- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05784675
Impact of Mobile Phone Application Use on Adult BLS (MOBI-CPR)
Impact of Serious Smartphone-based Game Use on Adult Performance of Basic Life Support Skills
Study Overview
Status
Intervention / Treatment
Detailed Description
The trial design will be randomized, controlled, cross-over study. Data will be collected between March and May 2023 at the Faculty of health science, University of Maribor. The consentience of nursing students will be collected. The Faculty of health science, University of Maribor already give permission for conducting this study. The goal will be to have around 100 nursing students in the study.
In the study a serious smartphone game called MOBI-CPR will be used. The MOBI-CPR game will be available at https://mobicpr.si/. The MOBI-CPR game will be install on the smartphone and will be used at home by nursing students with a goal to obtain adult basic life support knowledge and skills.
Before each nursing student will get MOBI-CPR game for home usage we will 1) measure acute stress, and 2) assess adult basic life support knowledge and skills.
For measuring acute stress the Empatica E4 watch will be used. Measuring will be perform in a quiet room without disruptions. When measuring acute stress each nursing student will be coloring the mandalas circles. Level of acute stress measure by Empatica E4 watch (1-5 is non stress area, and 6-10 is stress area).
For the knowledge part the online modified questionnaire (available in: https://www.1ka.si/d/en) the multiple choice questions will be used, and for the skills part the Resusci Anne QCPR QCPR manikin and Defibtech Trainer AED will be used. Each nursing student will be given the scenarios to read before the start of the assistance to the victim of a sudden cardiac arrest. The investigators will use a modified checklist to assess students' performance in adult basic life support.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nino Fijačko, Msc
- Phone Number: +38623004764
- Email: nino.fijacko@um.si
Study Contact Backup
- Name: Pavel Skok, MD
- Phone Number: +38623212871
- Email: pavel.skok@ukc-mb.si
Study Locations
-
-
-
Maribor, Slovenia, 2000
- Recruiting
- University of Maribor Faculty of health sciences
-
Contact:
- Nino Fijacko
- Phone Number: +38623004764
- Email: nino.fijacko@um.si
-
Contact:
- Gregor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Nursing students over eighteen years old
- Without training in adult basic life support or within the past six mounts
- Physically able to perform CPR
- Willingness to perform rescue breathing on a manikin
- A completed and signed consent form
Exclusion Criteria:
- Nursing student younger than 18 years old
- Undergone training on adult basic life support within the past six mounts
- Physically not able to perform CPR
- Do not want to perform rescue breathing on a manikin
- Do not want to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MOBI-CPR
Participants use MOBI-CPR game at home environment.
|
Participants use MOBI-CPR game at home environment.
|
No Intervention: No MOBI-CPR
Participants do not use MOBI-CPR game at home environment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge
Time Frame: 2 weeks after baseline intervention
|
Total score from the questionnaire (50 questions with multiple open answer, each right answer is 1 point) on the theoretical adult basic life support knowledge.
If the assessment score is over 70%, it indicates that the nursing student is successful.
|
2 weeks after baseline intervention
|
Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge
Time Frame: 4 weeks after baseline intervention
|
Total score from the questionnaire (50 questions with multiple open answer, each right answer is 1 point) on the theoretical adult basic life support knowledge.
If the assessment score is over 70%, it indicates that the nursing student is successful.
|
4 weeks after baseline intervention
|
Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge
Time Frame: 6 mounts after baseline intervention
|
Total score from the questionnaire (50 questions with multiple open answer, each right answer is 1 point) on the theoretical adult basic life support knowledge.
If the assessment score is over 70%, it indicates that the nursing student is successful.
|
6 mounts after baseline intervention
|
Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge
Time Frame: 1 year after baseline intervention
|
Total score from the questionnaire (50 questions with multiple open answer, each right answer is 1 point) on the theoretical adult basic life support knowledge.
If the assessment score is over 70%, it indicates that the nursing student is successful.
|
1 year after baseline intervention
|
Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge
Time Frame: 3 years after baseline intervention
|
Total score from the questionnaire (50 questions with multiple open answer, each right answer is 1 point) on the theoretical adult basic life support knowledge.
