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

NCT07038525 | Completed

• 1 other identifier: LYD-RCT001
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

suturing skills; surgical education; online medical training; hands-on workshop; medical student; simulation-based learning; OSATS; low-resource setting; RCT

Outcome Measures

Primary Outcomes (1)

• Total OSATS Score (Objective Structured Assessment of Technical Skills)

  The OSATS score will assess practical suturing skills using a standardized checklist across multiple domains (e.g., instrument handling, suture technique, knot tying). Each item is scored on a 1-5 ordinal scale, and scores are summed to create a total OSATS score. The evaluation will be conducted by a blinded assessor based on video recordings. The total score will be treated as a continuous variable if normality is satisfied and will serve as the primary outcome in assessing non-inferiority between the online and in-person training groups.

  Within 2 days post-intervention

Secondary Outcomes (1)

• Knowledge Assessment Score (Pre/Post MCQ)

  Immediately before and after intervention (3 days total)

Study Arms (2)

In person suturing training

EXPERIMENTAL

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.

Other: Suturing training

Online suturing training

EXPERIMENTAL

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.

Other: Suturing training

Interventions

Suturing training 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.

Also known as: Suturing skills workshop

In person suturing training; Online suturing training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical students (Yarmouk university)
• Signed informed consent

You may not qualify if:

• Incomplete workshop attendance
• Technical issues that hinder full participation

Sponsors & Collaborators

• Diala Burjak: lead

Study Sites (1)

Jordan Medical Association

Irbid, 21110, Jordan

Location

Study Officials

• Diala Burjak, MD

  NYC Health + Hospitals/ Elmhurst Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 26, 2025
• Study Start: May 13, 2025
• Primary Completion: May 17, 2025
• Study Completion: May 17, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting documents (study protocol and informed consent form) will be made available within 6 months after publication of the primary results. Data will remain available for at least 3 years following release, or longer upon request.
• Access Criteria: Qualified researchers, academic institutions, or organizations conducting health education or surgical training research may request access to the IPD and supporting documentation. Requests should include a research proposal and intended use. Data will be shared in de-identified format upon approval by the Principal Investigator and may be transmitted via secure email or file-sharing platforms.

Locations

JO (1)