- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06171828
Tele-education in Ultrasound Training
Feasibility of Tele-education in Ultrasound Training: a Randomized, Controlled Pilot Study
Study Overview
Status
Intervention / Treatment
Detailed Description
The study's design includes pre-surveys, random assignment, ultrasound training through educational videos, and distinct practice methods for each group - one with remote guidance and the other with traditional, in-person assistance. The effectiveness of training will be evaluated based on scores from evaluation forms, time taken for ultrasound imaging, frequency of requesting help, and surveys (NASA-Task Load Index, System Usability Scale, and a Self-confidence pre/post survey). Statistical analysis will be conducted using R software, employing tests such as the student t-test or Wilcoxon rank sum test.
This research is anticipated to provide valuable insights into the efficacy of remote guidance in ultrasound education, potentially influencing future medical training methodologies.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of, 06351
- Samsung Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Licensed doctor
- Participants who didn't receive prior training in abdominal ultrasound
- > 18 years old
Exclusion Criteria:
- Individuals who do not agree to participate in 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 |
|---|---|
|
No Intervention: Control Group (Traditional Training)
This arm of the study involves participants who will engage in a traditional learning process.
After an initial pre-survey, they will start the ultrasound training phase.
During this phase, participants will utilize pre-made educational videos for learning.
Then participants will perform an ultrasound on an abdominal ultrasound phantom using a handout based on the pre-made video.
When assistance is needed, participants will physically move to a different location to seek help from a supervisor.
This face-to-face interaction allows for direct guidance and feedback.
After completing the training sessions, participants will take a post-survey, which includes NASA-TLX, System Usability Scale (SUS), and a self-confidence assessment, to evaluate the training experience and measure the perceived workload, system usability, and confidence level changes due to the training.
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Experimental: Experimental Group (Remote Training)
In this arm, participants will undergo a remote learning process.
Similar to the control group, they begin with a pre-survey followed by the training phase using the same educational videos.
Participants view a handout on a head-mounted display(HMD) and perform an ultrasound on an abdominal ultrasound phantom.
The key difference is that when they require assistance, they will use a HMD to communicate with a supervisor remotely.
This allows the supervisor to provide guidance without being physically present, utilizing the HMD and potentially other remote communication tools for real-time interaction.
The training phase is intended to mimic the in-person guidance as closely as possible through technological means.
Following the training, the participants will also complete the same post-survey as the control group to assess the impact of remote training on their learning experience.
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Participants in the experimental group are oriented on using the education platform and communicating with the supervisor through an HMD for about 5 minutes.
They then perform and save their ultrasound imaging.
If they require assistance, they request help verbally through the HMD's communication system.
The supervisor remotely observes and immediately assists upon request, utilizing the HMD and a 360-degree camera.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Ultrasound Skill Evaluation Scale
Time Frame: During the education session, approximately 30 minutes
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The composite scores from the evaluation forms will serve as the primary measure of effectiveness.
These scores will be based on a standardized evaluation scale titled "Ultrasound Skill Evaluation Scale", which ranges from 0 to 90 points, where higher scores indicate better performance.
Scores will be analyzed and compared using statistical tests such as the Student's t-test or the Wilcoxon rank-sum test to evaluate skill acquisition differences between groups.
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During the education session, approximately 30 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ultrasound Imaging Duration
Time Frame: During the education session, approximately 30 minutes
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The time taken by participants from the moment they pick up the probe to begin the first image until they press the 'End Exam' button to save the final ultrasound image will be recorded and analyzed.
This measure assesses efficiency and speed of learning, with comparison between groups using the Student's t-test or Wilcoxon rank-sum test.
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During the education session, approximately 30 minutes
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Number of Assistance Requests
Time Frame: During the education session, approximately 30 minutes
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The frequency with which participants request help from the supervisor will also be tracked.
This measure will help to understand the level of independence and confidence during the ultrasound procedure, as well as to determine if the time taken for the task is affected by these requests.
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During the education session, approximately 30 minutes
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NASA-Task Load Index (TLX)
Time Frame: After the training (Traditional and HMD), approximately 1hr
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The NASA Task Load Index (NASA-TLX) survey will be used to compare the perceived workload between participants seeking physical assistance and those receiving remote guidance through head-mounted displays (HMDs).
Six aspects of workload will be assessed: mental demand, physical demand, temporal demand, performance, effort, and frustration.
Scores range from 0 (lowest workload) to 100 (highest workload).
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After the training (Traditional and HMD), approximately 1hr
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System Usability Scale (SUS)
Time Frame: After the training (Traditional and HMD), approximately 1hr
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Participants will complete the System Usability Scale (SUS) survey based on their experience with the abdominal ultrasound training.
The SUS score measures system usability on a scale ranging from 0 to 100, with higher scores indicating better usability.
The scores will be calculated according to the standard scoring system.
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After the training (Traditional and HMD), approximately 1hr
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Confidence Assessment
Time Frame: After the training (Traditional and HMD), approximately 1hr
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Pre- and post-training surveys will assess participants' confidence in identifying abdominal organs using ultrasound.
Confidence will be rated on a Likert scale from 1 (not confident at all) to 5 (extremely confident).
Changes in self-perceived competence before and after training will be analyzed.
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After the training (Traditional and HMD), approximately 1hr
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: 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
Other Study ID Numbers
- 2023-10-015-003
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
product manufactured in and exported from the U.S.
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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