NCT07678424

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2026

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

4 days

First QC Date

June 25, 2026

Last Update Submit

June 25, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Objective Structured Clinical Examination (OSCE) Score

    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

    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 Outcomes (1)

  • Subjective Workload (NASA-TLX Score)

    Immediately after the clinical performance assessment (Day 1).

Study Arms (2)

Group A - Standard Demonstration

ACTIVE COMPARATOR

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.

Other: Standard Instructor Demonstration

Group B - POV Video + Mental Practice

EXPERIMENTAL

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.

Other: POV Video and Mental Practice

Interventions

A 5-minute, step-by-step live instructor demonstration of neonatal LMA insertion on a simulator.

Group A - Standard Demonstration

A 3-minute first-person point-of-view video combined with 1 minute of structured mental rehearsal.

Group B - POV Video + Mental Practice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü İmam University, Faculty of Medicine

Kahramanmaraş, 46100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology and Reanimation

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 1, 2026

Study Start

June 15, 2026

Primary Completion

June 19, 2026

Study Completion

June 19, 2026

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations