Nurse's RoleNCT04746898
Effectiveness Of Different Simulation Methods As A Training Strategy In Basic Life Support
A study testing Virtual Reality Training, High Fidelity Simulation Training and Low Fidelity Simulation Training in people with Nurse's Role and Simulation Training, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
The experimentally planned research was carried out with the students of Zonguldak Bülent Ecevit University Faculty of Health Sciences Nursing Department between 21.02.2020-02.09.2020.After the informed consent form was obtained from the students who accepted to participate in the study, the students were divided into… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role, Simulation Training, Cardiopulmonary Resuscitation
- What is being tested?
- Virtual Reality Training, High Fidelity Simulation Training and Low Fidelity Simulation Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Feb 2020to 18 Feb 2021
- 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
- Volunteering to participate the study,
- Having taken basic nursing education courses,
- Passing the Basic Principles and Practices in Nursing Course with a letter grade of CB and above
- Having taken basic English courses,
- Not having received first aid training before,
- To be able to speak and understand the Turkish language,
- Ability to use technological devices
Who cannot join
- Not wanting to participate in the study,
- Not taking basic nursing education courses,
- Getting CC and under letter grade from Basic Principles and Practices in Nursing course
- Not taking basic English lessons,
- Having received first aid training before,
- Inability to speak and understand Turkish language adequately,
- Inability to use technological devices
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University
Zonguldak, Merkez, 67100
About this study
Official title: Effectiveness Of Different Simulation Methods As A Training Strategy In Basic Life Support In Increasing Knowledge And Skills: A Randomised Control Trial
The experimentally planned research was carried out with the students of Zonguldak Bülent Ecevit University Faculty of Health Sciences Nursing Department between 21.02.2020-02.09.2020.After the informed consent form was obtained from the students who accepted to participate in the study, the students were divided into three groups by applying block randomization with the computer-assisted randomization method. Then, all students filled in the Participant Identification Form and the Basic Life Support Application Steps for Adults Information Form. Later, with a visual-based presentation prepared in line with the guideline updated and published by the American Heart Association (AHA) in 2015, a 30-minute training on basic life support for adults was given.At the end of the training, the students were informed about the groups they were in, and the working principles of the devices the groups would work on were informed. With the first group virtual reality applied scenario, the 2nd group computer-aided scenario-based high-reality simulation device (SimMan® 3G) and the 3rd group low-reality adult basic life support model.The groups will be taken to the laboratories individually and the applications will be done individually and other students were not allowed to follow the student who did the application during the application. During the application, the students were evaluated with the basic life support application evaluation form. During the application, the video recording taken with the permission of the students was watched with the student after the application and a debriefing session was held. After the application, education was evaluated with Student Satisfaction and Self-Confidence in Learning Scale. Basic life support knowledge level was evaluated by having the basic life support information assessment form filled out again at 3 and 6 months after the first evaluation.
Read the detailed description
Cardiac arrest is an important health problem and cause death all over the world. In the event of an arrest, the initiation of emergency resuscitation increases survival rates by 3-fold. Although basic life support is vital, unfortunately the level of knowledge on the subject is quite low. When the nursing programs are examined, it is seen that the first aid emergency care course is included in the nursing undergraduate education plan of Higher Education Institutions Core Program. It is seen that theoretical and clinical applications are carried out in the scope of First Aid and Emergency Care Nursing course.
Clinical practice is an essential part of nursing education. However, during clinical practice, factors such as inadequacy of clinical application areas, not feeling ready for students, fear of harming the patient and making mistakes, increasing student / instructor ratio increase the anxiety levels of students and thus prevent students from making patient care correctly and completely. During clinical practice, students should realize their practices by paying attention to the values and rights of the patients and it is very important to ensure patient safety.
Technological advances, which allow for the recurrence of clinical skills and the opportunity to experience rare clinical conditions, enable students to work with models that act as real patients in environments similar to actual clinical settings. While providing this, it is a teaching method that maintains the safety of the patient, improves the ability of skill by learning and provides learning opportunity without fear of harm to the patient. However, there are many positive features such as increasing students' motivation, encouraging learning and increasing self-confidence. Computer-aided simulation and virtual reality applications developed within the scope of experience-based teaching design are enriched with feedback and increase learning outcomes. Considering all these, the use of simulation practices and tools in nursing education is rapidly increasing.
