- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06169839
The Effect of Different Simulation Methods Used in Adult Basic Life Support Training
December 5, 2023 updated by: Ayşenur YETİK ARAS, Ankara University
The Effect of Different Simulation Methods Used in Adult Basic Life Support Training on Knowledge, Skills, Self-Efficacy, and Satisfaction in Layperson First Aider
Aim: The aim of this study, evaluating the effects of different simulation methods (virtual reality assisted simulation, high reality simulation, low reality simulation) used in Adult Basic Life Support (BLS) training on knowledge, skills, self-efficacy and satisfaction characteristics in Layperson First Aider
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
- Behavioral: Providing BLS and AED trainings given by the Ministry of Health with Low Realism Simulation.
- Behavioral: Providing BLS and AED trainings given by the Ministry of Health with High Reality Simulation
- Behavioral: Providing BLS and AED trainings given by the Ministry of Health with Virtual Reality
Detailed Description
Aim: The aim of this study, evaluating the effects of different simulation methods (virtual reality assisted simulation, high reality simulation, low reality simulation) used in Adult Basic Life Support (BLS) training on knowledge, skills, self-efficacy and satisfaction characteristics in Layperson First Aider Material and Method: The population of the research consists of participants in the TYD and OED (Automatic External Defibrillator) training with participation certificate to be given to public institutions by the Ministry of Health in Ankara between 01.01.2024 and 10.03.2024.
Power analysis was performed using the G*Power (v3.1.9)
program to determine the sample size.
The medium effect size (d=0.45)
used in a previous similar study was calculated at the end of the study as.
Type I error α=0.05,
Study power 1-β (β=Type II error probability) 0.8, and 3 groups were calculated by means of a statistical power analysis.
The estimated total sample size of all intervention groups was 51.
Considering that there may be losses during the study process, it was decided to recruit 20 people in each group.This study was designed as a prospective randomized controlled trial.
As data collection tools: Introductory Characteristics Form, General Self-Efficacy Scale (GAS), Basic Life Support Knowledge Level Evaluation Form, Basic Life Support Application Skill Form, Basic Life Support Self-Efficacy Questionnaire and Basic Life Support Education Satisfaction Questionnaire were used.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Altindağ
-
Ankara, Altindağ, Turkey, 06340
- Ankara University, Nursing Faculty
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Voluntarily agreeing to participate in the research
- Being between the ages of 18-65
- Having applied for Basic life support and Automatic external defibrillator training with a participation certificate issued by the Ministry of Health.
- Being a Ministry of Health personnel.
Exclusion Criteria:
- Refusal to participate in the research
- Becoming a health professional
- Receiving previously authorized basic first aid training.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Skill training with Low Realism Simulation
the theoretical part of the TYD and OED training with Participation Certificate, the curriculum of which is created by the Ministry of Health, will be explained (by the Researcher).
(2 hours) Skill training with Low Realism Simulation (1 hour) Basic CPR Manikin (classical training provided by the Ministry of Health),
|
the theoretical part of the Certificate of Participation TYD and OED training, the curriculum of which is created by the Ministry of Health, will be explained (by the researcher) (2 hours).
Skill training with Low Realism Simulation (1 hour) Basic CPR Manikin (classical training given by the Ministry of Health),
|
Experimental: Skills training with High Reality Simulation
the theoretical part of the TYD and OED training with Participation Certificate, the curriculum of which is created by the Ministry of Health, will be explained (by the Researcher).
(2 hours) Skills training with High Reality Simulation (1 hour) SimMan® 3G (Laerdal medical)
|
the theoretical part of the Certificate of Participation TYD and OED training, the curriculum of which is created by the Ministry of Health, will be explained (by the researcher) (2 hours).
Skill training with High Reality Simulation (1 hour) SimMan® 3G (Laerdal medical)
|
Experimental: Skill training will be given with Virtual Reality Application Supported Simulation
the theoretical part of the TYD and OED training with Participation Certificate, the curriculum of which is created by the Ministry of Health, will be explained (by the Researcher).
(2 hours) Skill training will be given with Virtual Reality Application Supported Simulation (1 hour) and application training will be given with 3D MedSim.
|
the theoretical part of the Certificate of Participation TYD and OED training, the curriculum of which is created by the Ministry of Health, will be explained (by the researcher) (2 hours).
Skill training with Virtual Reality Application Supported Simulation (1 hour) Application training will be given with 3D MedSim.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Basic Life Support (BLS) Knowledge Level Evaluation
Time Frame: 3 months
|
20 multiple-choice questionnaires aimed at measuring the BLS knowledge level prepared by the researcher in line with the relevant literature.
It is evaluated on the basis of the highest 20 and the lowest 0 points.
Getting high scores from the questions indicates a high level of BLS knowledge.
Application process; pre-test, post-training post-test and 3-month post-test.
|
3 months
|
Basic Life Support Application Skill
Time Frame: 3 months
|
Basic Life Support Application Skill Form: BLS skill evaluation form used by the Ministry of Health.
It consists of 11 questions.
The highest score is 20 and the lowest is 0. Getting high scores from the questions indicates a high level of BLS skill level.
Application process; post-training test and 3-month post-test.
|
3 months
|
Basic Life Support Self-Efficacy
Time Frame: 3 months
|
It was created to measure self-efficacy in emergency CPR, based on the General Self-Efficacy Scale. 4 items are 7-point Likert type.
Getting high scores on the items indicates a high level of general self-efficacy.
Application process; post-training test and 3-month post-test.
|
3 months
|
Basic Life Support Training Satisfaction
Time Frame: 3 days
|
A choice will be made between 0 and 10. "0" indicates I am not satisfied at all, "10" indicates I am very satisfied.
Application process; post-training testing.
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General Self-Efficacy Scale (GÖYS)
Time Frame: 3 days
|
The number of items is 10.
The scale was prepared as a 4-point Likert type.
Getting high scores on the items indicates a high level of general self-efficacy.
Application process; pre-training test.
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2023
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
November 24, 2023
First Submitted That Met QC Criteria
December 5, 2023
First Posted (Estimated)
December 14, 2023
Study Record Updates
Last Update Posted (Estimated)
December 14, 2023
Last Update Submitted That Met QC Criteria
December 5, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- AU-N-AYA-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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