Online vs. In-Person Suturing Training: A Non-Inferiority Randomized Controlled Trial in a Low-Resource Setting

NCT ID: NCT07038525

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-13
• Study Completion Date: 2025-05-17

Brief Summary

The goal of this clinical trial is to assess whether online suturing training is non-inferior to in-person training in developing suturing skills among medical students at Yarmouk University in a low-resource setting.

The main questions it aims to answer are:

• Is online suturing training as effective as in-person training in developing practical skills (as measured by OSATS scores)?
• Does online training result in comparable knowledge improvement compared to in-person training (as measured by MCQ scores)?

Researchers will compare the online video-based training with Zoom feedback to live instructor-led in-person training to see if the online approach is not clinically inferior in terms of skills and knowledge acquisition.

Participants will:

• Complete pre-assessment and informed consent
• Be randomly assigned to one of the two training groups using stratified block randomization
• Participate in a suturing workshop either in-person or via online video and Zoom feedback
• Complete a post-assessment including OSATS-evaluated performance and MCQ test

Allocation concealment will be maintained, and the OSATS scores will be assessed by a blinded evaluator using a standardized checklist.

Detailed Description

This randomized controlled trial aims to evaluate the effectiveness of online versus in-person suturing training among medical students in a low-resource setting. Suturing is a core skill expected of medical students and a critical component of surgical training. With increasing demand for flexible and accessible medical education, online learning platforms have gained popularity. However, the comparative effectiveness of virtual training versus traditional in-person instruction in delivering procedural skills remains underexplored, particularly in low-resource environments.

This trial is designed as a phase II, parallel-group, non-inferiority randomized controlled trial with stratified block randomization and blinded outcome assessment. The goal is to determine whether online video-based suturing instruction, supplemented with real-time feedback via Zoom, is non-inferior to traditional in-person training in achieving technical skill acquisition, as measured by the Objective Structured Assessment of Technical Skills (OSATS).

Study participants are pre-clinical and clinical medical students from Yarmouk University who voluntarily consent to participate and complete all phases of the study. Participants will be stratified based on prior suturing experience (Yes/No) and randomly assigned in blocks of 4 or 6 to ensure balanced distribution across both training arms.

Allocation concealment is preserved through a standardized process: participants provide informed consent and complete baseline assessments before group assignment is revealed. The intervention is delivered in one of two formats, with both groups using identical suturing kits and standardized instructional material to reduce variability.

The in-person group receives live instructor-led training during a hands-on session.

The online group receives a pre-recorded instructional video and practices independently using the kit, followed by live Zoom-based feedback from a trainer.

Following the intervention, all participants are assessed via two primary methods:

• OSATS checklist, completed by a blinded evaluator based on video recordings of each participant's performance.
• Knowledge assessment, consisting of a five-question multiple choice test administered before and after the training to measure knowledge gain.

The OSATS tool used is a standardized and validated checklist evaluating multiple technical domains such as instrument handling, suture technique, and tissue approximation. The total OSATS score, which ranges based on the number of checklist items scored on a 1-5 scale, serves as the primary outcome. Knowledge scores (0-5) serve as the secondary outcome.

Statistical analysis will follow a pre-specified non-inferiority framework. Normality of score distributions will be assessed using Shapiro-Wilk tests. If assumptions are met, independent t-tests and 95% confidence intervals will be used to assess non-inferiority; if not, non-parametric alternatives (e.g., Mann-Whitney U tests) will be used. Sensitivity analyses will confirm robustness of findings using both parametric and non-parametric approaches. Within-group changes in knowledge scores will be analyzed using paired t-tests or Wilcoxon signed-rank tests, as appropriate.

To reduce potential bias, evaluator blinding is strictly maintained and only one evaluator is used to eliminate inter-rater variability. The use of standardized materials, identical kits, and consistent checklists across both groups ensures fairness and fidelity to protocol.

This study will serve as a pilot non-inferiority trial, intended to generate effect size estimates and assess the feasibility of larger-scale implementation in similar low-resource environments. While the planned sample size of 48 participants (24 per arm) may not detect moderate effect sizes with high power, it is sufficient to detect large differences and inform the design of future trials.

The broader educational aim of this trial is to provide insight into how surgical education can be adapted to virtual or remote learning formats without compromising quality, especially in regions where traditional instruction is limited by geographic, financial, or institutional constraints. Results may inform both local and international medical education strategies and support the development of cost-effective, scalable solutions to procedural training.

This project is conducted under the Live Your Dream (LYD) educational initiative and is fully self-funded by the investigator. No external funding or institutional sponsorship has been obtained. Results will be disseminated through academic conferences and peer-reviewed publication.

Conditions

Suture Techniques; Training Effectiveness; Online Education; Student Education; Hands-on Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

In person suturing training

Participants in this arm will attend a live, instructor-led suturing training session using standardized kits. The session will involve hands-on practice under direct supervision. The curriculum and assessment criteria are consistent with the online arm to ensure parity in instructional content.

Group Type: EXPERIMENTAL

Suturing training

Intervention Type: OTHER

This intervention involves basic suturing skills training delivered either in-person or online. In the in-person group, participants receive live instruction and hands-on supervision. In the online group, participants watch a standardized video tutorial and receive remote feedback via Zoom. All participants use identical suturing kits and are evaluated using the same OSATS checklist by a blinded assessor. The content and learning objectives are standardized across both formats.

Online suturing training

Participants in this arm will receive access to a pre-recorded instructional video and practice independently using identical kits. After completing the training, participants will receive real-time feedback via Zoom from a trainer. Instructional content and assessment tools are standardized across both groups.

Group Type: EXPERIMENTAL

Suturing training

Intervention Type: OTHER

This intervention involves basic suturing skills training delivered either in-person or online. In the in-person group, participants receive live instruction and hands-on supervision. In the online group, participants watch a standardized video tutorial and receive remote feedback via Zoom. All participants use identical suturing kits and are evaluated using the same OSATS checklist by a blinded assessor. The content and learning objectives are standardized across both formats.

Interventions

Suturing training

This intervention involves basic suturing skills training delivered either in-person or online. In the in-person group, participants receive live instruction and hands-on supervision. In the online group, participants watch a standardized video tutorial and receive remote feedback via Zoom. All participants use identical suturing kits and are evaluated using the same OSATS checklist by a blinded assessor. The content and learning objectives are standardized across both formats.

Intervention Type: OTHER

Other Intervention Names

Suturing skills workshop

Eligibility Criteria

Inclusion Criteria

• Medical students (Yarmouk university)
• Signed informed consent

Exclusion Criteria

• Incomplete workshop attendance
• Technical issues that hinder full participation

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Diala Burjak

OTHER

Sponsor Role: lead

Responsible Party

Diala Burjak

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Diala Burjak, MD

Role: PRINCIPAL_INVESTIGATOR

NYC Health + Hospitals/ Elmhurst Hospital

Locations

Jordan Medical Association

Irbid, , Jordan

Countries

Jordan

Other Identifiers

LYD-RCT001

Identifier Type: -

Identifier Source: org_study_id