NCT06494462

Brief Summary

This randomized controlled experimental study aimed to determine the effect of gamification-based virtual reality applications and video demonstration methods on nursing students' skill learning and confidence levels in subcutaneous injection skill training. The population of the study consisted of 96 first-year nursing students enrolled in the Fundamentals of Nursing course at a university's Faculty of Nursing during the spring semester of the 2024-2025 academic year. The students will be randomized into three groups, each containing 32 students: two experimental groups and one control group. First, the topic of subcutaneous injection application will be theoretically explained to all students for 90 minutes. After completing the theoretical explanation, the skill of subcutaneous injection application will be taught in a laboratory setting using the Gamification-Based Virtual Reality Application + Demonstration method for students in Experimental Group 1, the Video Demonstration + Demonstration method for students in Experimental Group 2, and only the Demonstration method for students in the Control Group. After the theoretical explanation and laboratory practices according to their groups, the subcutaneous injection skill levels of the students in all three groups will first be assessed in the laboratory setting using the Objective Structured Clinical Examination (OSCE) and later evaluated in the clinical setting using the Subcutaneous Injection Skill Checklist. The confidence levels of the students will be determined through self-reporting using the "Confidence Scale" after all clinical practices are completed. The research data will be collected between April and June 2025. Descriptive (number, percentage, mean, standard deviation, minimum-maximum) and comparative statistics (Chi-Square Test, Mann Whitney U Test, Wilcoxon Test) will be used in the analysis of the data. The level of statistically significance will be considered at p\<0.05.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

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

January 7, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

October 1, 2025

Status Verified

October 1, 2024

Enrollment Period

1.4 years

First QC Date

June 20, 2024

Last Update Submit

September 30, 2025

Conditions

Keywords

virtual realitygamesubcutaneous injectionskillnursing studentsconfidence

Outcome Measures

Primary Outcomes (1)

  • Skill Evaluation

    First, the evaluation will be conducted using the Objective Structured Clinical Examination (OSCE).The OSCE score will be determined according to the procedure steps specified in the SC Injection Skill Checklist. The form consisting of 27 items in which each application step is scored shows the skill level as points. In the evaluation, each step that the student performs correctly will be calculated as 2 points, each incomplete step will be calculated as 1 point, and each step that the student does not perform or performs incorrectly will be calculated as 0 points. The lowest score that can be obtained from the form is 0 and the highest score is 54. In the second stage, all students will be evaluated in Clinics of the University Hospital. Skill assessments will be performed using the Subcutaneous Injection Skill Checklist.The average score obtained as a result of the two assessments will determine the student's skill level.

    twice, first evaluation will take place up to 10 weeks after the begining of the study (end of laboratory training) and second evaluation will take place up to 12 weeks the begining of the study (after 7 or 15 days the laboratory training) in hospital

Secondary Outcomes (1)

  • Confidence

    once, up to 20 weeks (when the research is finished)

Study Arms (3)

game based virtual reality

EXPERIMENTAL

24 hours after the theoretical lecture, students will be given a demonstrative presentation of the application in the laboratory environment by the instructor (researcher). All students will perform the application on low-fidelity models (task trainers) under the supervision of the instructor. After the laboratory application, students will be required to play a gamified virtual reality experience using Oculus 2 Interactive Virtual Reality Headsets within 7 days before the clinical application.

Other: virtual reality training

Video

EXPERIMENTAL

24 hours after the theoretical lecture, students will be given a demonstrative presentation of the application in the laboratory environment by the instructor (researcher). All students will perform the application on low-fidelity models (task trainers) under the supervision of the instructor. After the laboratory application, students will be shown a video recording prepared by the researchers via VR Box non-interactive virtual reality headsets within 7 days before the clinical application.

Other: virtual reality training

Control

NO INTERVENTION

24 hours after the theoretical lecture, students will be given a demonstrative presentation of the application in the laboratory environment by the instructor (researcher). All students will perform the application on low-fidelity models (task trainers) under the supervision of the instructor.

Interventions

students will watch a video about subcutaneous injection or students will play a about subcutaneous injection by virtual reality glasses

Videogame based virtual reality

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • To be between 18-50 years old
  • To be a student of nursing department
  • Being a 1st year nursing student
  • To volunteer to participate in the research
  • Having internet access

You may not qualify if:

  • Being a graduate of a of health vocational high school
  • Having received training on SC injection,
  • Have a clinical experience,
  • To be absent from the theoretical and laboratory courses on the dates of SC injection subject

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adnan Menderes University Nursing Faculty

Aydin, Turkey (Türkiye)

Location

Study Officials

  • Barış Atiker

    Aydin Adnan Menderes University

    PRINCIPAL INVESTIGATOR

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
Principal Investigator

Study Record Dates

First Submitted

June 20, 2024

First Posted

July 10, 2024

Study Start

January 7, 2024

Primary Completion

June 2, 2025

Study Completion

September 1, 2025

Last Updated

October 1, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

The data that support the findings of this study are available onrequest from the corresponding author.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
end of the study
Access Criteria
The data that support the findings of this study are available onrequest from the corresponding author.

Locations