Nursing CariesNCT05343221
The Effect of Haptic and Highly Fidelity Simulator in Cardiopulmonary Resuscitation Training
A study testing High Fidelity Simulator and Haptic in people with Nursing Caries and Cardiopulmonary Resuscitation, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Cardiopulmonary Resuscitation (CPR) is of great importance for nurses who frequently encounter cardiopulmonary arrest in health care institutions and who are within their duties, authorities and responsibilities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries, Cardiopulmonary Resuscitation
- What is being tested?
- High Fidelity Simulator and Haptic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2022to 2 Oct 2022
- 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
- Over18 years old
- Being 4nd year student
- Volunteering to take a CPR training
- who agreed to participate in the study in written and verbal form,
- participated in all phases of the study will be included.
Who cannot join
- Not being volunteer to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences
Istanbul, Uskudar
About this study
Official title: The Effect of Haptic and Highly Fidelity Simulator Use on Knowledge, Skills, Satisfaction and Self-Confidence Levels in Cardiopulmonary Resuscitation Training: A Randomized Controlled Study
Cardiopulmonary Resuscitation (CPR) is of great importance for nurses who frequently encounter cardiopulmonary arrest in health care institutions and who are within their duties, authorities and responsibilities. Therefore, nurses should have sufficient, up-to-date knowledge and skills about cardiopulmonary resuscitation. Nursing educators should try different training methods on CPR education and ensure that the student has sufficient knowledge and skills before graduation. This study, In order to examine the effects of haptic and highly fidelity simulator use in Cardiopulmonary Resuscitation training in nursing students on their knowledge, skills, satisfaction and self-confidence levels, it was planned to be performed in a randomized controlled type.
Read the detailed description
This study aim to examine the effects of Haptic and Highly Fidelity Simulator use in Cardiopulmonary Resuscitation training in nursing students on their knowledge, skills, satisfaction and self-confidence levels, it was planned to be performed in a randomized controlled type.
The population of the research will be 4th grade students enrolled in the Faculty of Health Sciences, Faculty of Nursing . The sample of the study will consist of all 4th grade students who meet the sample selection criteria.
Sampling Inclusion Criteria: Individuals over the age of 18, who agreed to participate in the study in written and verbal form, and participated in all phases of the study will be included.
In the randomization part of the study, the students will assigned to the experiment (n=30) and control (n=30) groups according to their number in the class list using the random numbers table.
Data will collect with "Sociodemographic Data Form", "Cardiopulmonary Resuscitation Knowledge Test", "Cardiopulmonary Resuscitation Skills Checklist" and "Student Satisfaction and Confidence in Learning Scale".
Written permission will be obtained from the individuals who volunteered to participate in the study, and "Sociodemographic Data Form" and "Cardiopulmonary Resuscitation Knowledge Test" will be applied to all students.
Cardiopulmonary Resuscitation training will be given theoretically to all students in the classroom environment by an expert academician who has an associate professor in the field of Surgical Nursing. This training will take 1 hour.
The names of all students will be written in alphabetical order, and students will be divided into "Haptic" or "Highly Fidelity Simulator" groups using the random numbers table.
Intervention in Haptic Group: Students will perform Cardiopulmonary resuscitation using 3D Systems Touch Haptic Simulator. During the intervention, there will be 2 researchers and the student who made the application in the room. While one of the researchers will be with the student only for support during the practice, the other researcher will fill the "Cardiopulmonary Resuscitation Skills Checklist" by evaluating the cardiopulmonary resuscitation skill of the student.
Intervention in the High Fidelity Simulator Group: Students will perform Cardiopulmonary resuscitation using High Fidelity CPR Simulator. During the intervention, there will be 2 researchers and the student who made the application in the room. While one of the researchers will be with the student only for support during the practice, the other researcher will fill the "Cardiopulmonary Resuscitation Skills Checklist" by evaluating the cardiopulmonary resuscitation skill of the student. The application of the student will take a total of 10 minutes.
- Conditions
- Nursing Caries, Cardiopulmonary Resuscitation
- Being tested
- High Fidelity Simulator, Haptic
- Keywords
- Haptic, Highly Fidelity Simulator, Skills, Satisfaction, Training
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Fidelity SimulatorDevice
First of all, students will be given 1 hour of CPR training. Then they will be asked to apply with the High Fidelity CPR Simulator. This simulator is adult human sized and specialized for CPR practice. It will not be interfered during the application. The student's practice will be evaluated by an observer. The student will evaluate his/her satisfaction after the application is over.
