A Non-Inferiority Randomized Controlled Trial Comparing the Effectiveness of Online Versus In-Person Suturing Training Among Medical Students in a Low Resource Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Total OSATS Score (Objective Structured Assessment of Technical Skills)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medical students (Yarmouk university)
- •Signed informed consent
排除标准
- •Incomplete workshop attendance
- •Technical issues that hinder full participation
研究组 & 干预措施
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.
干预措施: Suturing training (Other)
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.
干预措施: Suturing training (Other)
结局指标
主要结局
Total OSATS Score (Objective Structured Assessment of Technical Skills)
时间窗: Within 2 days post-intervention
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.
次要结局
- Knowledge Assessment Score (Pre/Post MCQ)(Immediately before and after intervention (3 days total))
研究者
Diala Burjak
MD
Yarmouk University