The didactic teaching and learned procedures, which are among the various advantages of simulations, are considered as a learning tool that will increase the success in healthcare practices, thanks to the opportunity to apply them to patients. However, expensive simulators that are dependent on teaching in terms of design, space and feedback have accessibility problems. For this reason, this study has been planned in order to determine the method required to ensure effective education of vital first aid applications and firstly the basic life support application and to determine the most effective method to ensure the best integration into education in this rapidly advancing period of technology.
- Being tested
- Virtual Reality Training, High Fidelity Simulation Training, Low Fidelity Simulation Training
- Keywords
- Nurse, Simulation Training, Virtual Reality, High Fidelity Simulation, Cardiopulmonary Resuscitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality TrainingOther
Also called High Fidelity Simulation Training
Students received their basic life support application training through virtual reality glasses with special software.
High Fidelity Simulation TrainingOther
Students received their basic life support application training through high fidelity simulator mannequins.
Low Fidelity Simulation TrainingOther
Also called Traditional Method
Students received their basic life support application training through low fidelity simulator mannequins.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Training Group (VR group) | Experimental | The students in the first group received basic life support practice training with virtual reality applications. Receives: Other: Virtual Reality Training |
| High Fidelity Simulation Training Group (HFS group) | Experimental | The students in the second group received basic life support practice training with high fidelity simulators. Receives: Other: High Fidelity Simulation Training |
| Low Fidelity Simulation Training Group (LFS group) | Experimental | The students in the third group received basic life support practice training with the classical method, low-reality mannequin. Receives: Other: Low Fidelity Simulation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreasing mortality and morbidity rates by increasing knowledge and skills of basic life support.
Unfortunately, the level of knowledge of health professionals about the essential life support application is very low. Nursing students who are highly likely to encounter patients with basic life support indications due to their professions will have a positive effect on survival rates if they graduate competently on this subject.
Measured: 6 months
To determine the most effective method by evaluating students' knowledge level on the subject with the basic life support information assessment form
Technological developments that allow the repetition of clinical skills and the opportunity to experience rare clinical situations offer students the opportunity to work with models that behave like real patients in environments similar to real clinical settings. Determining the effective method in the education of a practice that is of vital importance such as basic life support will contribute to the effective increase of knowledge and skills of healthcare professionals and students studying in this field. The knowledge level of students about basic life support will be evaluated with a knowledge assessment form.
Measured: 6 months
Determining an effective education method by evaluating basic life support practice skills after the education of students with different simulation methods.
The basic life support training of the students was applied with different simulation methods. After the training, the basic life support practice skills of the students were evaluated with the practice evaluation form prepared according to the AHA 2015 guide. Determining the effective method will contribute to the effective acquisition of practical skills to students.
Measured: 6 months
To increase students' self-confidence and satisfaction levels about the practice after basic life support practice training
The students of our age, known as the generation Z, grow up with technology. The integration of different technological developments into education attracts their attention and increases their motivation. This increases students' self-confidence and satisfaction levels after training. Increasing satisfaction and self-confidence increases students' interest in education and their learning capacity. Thus, the acquisition and permanence of information on the subject increases. Student Satisfaction and Self-Confidence Scale was used to measure students' levels of satisfaction and self-confidence. The highest score that can be obtained from the scale is 65 and the lowest score is 13. High score that can be obtained from the total of the scale indicates high satisfaction and self-confidence.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start21 Feb 2020
- Primary completion2 Sep 2020
- Study completion18 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nurse's RoleStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Collaborators
- Nurten Taşdemir Assoc. Prof. PhD.
- Responsible party
- Principal investigator, Dilek YILDIRIM TANK, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746898
- Sponsor's protocol ID
- ZonguldakBEU
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2021
- Last updated
- 12 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Aqel AA, Ahmad MM. High-fidelity simulation effects on CPR knowledge, skills, acquisition, and retention in nursing students. Worldviews Evid Based Nurs. 2014 Dec;11(6):394-400. doi: 10.1111/wvn.12063. Epub 2014 Sep 11.