HapticDevice
First of all, students will be given 1 hour of CPR training. Then they will be asked to apply with the 3D technology Haptic Device Simulator. This tool has a computer screen and a swing haptic pen. It will not be interfered during the application. The student's practice will be evaluated by an observer. The student will evaluate his/her satisfaction after the application is over.
| Study group | Role | What they receive |
|---|---|---|
| Haptic | Experimental | Practice in Haptic Group: Students will be taught cardiopulmonary resuscitation skills with the 3D Systems Touch Haptic Simulator. During the application, there will be 2 researchers and the student who made the application in the room. While one of the researchers will be with the student only for support during the practice, the other researcher will fill the "Cardiopulmonary Resuscitation Skills Checklist" by evaluating the cardiopulmonary resuscitation skill of the student. Receives: Device: Haptic |
| High Fidelity Simulator | Experimental | Application in the Simulator Group with High Fidelity: Students will be taught cardiopulmonary resuscitation skills with the CPR Simulator. The student and 2 researchers who will practice will remain in the environment, and the student will also be asked to practice. Receives: Device: High Fidelity Simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sociodemographic Data of the students
The form in which the socio-demographic data of the students such as age and gender are questioned.
Measured: Baseline
Change from Resuscitation Knowledge Test at 3 weeks
Using the books, articles and guides in the literature, 15 multiple-choice questions about CPR were prepared and will be measured with the Resuscitation Knowledge Test. The maximum score to be obtained from this test is 15 and the minimum 0.
Measured: Baseline and 3 week later.
Cardiopulmonary Resuscitation Skills Checklist
While practicing, the student will be evaluated by the observer with a 20-step checklist. Each step will be evaluated as "applied", "partially implemented", "not implemented". The highest score is 100, the lowest score is 0.
Measured: after 1 hour of CPR training (while the student is practicing CPR skill)
Secondary outcomes (1)
Student Satisfaction and Self-Confidence in Learning Scale
This instrument is a 12-item scale. It has 2 sub-dimensions: "Satisfaction with current learning"(5 items) and "Self-Confidence in Learning"(7 items).
Responses are rated on a 5-point Likert scale with values ranging from 1 (strongly disagree) to 5 (strongly agree).
The highest score is 60, the lowest score is 12. It is evaluated that as the score increases, student satisfaction and self-confidence in learning increase.
Measured: within 10 minutes, after the student has practiced the CPR skill
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start2 May 2022 (estimated)
- Primary completion2 Aug 2022 (estimated)
- Study completion2 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Model description
- This study will conducted between April and July 2022 on 60 volunteer students studying in the Department of Nursing Faculty in Turkey. The inclusion criteria were as follows being 18 years old or over, being a fourth year student, be in the classroom on training day. The students included in the study were randomly divided into two groups.The Haptic group will use the Haptic Device with 3D technology and the High Fidelity Simulator group will use High Fidelity CPR Simulator.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlayda Türkoğlu, Saglik Bilimleri Universitesi
- Investigators
- Ayşe Kabuk, PhD, Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343221
- Sponsor's protocol ID
- E-46418926-050.01.04--84464
- Status last verified
- Apr 2022
- First submitted
- 9 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If it is necessary for the ethical issue, investigators can share.
Publications
Panchal AR, Berg KM, Hirsch KG, Kudenchuk PJ, Del Rios M, Cabanas JG, Link MS, Kurz MC, Chan PS, Morley PT, Hazinski MF, Donnino MW. 2019 American Heart Association Focused Update on Advanced Cardiovascular Life Support: Use of Advanced Airways, Vasopressors, and Extracorporeal Cardiopulmonary Resuscitation During Cardiac Arrest: An Update to the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2019 Dec 10;140(24):e881-e894. doi: 10.1161/CIR.0000000000000732. Epub 2019 Nov 14.
PubMed 31722552Su XH, Deng Z, He BW, Liu YQ. Haptic-based virtual reality simulator for lateral ventricle puncture operation. Int J Med Robot. 2020 Dec;16(6):1-10. doi: 10.1002/rcs.2176. Epub 2020 Oct 12.
PubMed 32991775Unver V, Basak T, Watts P, Gaioso V, Moss J, Tastan S, Iyigun E, Tosun N. The reliability and validity of three questionnaires: The Student Satisfaction and Self-Confidence in Learning Scale, Simulation Design Scale, and Educational Practices Questionnaire. Contemp Nurse. 2017 Feb;53(1):60-74. doi: 10.1080/10376178.2017.1282319. Epub 2017 Feb 10.
