- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07678424
POV Video and Mental Practice Training for Neonatal LMA Insertion
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
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kahramanmaraş, Turkey (Türkiye), 46100
- Kahramanmaraş Sütçü İmam University, Faculty of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group A - Standard Demonstration
Participants receive a standardized, step-by-step 5-minute live instructor demonstration of neonatal laryngeal mask airway (LMA) insertion on a high-fidelity term neonatal simulator, adhering to current Neonatal Resuscitation Program (NRP) guidelines.
|
A 5-minute, step-by-step live instructor demonstration of neonatal LMA insertion on a simulator.
|
|
Experimental: Group B - POV Video + Mental Practice
Participants view a 3-minute standardized point-of-view (POV) video captured by a head-mounted action camera worn by an experienced instructor, displaying the LMA insertion from a first-person perspective with expert narration.
Immediately after, participants perform a 1-minute structured mental rehearsal.
|
A 3-minute first-person point-of-view video combined with 1 minute of structured mental rehearsal.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Objective Structured Clinical Examination (OSCE) Score
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.
|
Immediately after the educational intervention (Day 1).
|
|
Procedural Completion Time
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.
|
Immediately after the educational intervention (Day 1).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective Workload (NASA-TLX Score)
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.
|
Immediately after the clinical performance assessment (Day 1).
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KSUEK-2026/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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