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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06171828
Other study ID # 2023-10-015-003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 15, 2023
Est. completion date December 14, 2023

Study information

Verified date November 2023
Source Samsung Medical Center
Contact minha kim, MD
Phone 010-4723-2324
Email dokidoki90@naver.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 14, 2023
Est. primary completion date December 14, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Device:
Head-Mounted Display (HMD) to communicate with a supervisor remotely
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.

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other NASA-Task Load Index (TLX) A series of surveys will be used to assess the participant's experience and the educational impact of the training methods.
NASA-TLX will compare the workload between physical movement to seek help and receiving remote guidance while wearing the HMD. It will evaluate six aspects of workload: mental, physical, temporal, performance, effort, and frustration levels.
after the training (Traditional and HMD), an average of 1hr
Other System Usability Scale (SUS) Right after the training, participants will complete the SUS based on their experience with the abdominal ultrasound training. The SUS score provides a quick measure of the system's usability and will be calculated according to the standard scoring system. After the training (Traditional and HMD), an average of 1hr
Other Confidence Assessment A pre- and post-training survey will be conducted to evaluate changes in the participants' confidence in identifying specific abdominal organs via ultrasound. This will assess the educational effect of the training on the participants' self-perceived competence. Pre and post training (Traditional and HMD), an average of 1hr
Primary Evaluation Scores The composite scores from the evaluation forms will be the primary measure of effectiveness. These scores will be analyzed and compared using statistical tests such as the student t-test or the Wilcoxon rank sum test to determine the level of ultrasound skill acquisition between the two groups. During the education,an average of 30min
Secondary Ultrasound Imaging Duration 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 t-test or Wilcoxon rank sum test. During the education,an average of 30min
Secondary Number of Assistance Requests 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, an average of 30min
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