Virtual RealityNCT06776211
Effectiveness of VR and LR Applications in Newborn Resuscitation Education
A study testing Virtual Reality Simulation and Low-Reality Simulation in people with Virtual Reality and Neonatal Resuscitation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This research was designed to investigate the effectiveness of virtual reality and low reality simulation applications in neonatal resuscitation skills training. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Neonatal Resuscitation, Simulation
- What is being tested?
- Virtual Reality Simulation and Low-Reality Simulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2025to 29 Aug 2025
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteer to participate in the research.
- Be an active student in the 4th year of the Midwifery Department of Hamidiye Health Sciences Faculty, University of Health Sciences.
- Attend theoretical classes regularly.
Who cannot join
- Being a passive student in the 4th year of the Midwifery Department of Hamidiye Health Sciences Faculty, University of Health Sciences.
- Not meeting the inclusion criteria.
- Having attended the Neonatal Resuscitation Certificate Training or Course.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Virtual Reality and Low-Reality Simulation Application in Neonatal Resuscitation Skills Training
This research was designed to investigate the effectiveness of virtual reality and low reality simulation applications in neonatal resuscitation skills training.
Read the detailed description
The research universe will consist of fourth year students studying at the Department of Midwifery, Hamidiye Faculty of Health Sciences (HSBF), Health Sciences University (SBU) in the academic year 2024-2025 (N: 80).
In the preparation phase of the research, the literature on neonatal resuscitation will be reviewed by the researchers and the topic will be translated into an 8-week power point presentation. The 2-hour training content will also include case discussion and video demonstration of skills.
Randomisation of the study Students who volunteer to participate in the study will be allocated to the intervention and control groups using computerised simple random sampling. The study will use computer-assisted randomisation and students will be randomly assigned to the intervention and control groups using the program with the URL address https://www.randomizer.org.
By dividing the students into two groups as Virtual Reality Simulation Application and Low Reality Simulation Application, the students will be given an "Introductory Information Form", "Neonatal Resuscitation Information Form" and "Neonatal Resuscitation Skill Assessment Form".
In this planned experimental pre-test and post-test design and control group study, students were divided into Virtual Reality (n₁=40) and Low Reality Simulation (n₂=40) groups.
Each stage of the study and any applications to be made will be explained and a voluntary informed consent form will be obtained from each student.
Students will be assessed 4 weeks after the pre-test, post-test and application.
- Conditions
- Virtual Reality, Neonatal Resuscitation, Simulation
- Being tested
- Virtual Reality Simulation, Low-Reality Simulation
- Keywords
- Neonatal Resuscitation, midwifery students, virtual reality, Simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality SimulationBehavioural
Virtual reality simulation application:
The video content to be used in the virtual reality-based application was created by researchers from the Ministry of Health of the Republic of Turkey, General Directorate of Public Health, Neonatal Resuscitation Programme (NRP) Practitioner Certified Training Programme. The duration of the video was planned not to exceed 10 minutes in order not to reduce the interest and attention span.
Low-Reality SimulationBehavioural
Low reality simulation application: The low reality simulation application to be used will use a neonatal model as a teaching aid, with human anatomy and functional features designed to simulate neonatal resuscitation applications.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Simulation | Experimental | Virtual reality simulation application:
The video content to be used in the virtual reality-based application was created by researchers from the Ministry of Health of the Republic of Turkey, General Directorate of Public Health, Neonatal Resuscitation Programme (NRP) Practitioner Certified Training Programme. The duration of the video was planned not to exceed 10 minutes in order not to reduce the interest and attention span. Receives: Behavioral: Virtual Reality Simulation |
| Low-Reality Simulation | Experimental | Low reality simulation application: The low reality simulation application to be used will use a neonatal model as a teaching aid, with human anatomy and functional features designed to simulate neonatal resuscitation applications. Receives: Behavioral: Low-Reality Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Resuscitation Information Form
This form, developed by researchers based on literature, includes questions designed to assess midwifery students' knowledge. The information form was also based on the General Directorate of Public Health's Neonatal Resuscitation Program (NRP) Certified Practitioner Training Program. The form consists of 30 questions and includes true/false responses. Percentage and frequency measurements will be used to evaluate the form. The final form was developed based on expert opinion.
Measured: Pre-test, immediately after participants were assigned to groups
Neonatal Resuscitation Information Form
It is based on the General Directorate of Public Health, Newborn Resuscitation/Neonatal Resuscitation Programme (NRP) Certified Practitioner Training Programme.
Measured: immediately after the pre-test
Neonatal Resuscitation Information Form
It is based on the General Directorate of Public Health, Newborn Resuscitation/Neonatal Resuscitation Programme (NRP) Certified Practitioner Training Programme.
Measured: Follow-up test, 4 weeks after the post-test was administered
Neonatal Resuscitation Skills Assessment Form
It is based on the General Directorate of Public Health, Newborn Resuscitation/Neonatal Resuscitation Programme (NRP) Certified Practitioner Training Programme.
Measured: Pre-test, immediately after participants were assigned to groups
Neonatal Resuscitation Skills Assessment Form
It is based on the General Directorate of Public Health, Newborn Resuscitation/Neonatal Resuscitation Programme (NRP) Certified Practitioner Training Programme.
Measured: immediately after the pre-test
Neonatal Resuscitation Skills Assessment Form
It is based on the General Directorate of Public Health, Newborn Resuscitation/Neonatal Resuscitation Programme (NRP) Certified Practitioner Training Programme.
Measured: Follow-up test, 4 weeks after the post-test was administered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start10 Jan 2025
- Primary completion29 Jul 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies 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
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Kaya, Saglik Bilimleri Universitesi
- Investigators
- Leyla Kaya, PhD, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776211
- Sponsor's protocol ID
- 17.12.2024-34256
- Status last verified
- Aug 2025
- First submitted
- 26 Dec 2024
- Last updated
- 2 Sep 2025
- 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 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality and Low-Reality Simulation Application in Neonatal Resuscitation Skills Training
- ClinicalTrials.gov ID
- NCT06776211
- Acronym / sponsor ID
- 17.12.2024-34256
- Conditions
- Virtual Reality, Neonatal Resuscitation, Simulation
- Keywords
- Neonatal Resuscitation, midwifery students, virtual reality, Simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 15 Jan 2025 (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 research was designed to investigate the effectiveness of virtual reality and low reality simulation applications in neonatal resuscitation skills training.
Detailed description
The research universe will consist of fourth year students studying at the Department of Midwifery, Hamidiye Faculty of Health Sciences (HSBF), Health Sciences University (SBU) in the academic year 2024-2025 (N: 80).
In the preparation phase of the research, the literature on neonatal resuscitation will be reviewed by the researchers and the topic will be translated into an 8-week power point presentation. The 2-hour training content will also include case discussion and video demonstration of skills.
Randomisation of the study Students who volunteer to participate in the study will be allocated to the intervention and control groups using computerised simple random sampling. The study will use computer-assisted randomisation and students will be randomly assigned to the intervention and control groups using the program with the URL address https://www.randomizer.org.
By dividing the students into two groups as Virtual Reality Simulation Application and Low Reality Simulation Application, the students will be given an "Introductory Information Form", "Neonatal Resuscitation Information Form" and "Neonatal Resuscitation Skill Assessment Form".
In this planned experimental pre-test and post-test design and control group study, students were divided into Virtual Reality (n₁=40) and Low Reality Simulation (n₂=40) groups.
Each stage of the study and any applications to be made will be explained and a voluntary informed consent form will be obtained from each student.
Students will be assessed 4 weeks after the pre-test, post-test and application.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Simulation | Experimental | Behavioral: Virtual Reality SimulationVirtual reality simulation application: The video content to be used in the virtual reality-based application was created by researchers from the Ministry of Health of the Republic of Turkey, General Directorate of Public Health, Neonatal Resuscitation Programme (NRP) Practitioner Certified Training Programme. The duration of the video was planned not to exceed 10 minutes in order not to reduce the interest and attention span. |
| Low-Reality Simulation | Experimental | Behavioral: Low-Reality SimulationLow reality simulation application: The low reality simulation application to be used will use a neonatal model as a teaching aid, with human anatomy and functional features designed to simulate neonatal resuscitation applications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteer to participate in the research.
- Be an active student in the 4th year of the Midwifery Department of Hamidiye Health Sciences Faculty, University of Health Sciences.
- Attend theoretical classes regularly.
Key exclusion criteria (3 listed)
- Being a passive student in the 4th year of the Midwifery Department of Hamidiye Health Sciences Faculty, University of Health Sciences.
- Not meeting the inclusion criteria.
- Having attended the Neonatal Resuscitation Certificate Training or Course.
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 |
|---|---|---|
| Virtual Reality SimulationVirtual reality simulation application: The video content to be used in the virtual reality-based application was created by researchers from the Ministry of Health of the Republic of Turkey, General Directorate of Public Health, Neonatal Resuscitation Programme (NRP) Practitioner Certified Training Programme. The duration of the video was planned not to exceed 10 minutes in order not to reduce the interest and attention span. | Behavioural | Virtual Reality Simulation |
| Low-Reality SimulationLow reality simulation application: The low reality simulation application to be used will use a neonatal model as a teaching aid, with human anatomy and functional features designed to simulate neonatal resuscitation applications. | Behavioural | Low-Reality Simulation |
Primary outcome
Neonatal Resuscitation Information Form
Time frame: Pre-test, immediately after participants were assigned to groups
This form, developed by researchers based on literature, includes questions designed to assess midwifery students' knowledge. The information form was also based on the General Directorate of Public Health's Neonatal Resuscitation Program (NRP) Certified Practitioner Training Program. The form consists of 30 questions and includes true/false responses. Percentage and frequency measurements will be used to evaluate the form. The final form was developed based on expert opinion.
Neonatal Resuscitation Information Form
Time frame: immediately after the pre-test
It is based on the General Directorate of Public Health, Newborn Resuscitation/Neonatal Resuscitation Programme (NRP) Certified Practitioner Training Programme.
Neonatal Resuscitation Information Form
Time frame: Follow-up test, 4 weeks after the post-test was administered
It is based on the General Directorate of Public Health, Newborn Resuscitation/Neonatal Resuscitation Programme (NRP) Certified Practitioner Training Programme.
Neonatal Resuscitation Skills Assessment Form
Time frame: Pre-test, immediately after participants were assigned to groups
It is based on the General Directorate of Public Health, Newborn Resuscitation/Neonatal Resuscitation Programme (NRP) Certified Practitioner Training Programme.
Neonatal Resuscitation Skills Assessment Form
Time frame: immediately after the pre-test
It is based on the General Directorate of Public Health, Newborn Resuscitation/Neonatal Resuscitation Programme (NRP) Certified Practitioner Training Programme.
Neonatal Resuscitation Skills Assessment Form
Time frame: Follow-up test, 4 weeks after the post-test was administered
It is based on the General Directorate of Public Health, Newborn Resuscitation/Neonatal Resuscitation Programme (NRP) Certified Practitioner Training Programme.
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 2 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Leyla Kaya, PhD principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Simulation and Low-Reality Simulation in people with Virtual Reality and Neonatal Resuscitation, run by Saglik Bilimleri Universitesi 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 2 Sep 2025. 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?
Neonatal Resuscitation Information Form (time frame: Pre-test, immediately after participants were assigned to groups). The study lists 6 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 2 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.