PubMed 25213578
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Different Simulation Methods As A Training Strategy In Basic Life Support In Increasing Knowledge And Skills: A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT04746898
- Acronym / sponsor ID
- ZonguldakBEU
- Keywords
- Nurse, Simulation Training, Virtual Reality, High Fidelity Simulation, Cardiopulmonary Resuscitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Collaborators
- Nurten Taşdemir Assoc. Prof. PhD.
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 18 Feb 2021 (estimated)
- First posted
- 10 Feb 2021 (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.
The experimentally planned research was carried out with the students of Zonguldak Bülent Ecevit University Faculty of Health Sciences Nursing Department between 21.02.2020-02.09.2020.After the informed consent form was obtained from the students who accepted to participate in the study, the students were divided into three groups by applying block randomization with the computer-assisted randomization method. Then, all students filled in the Participant Identification Form and the Basic Life Support Application Steps for Adults Information Form. Later, with a visual-based presentation prepared in line with the guideline updated and published by the American Heart Association (AHA) in 2015, a 30-minute training on basic life support for adults was given.At the end of the training, the students were informed about the groups they were in, and the working principles of the devices the groups would work on were informed. With the first group virtual reality applied scenario, the 2nd group computer-aided scenario-based high-reality simulation device (SimMan® 3G) and the 3rd group low-reality adult basic life support model.The groups will be taken to the laboratories individually and the applications will be done individually and other students were not allowed to follow the student who did the application during the application. During the application, the students were evaluated with the basic life support application evaluation form. During the application, the video recording taken with the permission of the students was watched with the student after the application and a debriefing session was held. After the application, education was evaluated with Student Satisfaction and Self-Confidence in Learning Scale. Basic life support knowledge level was evaluated by having the basic life support information assessment form filled out again at 3 and 6 months after the first evaluation.
Detailed description
Cardiac arrest is an important health problem and cause death all over the world. In the event of an arrest, the initiation of emergency resuscitation increases survival rates by 3-fold. Although basic life support is vital, unfortunately the level of knowledge on the subject is quite low. When the nursing programs are examined, it is seen that the first aid emergency care course is included in the nursing undergraduate education plan of Higher Education Institutions Core Program. It is seen that theoretical and clinical applications are carried out in the scope of First Aid and Emergency Care Nursing course.
Clinical practice is an essential part of nursing education. However, during clinical practice, factors such as inadequacy of clinical application areas, not feeling ready for students, fear of harming the patient and making mistakes, increasing student / instructor ratio increase the anxiety levels of students and thus prevent students from making patient care correctly and completely. During clinical practice, students should realize their practices by paying attention to the values and rights of the patients and it is very important to ensure patient safety.
Technological advances, which allow for the recurrence of clinical skills and the opportunity to experience rare clinical conditions, enable students to work with models that act as real patients in environments similar to actual clinical settings. While providing this, it is a teaching method that maintains the safety of the patient, improves the ability of skill by learning and provides learning opportunity without fear of harm to the patient. However, there are many positive features such as increasing students' motivation, encouraging learning and increasing self-confidence. Computer-aided simulation and virtual reality applications developed within the scope of experience-based teaching design are enriched with feedback and increase learning outcomes. Considering all these, the use of simulation practices and tools in nursing education is rapidly increasing.
