Tele-education in Ultrasound Training

January 1, 2025 updated by: Samsung Medical Center

Feasibility of Tele-education in Ultrasound Training: a Randomized, Controlled Pilot Study

The study aims to assess the impact of remote guidance in ultrasound training for medical professionals new to abdominal ultrasound. It involves 40 participants, divided into two groups of 20 each - a self-study group and a remote learning group. Participants include licensed doctors with no prior training in abdominal ultrasound, who are over 18 years old and have consented to participate.

Study Overview

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

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound Skill Evaluation Scale
Time Frame: During the education session, approximately 30 minutes
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.
During the education session, approximately 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasound Imaging Duration
Time Frame: During the education session, approximately 30 minutes
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.
During the education session, approximately 30 minutes
Number of Assistance Requests
Time Frame: During the education session, approximately 30 minutes
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.
During the education session, approximately 30 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
NASA-Task Load Index (TLX)
Time Frame: After the training (Traditional and HMD), approximately 1hr
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).
After the training (Traditional and HMD), approximately 1hr
System Usability Scale (SUS)
Time Frame: After the training (Traditional and HMD), approximately 1hr
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.
After the training (Traditional and HMD), approximately 1hr
Confidence Assessment
Time Frame: After the training (Traditional and HMD), approximately 1hr
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.
After the training (Traditional and HMD), approximately 1hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Meonghi Son, MD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Actual)

December 14, 2023

Study Completion (Actual)

December 14, 2023

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Actual)

December 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 1, 2025

Last Verified

November 1, 2023

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)?

UNDECIDED

IPD Plan Description

Not yet decided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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