- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05837377
Drug Administration Competency of Nursing Students
The Effect of Simulation-Based Training Program Designed Based on Cognitive Load Theory on Drug Administration Competency
Study Overview
Status
Conditions
Detailed Description
The study was designed according to a pre-post test control group randomized controlled experimental design. During the research procedure, the medication administration competency training program will be implemented to the groups by using two different methods. In the training program will be applied to the experiment group will designed to be considered of the intrinsic, extraneous, and germane loads described in Cognitive Load Theory.
For randomization, a list of students who will be agreed to participate in the study, will be created and assigned serial numbers by a faculty other than researcher. The control and experiment groups will be formed by randomly assigning these serial numbers using a computer program (www.random.org). To prevent repeated student evaluations and potential bias, students will be tracked using their serial numbers during the data collection process.
The control group will receive the medication administration competency training program using the conventional education method.
A cognitive load theory-based medication administration competency training program will be applied to the experiment group of students. The cognitive load theory explains the amount of mental effort that is required to perform mental processes and is loaded onto memory resources. This theory helps to make learning more effective by reducing students' cognitive load, taking into account factors such as the complexity of learning materials and their presentation format. In this context, the content structuring of the training program will be determined according to the students' knowledge levels and cognitive loads that will be identified before the training program. The training program consists of theoretical education, skill training, medication administration competency virtual simulations, and scenario applications. The students' knowledge levels, cognitive loads, and medication administration competency self-assessments will be evaluated before and after the theoretical education. Skill levels will be evaluated by using structured observation tools during the skill training, and cognitive loads and clinical decision-making competency levels will be evaluated at the end of the scenario.
In data collection:
- To evaluate the knowledge levels of the control and experiment group students regarding medication administration before and after the training, the Medication Administration Knowledge Test will be used.
- To assess the psychomotor skills of students regarding medication administration, Objective Structured Clinical Examination (OSCE) checklists for medication dosage calculation and administration via intramuscular, subcutaneous, and intravenous routes will be used.
- The Medication Administration Competence Self-Assessment Form will be applied to students to assess herself on medication administration competence and its subcomponents.
- The Cognitive Load Scale will be used to determine how much mental effort the student exerts while performing tasks related to medication administration.
- The Simulation Self-Reported Cognitive Load Measurement Tool will be used to determine the cognitive, extraneous, and germane loads of the control and experiment group students after the scenario application.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hilal Yıldız Çelik, Phd Student
- Phone Number: 02165004172
- Email: hilal.yildiz@acibadem.edu.tr
Study Contact Backup
- Name: Esra Uğur, associate professor
- Phone Number: 02165004164
- Email: esra.ugur@acibadem.edu.tr
Study Locations
-
-
-
İstanbul, Turkey
- Acıbadem Unıversity
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- To be over 18 years old,
- Minimum 18 years old,
- To be a third or fourth-year nursing undergraduate student,
- To volunteer to participate in the research.
Exclusion Criteria:
- Inability to complete any stage of the study,
- Failure to complete data collection forms.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Control- standard medication education
The control group will receive a traditional medication administration proficiency training program.
|
Common Procedure: - "Student Information and Consent Form will be obtained from the students. For the control group
|
|
Experimental: Experiment- cognitive load theory based on medication education
The experiment group will receive a cognitive load theory-based medication administration training program.
|
For the experiment group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in medication administration knowledge level
Time Frame: The Medication Administration Knowledge Test will be administered before the training and again one week after the training. The change in these time intervals will be assessed.
|
Medication Administration Knowledge Test scores of students in a simulation-based training programme designed according to cognitive load theory are higher than those of students in the standard training programme.
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The Medication Administration Knowledge Test will be administered before the training and again one week after the training. The change in these time intervals will be assessed.
|
|
Comparison of medication administration skill performances
Time Frame: It will be conducted one week after the skill training. The change in these time intervals will be assessed.
|
The Objective Structured Clinical Examination (OSCE) scores of students in a simulation-based training programme designed according to cognitive load theory are higher than those of students in the standard training programme.
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It will be conducted one week after the skill training. The change in these time intervals will be assessed.
|
|
Comparison of Clinical Decision Making Skill Level
Time Frame: The assessment will be conducted one week after the objective structured skill examination. The change in these time intervals will be assessed.
|
Students' scores on the control list for safe drug administration scenarios in a simulation-based training programme designed according to cognitive load theory are higher than those of students in the standard training programme.
|
The assessment will be conducted one week after the objective structured skill examination. The change in these time intervals will be assessed.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hilal Yıldız Çelik, Phd student, Acibadem University
Publications and helpful links
General Publications
- Rogers BA, Franklin AE. Cognitive load experienced by nurses in simulation-based learning experiences: An integrative review. Nurse Educ Today. 2021 Apr;99:104815. doi: 10.1016/j.nedt.2021.104815. Epub 2021 Feb 20.
- Fraser KL, Ayres P, Sweller J. Cognitive Load Theory for the Design of Medical Simulations. Simul Healthc. 2015 Oct;10(5):295-307. doi: 10.1097/SIH.0000000000000097.
- McMullan M. Evaluation of a medication calculation mobile app using a cognitive load instructional design. Int J Med Inform. 2018 Oct;118:72-77. doi: 10.1016/j.ijmedinf.2018.07.005. Epub 2018 Jul 24.
- Sweller, J. (2020). Cognitive load theory and educational technology. Educational Technology Research and Development, 68(1), 1-16. Doi: https://doi.org/10.1007/s11423-019-09701-3
- Josephsen, J. (2018). Cognitive load measurement, worked-out modeling, and simulation. Clinical Simulation in Nursing, 23, 10-15. doi:https://doi.org/10.1016/j.ecns.2018.07.004
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- 14.02.2022-03/17
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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