Neonatal ResuscitationNCT07678424
POV Video and Mental Practice Training for Neonatal LMA Insertion
A study testing Standard Instructor Demonstration and POV Video and Mental Practice in people with Neonatal Resuscitation and Clinical Competence, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neonatal Resuscitation, Clinical Competence, Simulation Training
- What is being tested?
- Standard Instructor Demonstration and POV Video and Mental Practice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to 19 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmam University, Faculty of Medicine
Kahramanmaraş, 46100
About this study
Official title: 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.
- Being tested
- Standard Instructor Demonstration, POV Video and Mental Practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Instructor DemonstrationOther
A 5-minute, step-by-step live instructor demonstration of neonatal LMA insertion on a simulator.
POV Video and Mental PracticeOther
A 3-minute first-person point-of-view video combined with 1 minute of structured mental rehearsal.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: POV Video and Mental Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Immediately after the educational intervention (Day 1).
Secondary outcomes (1)
Subjective Workload (NASA-TLX Score)
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.
Measured: Immediately after the clinical performance assessment (Day 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start15 Jun 2026
- Primary completion19 Jun 2026
- Study completion19 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cengizhan Yavuz, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678424
- Sponsor's protocol ID
- KSUEK-2026/18
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07678424
- Acronym / sponsor ID
- KSUEK-2026/18
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 19 Jun 2026 (actual)
- Study completion
- 19 Jun 2026 (actual)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Standard Demonstration | Active comparator | Other: Standard Instructor DemonstrationParticipants 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. |
| Group B - POV Video + Mental Practice | Experimental | Other: POV Video and Mental PracticeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Instructor DemonstrationA 5-minute, step-by-step live instructor demonstration of neonatal LMA insertion on a simulator. | Other | Group A - Standard Demonstration |
| POV Video and Mental PracticeA 3-minute first-person point-of-view video combined with 1 minute of structured mental rehearsal. | Other | Group B - POV Video + Mental Practice |
Primary outcome
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.
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.
1 secondary outcome
Subjective Workload (NASA-TLX Score)
Time frame: Immediately after the clinical performance assessment (Day 1).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Neonatal Resuscitation
Recruiting
The Periviable GOALS Decision Support Tool
Pregnancy Preterm, Premature Birth
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Not yet recruiting
Sustained Inflation and Chest Compression vs 3:1 C:V Ratio in Asphyxiated Newborns
Cardiac Arrest
Enrolling by invitationObservational study
Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage
Hypofibrinogenemia, Hemorrhage
Recruiting
Video-Based Self-Assessment in Neonatal Resuscitation Training
Neonatal Resuscitation, Simulation-Based Education
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Instructor Demonstration and POV Video and Mental Practice in people with Neonatal Resuscitation and Clinical Competence, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Structured Clinical Examination (OSCE) Score (time frame: Immediately after the educational intervention (Day 1).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.