Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06359158 |
Other study ID # |
eStethoscope for Med Student |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 1, 2023 |
Est. completion date |
January 31, 2024 |
Study information
Verified date |
April 2024 |
Source |
Chung Shan Medical University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Objectives: This study aims to assess the effectiveness of a novel digital stethoscope
curriculum integrated into respiratory auscultation training for medical students. It seeks
to compare the auscultation proficiency gained through this innovative approach with that
from traditional teaching methods, to understand the potential of digital stethoscopes in
reinvigorating clinical skills training.
Methods: In a single-center, controlled, longitudinal, randomized experimental design, 84
medical students undergoing clinical clerkship rotations at Chung Shan Medical University
Hospital were enrolled. Participants were randomly assigned to either the intervention group,
receiving training with digital stethoscopes and the Eko auscultation software, or the
control group, following a traditional curriculum. Pre- and post-intervention assessments
measured auscultation skills, and student feedback on teaching quality was collected. The
primary outcome was the improvement in auscultation proficiency, while secondary outcomes
included student engagement and feedback on the educational approach.
Expected Results: The investigators hypothesize that the integration of digital stethoscopes
into the curriculum will significantly improve the auscultation skills of medical students
compared to traditional methods. Enhanced engagement and positive feedback from students are
anticipated, underscoring the pedagogical value of incorporating digital health technologies
in medical education.
Description:
Subjects and Procedures Research Methodology The present investigation carried out at a
university hospital, was a longitudinal, controlled, single-center, randomized trial with an
interventional design. A total of 84 medical students who were completing their clinical
clerkship rotations in the Department of Thoracic Surgery were included in the study. The
participants were randomized to either the intervention group or the control group.
Intervention The participants in the intervention group were provided with the curriculum
titled "Respiratory Auscultation with Digital Stethoscopes," which involved the use of
electronic digital stethoscopes and the Eko auscultation software platform developed by Eko
Devices in Berkeley, California, USA. The utilization of this methodology enabled the viewing
and examination of documented respiratory sounds, which were then shown as phonopneumograms.
The participants assigned to the control group were provided with conventional respiratory
auscultation training in accordance with the established clerkship curriculum. The curriculum
encompassed practical sessions conducted at the Objective Structured Clinical Examination
(OSCE) center, utilizing the SAM II respiratory sound simulator (Cardionics, Webster, Texas,
USA). Additionally, instructional videos were provided to facilitate the acquisition of
knowledge pertaining to breath sounds. Furthermore, a breathing assignment was assigned to
each student, necessitating the recording and description of five distinct breath sounds. The
process of gathering data The Zuvio Interactive Response System (Zuvio, Taipei, Taiwan) was
used to measure participants' auscultation skills before and after the intervention. This was
done by employing a question bank consisting of 50 breath sound audio files. The collection
of student feedback regarding the quality of teaching and the helpfulness of the course was
conducted by means of surveys employing 5-point Likert scales. Furthermore, the researchers
collected data pertaining to OSCE attendance, video viewing, answer-checking behavior, and
the time interval between pre-and post-tests. The variables that were assessed included
alterations in auscultation test scores and self-reported levels of teaching satisfaction
within the two cohorts.
Statistical analysis The data analysis was performed utilizing the Statistical Package for
Social Sciences (IBM SPSS Statistics, version 25). A range of statistical tests were employed
to comprehensively analyze the distribution of student scores and teaching satisfaction,
compare the intervention and control groups, and explore the influence of the course on
students' engagement and learning outcomes. The normality of distributions for student scores
and teaching satisfaction was initially examined using the Kolmogorov-Smirnov test. To
compare scores and satisfaction levels between the intervention and control groups, either
the Student t-test or the Mann-Whitney U test was selected, depending on the distributions.
The paired Student's t-test or the Wilcoxon signed-rank test was used, as appropriate, to
assess the changes in scores before and after the course. The study employed the chi-square
test to examine the disparity in the proportions of students from both groups who opted to
rent electronic stethoscopes subsequent to the completed course. This was conducted as an
indirect method to assess the student's level of interest in auscultation and their
comprehension of digital stethoscope technology, hence indicating the effectiveness of the
course instruction. In addition, the researchers used regression analysis to investigate the
relationships between different variables and outcomes, thereby offering valuable insights
into the determinants that impact students' learning experiences and preferences. The
statistical significance level was set at p<0.05.