NCT05275829

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
Last Updated

March 11, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

February 24, 2022

Last Update Submit

March 4, 2022

Conditions

Keywords

Medical EducationSuturing SkillsFace-to-Face learningDistance LearningPandemic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Assessment of suturing skills in medical students via OSATS

    immediately after the intervention(suturing session)

Other Outcomes (1)

  • Questionnaire that assesses confidence and satisfaction

    immediately after the intervention( suturing session)

Study Arms (2)

Control group: Face-to-Face learning of simple interrupted suturing

* The students watched a video demonstrating simple interrupted suturing, with the instructor commenting on the steps. * The students then watched the video again. * The instructor then demonstrated the procedure for the students. * The students then practiced suturing with immediate and specific feedback provided by the instructor until he and the students were satisfied with the performance.

Study group: Distance learning (tele simulation) of simple interrupted suturing

* The instructor ran the interactive tele simulation sessions utilising web-based video-conferencing technology (WebEx platform). The students used their personal smartphones or laptops with audio-video capabilities. The instructor ran the session through his smartphone. * The instructor shared a video demonstrating simple interrupted suturing while commenting on the steps (the same video used in the control group). * The instructor then ran the video again for the students. * The instructor then demonstrated the skill for the students by turning on his camera. * The students then practiced suturing, and periodically turned on their cameras to receive live and specific feedback from the instructor on their performance, until the instructor and the students were satisfied. * No face-to-face interactions between the students and the instructor.

Other: Tele simulation

Interventions

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

Study group: Distance learning (tele simulation) of simple interrupted suturing

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pre-medical, first, and second-year medical students from a four-year Doctor of Medicine graduate-entry programme. Premedical students include senior biology, medical laboratory, and nutrition students. All participants had no previous experience with suturing. Basic suturing is one of the educational activities of the third-year medical students, before which students are not normally exposed to basic suturing skills teaching sessions. The participants were recruited via an email sent to all the potential candidates for participation in this study.

You may qualify if:

  • Pre-medical, first, and second-year medical students with no previous experience in suturing.

You may not qualify if:

  • Previous experience in suturing.Refusal of enrolment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

American University of Beirut Medical Center

Beirut, 1104, Lebanon

Location

Study Officials

  • Ahmad Zaghal, MD, MSc, FACS, FEBPS

    American University of Beirut Medical Center ; Department of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Speciality

Study Record Dates

First Submitted

February 24, 2022

First Posted

March 11, 2022

Study Start

January 4, 2021

Primary Completion

May 19, 2021

Study Completion

May 19, 2021

Last Updated

March 11, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

The datasets generated and/or analysed during the current study are not publicly available due to the Institutional Review Board requirements but are available from the corresponding author upon a reasonable request.

Locations