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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05275829
Other study ID # SBS-2020-0378
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 4, 2021
Est. completion date May 19, 2021

Study information

Verified date March 2022
Source American University of Beirut Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main objective of this study is to determine the acceptability and effectiveness of Distance Learning (DL) of basic suturing skills in novice learners. A prospective randomized controlled trial involving 118 pre-medical and medical students with no previous experience in suturing was conducted. Participants were randomized into two groups for learning simple interrupted suturing: F-F and DL groups (59 students in each group) . Evaluation was conducted by two independent assessors. Agreement between the assessors was calculated, and performance scores of the participants were compared between the two groups. All the participants demonstrated their ability to place three interrupted sutures, with no significant difference in the performance between the two groups. All the respondents positively rated the teaching sessions, found them useful and enjoyable. Distance learning of basic suturing is as effective as the face-to-face approach in novice learners


Description:

At our hospital, during the initial lock-down period in March and April 2020, all medical students' clinical clerkships were temporarily cancelled, and their educational activities switched to web-based remote learning, utilizing teleconferencing and commercially available web-based interactive clinical modules. Teaching surgical technical skills, such as basic suturing, presented itself as a more challenging component of the clinical education under these unusual circumstances as compared to teaching cognitive skills and knowledge, which raised questions and concerns around the effectiveness and acceptability of distance learning of basic surgical skills. In this study, the investigators aimed to compare the effectiveness and retention of distance learning to the traditional face-to-face learning of basic (simple interrupted) suturing in novice learners. This study entails a prospective randomized trial involving two arms (traditional face-to-face versus distance learning of basic simple interrupted suturing) in pre-medical students as well as first and second year medical students at the American University of Beirut (AUB). Immediately after the teaching session as part of research, two independent surgeons assessed the students' simple interrupted suturing performance using a validated checklist and OSATS global rating. The difference in performance was used to determine the effectiveness of distance learning of basic suturing as compared to the traditional instructional method. In addition, the students in both groups were asked to complete a questionnaire (immediately after the teaching session) to investigate their satisfaction and confidence.


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date May 19, 2021
Est. primary completion date May 19, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria: - Pre-medical, first, and second-year medical students with no previous experience in suturing. Exclusion Criteria: - Previous experience in suturing.Refusal of enrolment.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Tele simulation
Interactive tele simulation sessions utilising web-based video-conferencing technology (WebEx platform).

Locations

Country Name City State
Lebanon American University of Beirut Medical Center Beirut

Sponsors (1)

Lead Sponsor Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

Outcome

Type Measure Description Time frame Safety issue
Other Questionnaire that assesses confidence and satisfaction The students were asked, on voluntary basis, to electronically fill a brief anonymous questionnaire after the completion of their respective sessions to evaluate their satisfaction (acceptability), confidence levels, and attitudes towards the instructional method they experienced (Figure 4). We followed the AMEE's guide No.87 (Artino et-al, 2014) recommendations for the survey items development, making sure to use clear self-explanatory language, avoid using negative-worded sentences, and include verbal labels for all the Likert-scale responses of the closed-ended items. We have also included three open-ended questions to gain a more detailed grasp of the students' perceptions of their learning experience. immediately after the intervention( suturing session)
Primary Assessment of suturing skills in medical students via checklist The adopted ten-item checklist for assessing suturing skills in medical studentS differentiated between novice and expert performances and showed a narrow variation in the scores provided by three independent expert assessors.
Overall performance scores were calculated based on the formula used by the same authors: "cutoff time (seconds) - completion time (seconds) - (10 x sum of errors)" with higher scores indicating better performance
immediately after the intervention(suturing session)
Secondary Assessment of suturing skills in medical students via OSATS OSATS is a validated observational assessment tool also used in medical students. It comprises of seven performance domains whereby learners are scored on a 5-point Likert scale on proper tissue handling, efficiency and economy of movements, instrument handling, suture handling, flow of the procedure, knowledge of the steps of the procedure, overall appearance of the suture, in addition to an overall assessment of the performance; higher scores indicate better performance immediately after the intervention(suturing session)
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