- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05343221
The Effect of Haptic and Highly Fidelity Simulator in Cardiopulmonary Resuscitation Training
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ayşe Kabuk, PhD
- Phone Number: +90546 959 66 16
- Email: ayse.kabuk@beun.edu.tr
Study Contact Backup
- Name: Ayşe Kabuk, PhD
- Phone Number: +90546 959 66 16
- Email: ayseyalili@gmail.com
Study Locations
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Uskudar
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Istanbul, Uskudar, Turkey
- University of Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Not being volunteer to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Haptic
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.
|
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.
|
|
Experimental: High Fidelity Simulator
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Baseline
|
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Change from Resuscitation Knowledge Test at 3 weeks
Time Frame: Baseline and 3 week later.
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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.
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Baseline and 3 week later.
|
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Cardiopulmonary Resuscitation Skills Checklist
Time Frame: after 1 hour of CPR training (while the student is practicing CPR skill)
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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.
|
after 1 hour of CPR training (while the student is practicing CPR skill)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Student Satisfaction and Self-Confidence in Learning Scale
Time Frame: within 10 minutes, after the student has practiced the CPR skill
|
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. |
within 10 minutes, after the student has practiced the CPR skill
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ayşe Kabuk, PhD, Saglik Bilimleri Universitesi
Publications and helpful links
General 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.
- Su 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.
- Unver 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.
- Winship 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- E-46418926-050.01.04--84464
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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