Kahramanmaraş Sütçü İmam University, Faculty of Medicine
Kahramanmaraş, 46100, Turkey (Türkiye)
NCT Number: NCT07678424
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Kahramanmaraş, 46100, Turkey (Türkiye)
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A 5-minute, step-by-step live instructor demonstration of neonatal LMA insertion on a simulator.
A 3-minute first-person point-of-view video combined with 1 minute of structured mental rehearsal.
Time frame: 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.
Time frame: 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.
Time frame: Immediately after the clinical performance assessment (Day 1).
The NASA Task Load Index (NASA-TLX) questionnaire will be used to evaluate the multidimensional subjective workload experienced by participants across 6 subscales: mental demand, physical demand, temporal demand, performance, effort, and frustration. Total score ranges from 0 to 100, where higher scores reflect higher cognitive and physical workload.
Kahramanmaras Sutcu Imam University
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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