NCT06221917

Brief Summary

The goal of this observational study is to assess objectively whether teaching for simple wound sutures via Live-Streaming (LS) using Go-pro® has the same effectiveness as the traditional Face-to-face (FTF) teaching. The main question it aims to answer is whether training simple wound suturing skills to surgical clerkships via LS has the same effectiveness as the FTF training. After initially doing pre-test, participants will be randomized into two groups: LS and FTF. After teaching exposure, the participants will be given 1 week period of self-training to master the skill (as such procedural skills require a period of self training before we examine the effect of teaching exposure). Afterwards, they underwent post-test again with the previously same examiner, using the same OSCE rubric to avoid bias. Researchers will compare if the LS and FTF groups to see if training simple wound suturing skills to surgical clerkships via LS has the same effectiveness as the FTF training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

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 9, 2024

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2024

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

3 months

First QC Date

January 15, 2024

Last Update Submit

November 6, 2024

Conditions

Keywords

Teaching methodLive-streamingFace-to-faceSimple wound suturing

Outcome Measures

Primary Outcomes (1)

  • Post-test Scores

    Post-test Objective Structured Clinical Exam (OSCE) scores Value ranges from 0 to 60. Higher score means better outcome, and vice versa.

    1 week after teaching

Secondary Outcomes (1)

  • Numerical Differences of Pre-test and Post-test (Delta)

    1 week after teaching

Study Arms (2)

Face-to-face

ACTIVE COMPARATOR

Face-to-face teaching method

Other: Face-to-face

Live-streaming

EXPERIMENTAL

Live-streaming teaching method

Other: Live-streaming

Interventions

FTF group are participants who will learn simple sutures physically present with the instructor in the same room.

Face-to-face

One general surgeon (FH) will teach the participants how to do simple sutures on a mannequin, starting by explaining, then doing a live-demo step-by-step of simple wound suturing. The instructor uses a GoPro Hero 8 device on her head which is connected to the internet and produced live-streaming video, which will then be watched by LS group.

Live-streaming

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Surgery clerkships
  • Willing to participate voluntarily and give consent to the study

You may not qualify if:

  • Participants who drop out between 1 week period of pre-test and post-test
  • Participants not willing to be involved in the teaching exposure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pelita Harapan University

Tangerang, Banten, 15811, Indonesia

Location

Related Publications (5)

  • Foo CC, Cheung B, Chu KM. A comparative study regarding distance learning and the conventional face-to-face approach conducted problem-based learning tutorial during the COVID-19 pandemic. BMC Med Educ. 2021 Mar 3;21(1):141. doi: 10.1186/s12909-021-02575-1.

    PMID: 33658015BACKGROUND
  • McKechnie T, Levin M, Zhou K, Freedman B, Palter VN, Grantcharov TP. Virtual Surgical Training During COVID-19: Operating Room Simulation Platforms Accessible From Home. Ann Surg. 2020 Aug;272(2):e153-e154. doi: 10.1097/SLA.0000000000003999. No abstract available.

    PMID: 32675522BACKGROUND
  • Doulias T, Gallo G, Rubio-Perez I, Breukink SO, Hahnloser D. Doing More with Less: Surgical Training in the COVID-19 Era. J Invest Surg. 2022 Jan;35(1):171-179. doi: 10.1080/08941939.2020.1824250. Epub 2020 Sep 22.

    PMID: 32959688BACKGROUND
  • Navia A, Parada L, Urbina G, Vidal C, Morovic CG. Optimizing intraoral surgery video recording for residents' training during the COVID-19 pandemic: Comparison of 3 point of views using a GoPro. J Plast Reconstr Aesthet Surg. 2021 May;74(5):1101-1160. doi: 10.1016/j.bjps.2020.10.068. Epub 2020 Nov 8. No abstract available.

    PMID: 33199220BACKGROUND
  • Song JSA, McGuire C, Vaculik M, Morzycki A, Plourde M. Cross sectional analysis of student-led surgical societies in fostering medical student interest in Canada. BMC Med Educ. 2019 Mar 8;19(1):77. doi: 10.1186/s12909-019-1502-5.

    PMID: 30849966BACKGROUND

Study Officials

  • Freda Halim, Dr, dr, SpB

    Pelita Harapan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Surgery Department, Principal Investigator

Study Record Dates

First Submitted

January 15, 2024

First Posted

January 24, 2024

Study Start

January 9, 2024

Primary Completion

April 9, 2024

Study Completion

April 10, 2024

Last Updated

November 8, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) will be made publicly available as part of an open access dataset.

Time Frame
The data will be available shortly after the study is finished, and will be available publicly for as long as needed.
Access Criteria
Open
More information

Locations