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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05784675
Other study ID # MOBI-CPR game trial
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 16, 2023
Est. completion date August 31, 2023

Study information

Verified date May 2023
Source University Maribor
Contact Nino Fijacko, Msc
Phone +38623004764
Email nino.fijacko@um.si
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to investigate whether a serious smartphone game (called MOBI-CPR game) used in the home environment has an impact on the retention of adult basic life support knowledge and skills.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 31, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Device:
MOBI-CPR game
Participants use MOBI-CPR game at home environment.

Locations

Country Name City State
Slovenia University of Maribor Faculty of health sciences Maribor

Sponsors (1)

Lead Sponsor Collaborator
Nino Fijacko

Country where clinical trial is conducted

Slovenia, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge 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
Primary Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge 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
Primary Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge 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
Primary Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge 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
Primary Impact of the use of the MOBI-CPR game on the total score of theoretical adult basic life support knowledge 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
Primary Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills 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
Primary Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills 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
Primary Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills 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
Primary Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills 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
Primary Impact of the use of the MOBI-CPR game on the total score of practical adult basic life support skills 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
Primary Impact of the use of the MOBI-CPR game on the level of acute stress 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
Primary Impact of the use of the MOBI-CPR game on the level of acute stress 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
Primary Impact of the use of the MOBI-CPR game on the level of acute stress 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
Primary Impact of the use of the MOBI-CPR game on the level of acute stress 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
Primary Impact of the use of the MOBI-CPR game on the level of acute stress 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
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