Simulation-Enhanced Blended Learning Versus Traditional See One, Do One Approach for Training Clinical Procedural Skills: A Randomized Non-Inferiority Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
Mastery of clinical procedural skills is essential in medical practice, especially at various stages of training, and their acquisition is the core objectives. Conventional training methods, particularly the ’see one, do one’ (SODO) approach, remain widely used. In this model, learners first observe a procedure performed by an experienced clinician and then perform it themselves under supervision. Although effective, this approach has notable limitations, including restricted opportunities for repeated practice, variability in patient presentations, and inherent risks of patient harm when procedures are performed by novices (Facilitating flexible learning by replacing classroom time with an online learning environment: a systematic review of blended learning in higher education) (Mccutcheon et al., 2015) These concerns are underscored by ethical guidelines such as the Declaration of Helsinki, which emphasizes the necessity of informed consent and the minimization of risk in medical training involving human subjects. In conventional offline lectures, the predominant model of unidirectional knowledge delivery by instructors often limits the capacity to address students’ holistic learning needs. Conversely, entirely online teaching, even with advanced information technology integration, can leave learners with excessive autonomy and may compromise the consistency and quality of educational outcomes (Müller & Mildenberger, 2021). Blended learning along with simulation, combines cognitive domain with psychomotor domain of medical education, facilitating a more dynamic and interactive educational experience, (Li et al., 2025; Mccutcheon et al., 2015).
Although blended learning has advanced rapidly, its optimal implementation strategies and measurable effectiveness remain subjects of debate. Evidence suggests that blended learning may enhance medical education (Rowe et al., 2012) and undergraduate procedural training programs by integrating cognitive outcomes, supporting individualized learning trajectories, and fostering greater learner confidence and self-efficacy compared with conventional teaching method (Lee et al., 2023). This approach aims to provide a comprehensive learning experience that caters to diverse learning styles and enhances the acquisition of essential clinical skills. In the realm of procedural training, particularly for complex tasks such as intravenous (IV) cannulation, arterial puncture for blood gas analysis, endotracheal tube (ETT) intubation, and supraglottic airway devices insertion, traditional methods such as SODO technique often used but recently come to scrutiny due to associated patient harm. Blended Learning with simulation offers a potential solution by providing a flexible and scalable model that incorporates digital learning and simulation to replace traditional training.
Simulation-based education (SBE) is widely acknowledged for its effectiveness in enhancing procedural competencies, offering learners a risk-free environment to practice clinical skills. Evidence indicates that SBE not only improves technical proficiency but also increases learner confidence and facilitates repeated practice, which is often constrained in real-world clinical settings (Elendu et al., 2024)The incorporation of digital e-learning modules further supports self-directed learning, allowing learners to engage with content at their own pace and consolidate theoretical knowledge. Blended learning (BL) approaches have been shown in some studies to yield comparable or even superior outcomes in skill acquisition and learner satisfaction (Govindan et al., 2023)Conversely, other findings suggest that without adequate integration and institutional support, BL may fall short of its potential. Consequently, rigorous evaluation of BL against traditional educational methods is essential to establish its effectiveness and suitability as a standard approach in medical training.
To address this gap in the literature, we plan to evaluate whether Blended Learning, encompassing digital e-learning modules and simulation-based training, is non-inferior to traditional SODO technique for essential skills among medical interns and anaesthesia trainees. This study will provide evidence that supports the integration of Blended Learning into medical training curricula, potentially enhancing the efficiency and accessibility of procedural education.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Medical Professional Inclusion Criteria
- •Willingness to participate
- •Ability to complete both instructional and assessment components Patient Inclusion Criteria 1.Adult patients aged 18 to 65 years.
- •2.Patients scheduled for elective surgical or diagnostic procedures in which one or more of the following procedures are indicated as part of routine standard of care: oIntravenous cannulation oArterial puncture for blood gas analysis oAirway management, including endotracheal intubation or laryngeal mask airway (LMA) insertion 3.Patients undergoing procedures under general anaesthesia or monitored anaesthesia care, in accordance with established institutional protocols.
- •4.Patients who have received a Patient Information Sheet detailing the study objectives and the involvement of supervised trainees, and who have provided written informed consent for participation.
- •5.Patients deemed clinically appropriate for trainee-performed procedures, as determined by the supervising consultant anaesthesiologist, with no anticipated increase in risk compared with routine practice.
排除标准
- •1.Refusal to participate or inability to provide informed consent.
- •2.Patients requiring emergency or urgent interventions, where trainee involvement may compromise timely clinical management.
- •3.Patients classified as ASA physical status III or higher.
- •4.Presence of a known or anticipated difficult airway, including but not limited to Mallampati class III or IV, limited mouth opening, cervical spine instability, or prior documentation of difficult intubation.
- •5.History of multiple unsuccessful attempts at intravenous cannulation or arterial puncture, or presence of conditions that significantly increase procedural risk, including: oSevere peripheral vascular disease oKnown coagulopathy or bleeding disorders oLocal infection, inflammation, or trauma at the intended procedural site 6.Patients requiring advanced, non-routine, or rescue airway techniques beyond standard endotracheal intubation or LMA insertion.
- •7.Pregnant patients, due to altered physiological considerations and heightened ethical safeguards.
- •8.Patients with hemodynamic or cardiorespiratory instability, or those considered to be at high anaesthetic risk, as assessed by the attending anaesthesiologist.
- •9.Patients concurrently enrolled in another interventional clinical study involving procedural or anaesthetic outcomes, where participation could introduce confounding or additional risk.
研究者
Dr Subodh Kumar
AIIMS
