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临床试验/NCT07678424
NCT07678424已完成不适用

Combined Use of Point-of-View (POV) Video and Mental Practice Training Versus Standard Demonstration for Neonatal LMA Insertion by Novice Healthcare Professionals: A Prospective Randomized Simulation Study

Kahramanmaras Sutcu Imam University1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2026年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Objective Structured Clinical Examination (OSCE) Score

研究概览

简要总结

This prospective, randomized, single-blind simulation study aims to evaluate and compare the educational efficacy of a hybrid instructional modality-combining point-of-view (POV) video training and structured mental practice (MP)-against standard instructor-led live demonstration for neonatal laryngeal mask airway (LMA) insertion training among novice healthcare professionals. Learning neonatal airway management skills presents unique educational and cognitive challenges, especially for non-physician providers who are frequently required to perform these high-stakes interventions during the Neonatal Resuscitation Program (NRP) curricula.

A total of 52 eligible healthcare professionals (including physicians, midwives, nurses, paramedics, and emergency medical technicians) with no prior neonatal LMA insertion experience will be prospectively enrolled and randomly allocated into two equal parallel groups (n=26 per group). Group A (Control) will receive a standard, step-by-step 5-minute live instructor demonstration on a high-fidelity term neonatal simulator. Group B (Intervention) will view a 3-minute standardized POV video captured from a first-person perspective via a head-mounted action camera worn by an expert instructor, immediately followed by a 1-minute structured mental rehearsal, with no live demonstration provided.

Following the respective educational interventions, all participants will individually perform the neonatal LMA insertion on the simulator in a separate room. A trained evaluator, who remains strictly blinded to the group assignments, will record the performance outcomes. The primary outcome measures are the objective total OSCE score (evaluated via a 22-item standardized checklist) and the physical procedural completion time in seconds. Secondary outcomes include first-attempt success rates, critical error rates, instances of excessive force application, airway trauma or procedural failure, and subjective cognitive workload dimensions assessed via the NASA Task Load Index (NASA-TLX) questionnaire. The findings will provide insights into scalable, cost-effective, and cognitively optimized learning models for integration into neonatal resuscitation training frameworks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being a licensed healthcare professional (physicians, midwives, nurses, paramedics, or emergency medical technicians) currently participating in or eligible for the Neonatal Resuscitation Program (NRP) training.
  • Having no prior practical, clinical, or simulator-based experience with neonatal laryngeal mask airway (LMA) insertion.
  • Voluntarily consenting to participate in the study and complete all evaluation procedures (OSCE and NASA-TLX).

排除标准

  • Having previous hands-on experience or formal advanced training specifically in neonatal LMA stabilization or insertion.
  • Declining to participate or failing to complete any phase of the allocated educational intervention or subsequent assessment.
  • Having visual, auditory, or cognitive impairments that would interfere with viewing the point-of-view (POV) video or performing the structured mental practice.

结局指标

主要结局

Objective Structured Clinical Examination (OSCE) Score

时间窗: Immediately after the educational intervention (Day 1).

A 22-item standardized checklist specifically developed based on the Neonatal Resuscitation Program (NRP) guidelines to evaluate the technical proficiency of neonatal laryngeal mask airway (LMA) insertion. Each step is scored, and higher total scores indicate superior clinical performance.

Procedural Completion Time

时间窗: Immediately after the educational intervention (Day 1).

The total physical time measured in seconds from the moment the participant picks up the laryngeal mask airway (LMA) device until the successful placement and initial ventilation on the high-fidelity neonatal simulator.

次要结局

  • Subjective Workload (NASA-TLX Score)(Immediately after the clinical performance assessment (Day 1).)

研究者

发起方
Kahramanmaras Sutcu Imam University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cengizhan Yavuz

Assistant Professor of Anesthesiology and Reanimation

Kahramanmaras Sutcu Imam University

研究点 (1)

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