- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06506851
Effects of Augmented Reality-based Rapid Blood Transfusion (Level-1®)
Effects of Augmented Reality-based Rapid Blood Transfusion (Level-1®) Education on Nurse's Clinical Competency, Self-efficacy, and Educational Satisfaction: Randomised Controlled Trial
The goal of this clinical trial is to compare the effectiveness of AR-based training with traditional guideline-based self-learning in practical nurses without prior Level-1® experience. The main questions it aims to answer are:
Does AR-based training using Microsoft HoloLens 2® improve clinical performance compared to traditional guideline-based self-learning? Does AR-based training affect self-efficacy and educational satisfaction compared to traditional methods?
Participants will:
Receive AR-based training using Microsoft HoloLens 2® (experimental group) Follow traditional guideline-based self-learning (control group) Researchers will compare the AR-based training group to the traditional self-learning group to see if AR-based training leads to better clinical performance, higher self-efficacy, and greater educational satisfaction.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In critical situations like hypovolemic shock, nurses must master skills for using devices like the Level-1® rapid infusion system. However, limited exposure poses challenges. Augmented reality (AR) offers a solution by providing realistic practice scenarios. While AR has shown effectiveness in cardiopulmonary resuscitation and intubation education, its application in Level-1® training remains underexplored.
This study was conducted at the Samsung Medical Center in Seoul, Korea, and involved 42 practical nurses without prior Level-1® experience. Participants were randomly assigned to one of two groups: the experimental group, which received AR-based training using Microsoft HoloLens 2®, and the control group, which followed traditional guideline-based self-learning.
The study aimed to investigate the impact of AR-based Level-1® education on nurses' clinical performance, self-efficacy, and educational satisfaction. Clinical performance, self-efficacy, and educational satisfaction were assessed through structured measurements.
Results data and conclusions drawn from the data are excluded from this section and will be reported separately in the Results Section of the record.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of, 06351
- Samsung Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Willingness to participate voluntarily and understanding of the study's purpose.
- No prior experience with the Level-1® rapid infusion system.
Exclusion Criteria:
- Failure to meet the inclusion criteria.
- Prior experience with the Level-1® rapid infusion system.
- Inability to comprehend the study's purpose or express voluntary participation.
- Inability to attend required training and evaluations.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AR-based Training Group
Practical nurses in this arm receive AR-based training using Microsoft HoloLens 2®.
This training method incorporates augmented reality technology to provide immersive and interactive learning experiences, enhancing their proficiency in device utilization.
|
Practical nurses in this group receive AR-based training using Microsoft HoloLens 2®.
This training method incorporates augmented reality technology to provide immersive and interactive learning experiences, enhancing their proficiency in device utilization.
|
|
Sham Comparator: Traditional Self-Learning Group
Practical nurses in this arm follow traditional guideline-based self-learning methods without augmented reality technology.
They rely on conventional educational materials and guidelines for learning device utilization skills.
|
Practical nurses in this group follow traditional guideline-based self-learning methods without augmented reality technology.
They rely on conventional educational materials and guidelines for learning device utilization skills.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Competency
Time Frame: before training, immediately after training
|
This measurement assesses nurses' clinical competency in rapid infusion procedures.
It includes evaluation of learning time, performance time, accuracy, and assistance requests.
|
before training, immediately after training
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-efficacy
Time Frame: efore training, immediately after training
|
This assessment measures nurses' self-efficacy in rapid infusion procedures using a modified self-efficacy scale.
It evaluates confidence levels in performing tasks related to rapid infusion.
|
efore training, immediately after training
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Educational Satisfaction Evaluation
Time Frame: Educational satisfaction will be assessed immediately after the completion of the training program.
|
This evaluation assesses nurses' satisfaction with the educational program.
It includes measures of confidence, relevance, and willingness to recommend the training to others using a structured questionnaire.
|
Educational satisfaction will be assessed immediately after the completion of the training program.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: meonghi son, MD, Samsung Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Other Study ID Numbers
- 2023-06-084
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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