score ranges from 0 to 64.
A higher total score indicates a higher level of students' skill in performing ventrogluteal intramuscular injection.
|
4 weeks after the intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Meltem KAYA, PhD Candidate, Karabuk University
- Study Chair: Birgul CERIT, Professor, Abant Izzet Baysal University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/2658 (Other Identifier: Karabük University Non-Interventional Clinical Research Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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