PubMed 28084900Winship C, Williams B, Boyle MJ. Cardiopulmonary resuscitation before defibrillation in the out-of-hospital setting: a literature review. Emerg Med J. 2012 Oct;29(10):826-9. doi: 10.1136/emermed-2011-200080. Epub 2011 Nov 22.
PubMed 22109533
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Haptic and Highly Fidelity Simulator Use on Knowledge, Skills, Satisfaction and Self-Confidence Levels in Cardiopulmonary Resuscitation Training: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05343221
- Acronym / sponsor ID
- E-46418926-050.01.04--84464
- Conditions
- Nursing Caries, Cardiopulmonary Resuscitation
- Keywords
- Haptic, Highly Fidelity Simulator, Skills, Satisfaction, Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 2 May 2022 (estimated)
- Primary completion
- 2 Aug 2022 (estimated)
- Study completion
- 2 Oct 2022 (estimated)
- First posted
- 25 Apr 2022 (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.
Cardiopulmonary Resuscitation (CPR) is of great importance for nurses who frequently encounter cardiopulmonary arrest in health care institutions and who are within their duties, authorities and responsibilities. Therefore, nurses should have sufficient, up-to-date knowledge and skills about cardiopulmonary resuscitation. Nursing educators should try different training methods on CPR education and ensure that the student has sufficient knowledge and skills before graduation. This study, In order to examine the effects of haptic and highly fidelity simulator use in Cardiopulmonary Resuscitation training in nursing students on their knowledge, skills, satisfaction and self-confidence levels, it was planned to be performed in a randomized controlled type.
Detailed description
This study aim to examine the effects of Haptic and Highly Fidelity Simulator use in Cardiopulmonary Resuscitation training in nursing students on their knowledge, skills, satisfaction and self-confidence levels, it was planned to be performed in a randomized controlled type.
The population of the research will be 4th grade students enrolled in the Faculty of Health Sciences, Faculty of Nursing . The sample of the study will consist of all 4th grade students who meet the sample selection criteria.
Sampling Inclusion Criteria: Individuals over the age of 18, who agreed to participate in the study in written and verbal form, and participated in all phases of the study will be included.
In the randomization part of the study, the students will assigned to the experiment (n=30) and control (n=30) groups according to their number in the class list using the random numbers table.
Data will collect with "Sociodemographic Data Form", "Cardiopulmonary Resuscitation Knowledge Test", "Cardiopulmonary Resuscitation Skills Checklist" and "Student Satisfaction and Confidence in Learning Scale".
Written permission will be obtained from the individuals who volunteered to participate in the study, and "Sociodemographic Data Form" and "Cardiopulmonary Resuscitation Knowledge Test" will be applied to all students.
Cardiopulmonary Resuscitation training will be given theoretically to all students in the classroom environment by an expert academician who has an associate professor in the field of Surgical Nursing. This training will take 1 hour.
The names of all students will be written in alphabetical order, and students will be divided into "Haptic" or "Highly Fidelity Simulator" groups using the random numbers table.
Intervention in Haptic Group: Students will perform Cardiopulmonary resuscitation using 3D Systems Touch Haptic Simulator. During the intervention, there will be 2 researchers and the student who made the application in the room. While one of the researchers will be with the student only for support during the practice, the other researcher will fill the "Cardiopulmonary Resuscitation Skills Checklist" by evaluating the cardiopulmonary resuscitation skill of the student.
Intervention in the High Fidelity Simulator Group: Students will perform Cardiopulmonary resuscitation using High Fidelity CPR Simulator. During the intervention, there will be 2 researchers and the student who made the application in the room. While one of the researchers will be with the student only for support during the practice, the other researcher will fill the "Cardiopulmonary Resuscitation Skills Checklist" by evaluating the cardiopulmonary resuscitation skill of the student. The application of the student will take a total of 10 minutes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will conducted between April and July 2022 on 60 volunteer students studying in the Department of Nursing Faculty in Turkey. The inclusion criteria were as follows being 18 years old or over, being a fourth year student, be in the classroom on training day. The students included in the study were randomly divided into two groups.The Haptic group will use the Haptic Device with 3D technology and the High Fidelity Simulator group will use High Fidelity CPR Simulator.
| Arm | Type | Receives |
|---|---|---|
| Haptic | Experimental | Device: HapticPractice in Haptic Group: Students will be taught cardiopulmonary resuscitation skills with the 3D Systems Touch Haptic Simulator. During the application, there will be 2 researchers and the student who made the application in the room. While one of the researchers will be with the student only for support during the practice, the other researcher will fill the "Cardiopulmonary Resuscitation Skills Checklist" by evaluating the cardiopulmonary resuscitation skill of the student. |
| High Fidelity Simulator | Experimental | Device: High Fidelity SimulatorApplication in the Simulator Group with High Fidelity: Students will be taught cardiopulmonary resuscitation skills with the CPR Simulator. The student and 2 researchers who will practice will remain in the environment, and the student will also be asked to practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Over18 years old
- Being 4nd year student
- Volunteering to take a CPR training
- who agreed to participate in the study in written and verbal form,
- participated in all phases of the study will be included.