The didactic teaching and learned procedures, which are among the various advantages of simulations, are considered as a learning tool that will increase the success in healthcare practices, thanks to the opportunity to apply them to patients. However, expensive simulators that are dependent on teaching in terms of design, space and feedback have accessibility problems. For this reason, this study has been planned in order to determine the method required to ensure effective education of vital first aid applications and firstly the basic life support application and to determine the most effective method to ensure the best integration into education in this rapidly advancing period of technology.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Training Group (VR group) | Experimental | Other: Virtual Reality TrainingThe students in the first group received basic life support practice training with virtual reality applications. |
| High Fidelity Simulation Training Group (HFS group) | Experimental | Other: High Fidelity Simulation TrainingThe students in the second group received basic life support practice training with high fidelity simulators. |
| Low Fidelity Simulation Training Group (LFS group) | Experimental | Other: Low Fidelity Simulation TrainingThe students in the third group received basic life support practice training with the classical method, low-reality mannequin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Volunteering to participate the study,
- Having taken basic nursing education courses,
- Passing the Basic Principles and Practices in Nursing Course with a letter grade of CB and above
- Having taken basic English courses,
- Not having received first aid training before,
Key exclusion criteria (7 listed)
- Not wanting to participate in the study,
- Not taking basic nursing education courses,
- Getting CC and under letter grade from Basic Principles and Practices in Nursing course
- Not taking basic English lessons,
- Having received first aid training before,
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 TrainingAlso: High Fidelity Simulation TrainingStudents received their basic life support application training through virtual reality glasses with special software. | Other | Virtual Reality Training Group (VR group) |
| High Fidelity Simulation TrainingStudents received their basic life support application training through high fidelity simulator mannequins. | Other | High Fidelity Simulation Training Group (HFS group) |
| Low Fidelity Simulation TrainingAlso: Traditional MethodStudents received their basic life support application training through low fidelity simulator mannequins. | Other | Low Fidelity Simulation Training Group (LFS group) |
Primary outcome
Decreasing mortality and morbidity rates by increasing knowledge and skills of basic life support.
Time frame: 6 months
Unfortunately, the level of knowledge of health professionals about the essential life support application is very low. Nursing students who are highly likely to encounter patients with basic life support indications due to their professions will have a positive effect on survival rates if they graduate competently on this subject.
To determine the most effective method by evaluating students' knowledge level on the subject with the basic life support information assessment form
Time frame: 6 months
Technological developments that allow the repetition of clinical skills and the opportunity to experience rare clinical situations offer students the opportunity to work with models that behave like real patients in environments similar to real clinical settings. Determining the effective method in the education of a practice that is of vital importance such as basic life support will contribute to the effective increase of knowledge and skills of healthcare professionals and students studying in this field. The knowledge level of students about basic life support will be evaluated with a knowledge assessment form.
Determining an effective education method by evaluating basic life support practice skills after the education of students with different simulation methods.
Time frame: 6 months
The basic life support training of the students was applied with different simulation methods. After the training, the basic life support practice skills of the students were evaluated with the practice evaluation form prepared according to the AHA 2015 guide. Determining the effective method will contribute to the effective acquisition of practical skills to students.
To increase students' self-confidence and satisfaction levels about the practice after basic life support practice training
Time frame: 6 months
The students of our age, known as the generation Z, grow up with technology. The integration of different technological developments into education attracts their attention and increases their motivation. This increases students' self-confidence and satisfaction levels after training. Increasing satisfaction and self-confidence increases students' interest in education and their learning capacity. Thus, the acquisition and permanence of information on the subject increases. Student Satisfaction and Self-Confidence Scale was used to measure students' levels of satisfaction and self-confidence. The highest score that can be obtained from the scale is 65 and the lowest score is 13. High score that can be obtained from the total of the scale indicates high satisfaction and self-confidence.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Background: PubMed 25213578Aqel AA, Ahmad MM. High-fidelity simulation effects on CPR knowledge, skills, acquisition, and retention in nursing students. Worldviews Evid Based Nurs. 2014 Dec;11(6):394-400. doi: 10.1111/wvn.12063. Epub 2014 Sep 11.
- Individual participant dataSharing planned: Yes
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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.
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 Virtual Reality Training, High Fidelity Simulation Training and Low Fidelity Simulation Training in people with Nurse's Role and Simulation Training, run by Zonguldak Bulent Ecevit 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Feb 2021. 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?
Results are not available in the source record.
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?
Decreasing mortality and morbidity rates by increasing knowledge and skills of basic life support. (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04746898, which also lists 1 linked publication.
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 12 Feb 2021; AzTrials last refreshed its copy on 26 Oct 2026.