If the assessment score is over 70%, it indicates that the nursing student is successful.
|
3 years after baseline intervention
|
Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills
Time Frame: 2 weeks after baseline intervention
|
Total score from the checklist (20 steps with correct or not correct assess of the adult basic life support, each right assess is 1 point) on the practical adult basic life support skills.
If the assessment score is over 70%, it indicates that the nursing student is successful.
|
2 weeks after baseline intervention
|
Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills
Time Frame: 4 weeks after baseline intervention
|
Total score from the checklist (20 steps with correct or not correct assess of the adult basic life support, each right assess is 1 point) on the practical adult basic life support skills.
If the assessment score is over 70%, it indicates that the nursing student is successful.
|
4 weeks after baseline intervention
|
Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills
Time Frame: 6 mounts after baseline intervention
|
Total score from the checklist (20 steps with correct or not correct assess of the adult basic life support, each right assess is 1 point) on the practical adult basic life support skills.
If the assessment score is over 70%, it indicates that the nursing student is successful.
|
6 mounts after baseline intervention
|
Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills
Time Frame: 1 year after baseline intervention
|
Total score from the checklist (20 steps with correct or not correct assess of the adult basic life support, each right assess is 1 point) on the practical adult basic life support skills.
If the assessment score is over 70%, it indicates that the nursing student is successful.
|
1 year after baseline intervention
|
Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills
Time Frame: 3 years after baseline intervention
|
Total score from the checklist (20 steps with correct or not correct assess of the adult basic life support, each right assess is 1 point) on the practical adult basic life support skills.
If the assessment score is over 70%, it indicates that the nursing student is successful.
|
3 years after baseline intervention
|
Impact of the use of the MOBI-CPR game on the level of acute stress
Time Frame: 2 weeks after baseline intervention
|
Level of acute stress measure by Empatica E4 watch (1-5 is non stress area, and 6-10 is stress area).
|
2 weeks after baseline intervention
|
Impact of the use of the MOBI-CPR game on the level of acute stress
Time Frame: 4 weeks after baseline intervention
|
Level of acute stress measure by Empatica E4 watch (1-5 is non stress area, and 6-10 is stress area).
|
4 weeks after baseline intervention
|
Impact of the use of the MOBI-CPR game on the level of acute stress
Time Frame: 6 mounts after baseline intervention
|
Level of acute stress measure by Empatica E4 watch (1-5 is non stress area, and 6-10 is stress area).
|
6 mounts after baseline intervention
|
Impact of the use of the MOBI-CPR game on the level of acute stress
Time Frame: 1 year after baseline intervention
|
Level of acute stress measure by Empatica E4 watch (1-5 is non stress area, and 6-10 is stress area).
|
1 year after baseline intervention
|
Impact of the use of the MOBI-CPR game on the level of acute stress
Time Frame: 3 years after baseline intervention
|
Level of acute stress measure by Empatica E4 watch (1-5 is non stress area, and 6-10 is stress area).
|
3 years after baseline intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nino Fijačko, Msc, University of Maribor, Faculty of Health Sciences
Publications and helpful links
General Publications
- Hernandez-Padilla J, Suthers F, Fernandez-Sola C, Granero-Molina J. Development and psychometric assessment of the Basic Resuscitation Skills Self-Efficacy Scale. Eur J Cardiovasc Nurs. 2016 Apr;15(3):e10-8. doi: 10.1177/1474515114562130. Epub 2014 Nov 24.
- Papalexopoulou K, Chalkias A, Dontas I, Pliatsika P, Giannakakos C, Papapanagiotou P, Aggelina A, Moumouris T, Papadopoulos G, Xanthos T. Education and age affect skill acquisition and retention in lay rescuers after a European Resuscitation Council CPR/AED course. Heart Lung. 2014 Jan-Feb;43(1):66-71. doi: 10.1016/j.hrtlng.2013.09.008. Epub 2013 Oct 11.
Study record dates
Study Major Dates
Study Start (Actual)
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOBI-CPR game trial
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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