Key exclusion criteria (1 listed)
- Not being volunteer to participate in the study
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 |
|---|---|---|
| High Fidelity SimulatorFirst of all, students will be given 1 hour of CPR training. Then they will be asked to apply with the High Fidelity CPR Simulator. This simulator is adult human sized and specialized for CPR practice. It will not be interfered during the application. The student's practice will be evaluated by an observer. The student will evaluate his/her satisfaction after the application is over. | Device | High Fidelity Simulator |
| HapticFirst of all, students will be given 1 hour of CPR training. Then they will be asked to apply with the 3D technology Haptic Device Simulator. This tool has a computer screen and a swing haptic pen. It will not be interfered during the application. The student's practice will be evaluated by an observer. The student will evaluate his/her satisfaction after the application is over. | Device | Haptic |
Primary outcome
Sociodemographic Data of the students
Time frame: Baseline
The form in which the socio-demographic data of the students such as age and gender are questioned.
Change from Resuscitation Knowledge Test at 3 weeks
Time frame: Baseline and 3 week later.
Using the books, articles and guides in the literature, 15 multiple-choice questions about CPR were prepared and will be measured with the Resuscitation Knowledge Test. The maximum score to be obtained from this test is 15 and the minimum 0.
Cardiopulmonary Resuscitation Skills Checklist
Time frame: after 1 hour of CPR training (while the student is practicing CPR skill)
While practicing, the student will be evaluated by the observer with a 20-step checklist. Each step will be evaluated as "applied", "partially implemented", "not implemented". The highest score is 100, the lowest score is 0.
1 secondary outcome
Student Satisfaction and Self-Confidence in Learning Scale
Time frame: within 10 minutes, after the student has practiced the CPR skill
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Results publication: PubMed 31722552Panchal AR, Berg KM, Hirsch KG, Kudenchuk PJ, Del Rios M, Cabanas JG, Link MS, Kurz MC, Chan PS, Morley PT, Hazinski MF, Donnino MW. 2019 American Heart Association Focused Update on Advanced Cardiovascular Life Support: Use of Advanced Airways, Vasopressors, and Extracorporeal Cardiopulmonary Resuscitation During Cardiac Arrest: An Update to the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2019 Dec 10;140(24):e881-e894. doi: 10.1161/CIR.0000000000000732. Epub 2019 Nov 14.
- Results publication: PubMed 32991775Su XH, Deng Z, He BW, Liu YQ. Haptic-based virtual reality simulator for lateral ventricle puncture operation. Int J Med Robot. 2020 Dec;16(6):1-10. doi: 10.1002/rcs.2176. Epub 2020 Oct 12.
- Results publication: PubMed 28084900Unver V, Basak T, Watts P, Gaioso V, Moss J, Tastan S, Iyigun E, Tosun N. The reliability and validity of three questionnaires: The Student Satisfaction and Self-Confidence in Learning Scale, Simulation Design Scale, and Educational Practices Questionnaire. Contemp Nurse. 2017 Feb;53(1):60-74. doi: 10.1080/10376178.2017.1282319. Epub 2017 Feb 10.
- Results publication: PubMed 22109533Winship C, Williams B, Boyle MJ. Cardiopulmonary resuscitation before defibrillation in the out-of-hospital setting: a literature review. Emerg Med J. 2012 Oct;29(10):826-9. doi: 10.1136/emermed-2011-200080. Epub 2011 Nov 22.
- TURKISH CARDIOLOGY ASSOCIATIONLink provided by the sponsor.
- Individual participant dataSharing planned: No. If it is necessary for the ethical issue, investigators can share.
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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.
Ayşe Kabuk, PhD study chair
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 High Fidelity Simulator and Haptic in people with Nursing Caries and Cardiopulmonary 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 5 inclusion and 1 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 25 Apr 2022. 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?
Contact Ayşe Kabuk, PhD (+90546 959 66 16, ayse.kabuk@beun.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sociodemographic Data of the students (time frame: Baseline). The study lists 3 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 NCT05343221, which also lists 4 linked publications.
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 25 Apr 2022.