- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT05275829
Face-to-Face Versus Distance Learning of Basic Suturing Skills
Traditional Face-to-Face Versus Distance Learning of Basic Suturing Skills in Novice Learners
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
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
-
Beirut, Libanon, 1104
- American University of Beirut Medical Center
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Control group: Face-to-Face learning of simple interrupted suturing
|
|
|
Study group: Distance learning (tele simulation) of simple interrupted suturing
|
Interactive tele simulation sessions utilising web-based video-conferencing technology (WebEx platform).
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Assessment of suturing skills in medical students via checklist
Tijdsspanne: immediately after the intervention(suturing session)
|
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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Assessment of suturing skills in medical students via OSATS
Tijdsspanne: immediately after the intervention(suturing session)
|
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)
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Questionnaire that assesses confidence and satisfaction
Tijdsspanne: immediately after the intervention( suturing session)
|
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)
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Ahmad Zaghal, MD, MSc, FACS, FEBPS, American University of Beirut Medical Center ; Department of Surgery
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- SBS-2020-0378
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .