- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06776211
Effectiveness of VR and LR Applications in Newborn Resuscitation Education
Effectiveness of Virtual Reality and Low-Reality Simulation Application in Neonatal Resuscitation Skills Training
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey (Türkiye), 34668
- University of Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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 |
|---|---|
|
Experimental: Virtual Reality Simulation
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. |
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. |
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Experimental: Low-Reality Simulation
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neonatal Resuscitation Information Form
Time Frame: Follow-up test, 4 weeks after the post-test was administered
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It is based on the General Directorate of Public Health, Newborn Resuscitation/Neonatal Resuscitation Programme (NRP) Certified Practitioner Training Programme.
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Follow-up test, 4 weeks after the post-test was administered
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Neonatal Resuscitation Skills Assessment Form
Time Frame: Pre-test, immediately after participants were assigned to groups
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It is based on the General Directorate of Public Health, Newborn Resuscitation/Neonatal Resuscitation Programme (NRP) Certified Practitioner Training Programme.
|
Pre-test, immediately after participants were assigned to groups
|
|
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.
|
Follow-up test, 4 weeks after the post-test was administered
|
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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.
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Pre-test, immediately after participants were assigned to groups
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Neonatal Resuscitation Information Form
Time Frame: immediately after the pre-test
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It is based on the General Directorate of Public Health, Newborn Resuscitation/Neonatal Resuscitation Programme (NRP) Certified Practitioner Training Programme.
|
immediately after the pre-test
|
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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.
|
immediately after the pre-test
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leyla Kaya, PhD, Saglik Bilimleri Universitesi
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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 17.12.2024-34256
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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