Nursing StudentNCT05837377
Drug Administration Competency of Nursing Students
A study testing Experiment- cognitive load theory based on medication education in people with Nursing Student and Simulation, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to examine the effect of a simulation-based education program designed based on cognitive load theory on the development of medication administration competency of nursing students. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nursing Student, Simulation, Cognitive Load
- What is being tested?
- Experiment- cognitive load theory based on medication education
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 5 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to complete any stage of the study,
- Failure to complete data collection forms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Simulation-Based Training Program Designed Based on Cognitive Load Theory on Drug Administration Competency
The purpose of this study is to examine the effect of a simulation-based education program designed based on cognitive load theory on the development of medication administration competency of nursing students.
Read the 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.
- Conditions
- Nursing Student, Simulation, Cognitive Load, Competence
- Being tested
- Control- standard medication education, Experiment- cognitive load theory based on medication education
- Keywords
- cognitive load theory, Drug Administration, competency, simulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control- standard medication educationOther
Common Procedure:
- "Student Information and Consent Form will be obtained from the students.
For the control group
- Theoretical training in drug administration skills is provided.
- Skill training: Skill training on intramuscular and subcutaneous injection and intravenous medication administration using task trainers in the simulation laboratory.
- After the skill evaluation phase, a safe drug administration scenario will be applied.
Experiment- cognitive load theory based on medication educationOther
For the experiment group
- Theoretical training will be provided based on the results of both the knowledge test and the self-efficacy test, and will be designed according to the principles of cognitive load theory.
- Skills training: includes the necessary skill applications for students with task trainers and a virtual simulation designed according to the cognitive load theory for these skills.
- After the skill evaluation phase, a safe drug administration scenario will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Control- standard medication education | Experimental | The control group will receive a traditional medication administration proficiency training program. Receives: Other: Control- standard medication education |
| Experiment- cognitive load theory based on medication education | Experimental | The experiment group will receive a cognitive load theory-based medication administration training program. Receives: Other: Experiment- cognitive load theory based on medication education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in medication administration knowledge level
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.
Measured: 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
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.
Measured: 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
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.
Measured: The assessment will be conducted one week after the objective structured skill examination. The change in these time intervals will be assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Sep 2024 (estimated)
- Primary completion4 Nov 2024 (estimated)
- Study completion5 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nursing StudentStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hilal Yıldız Çelik, Phd student, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837377
- Sponsor's protocol ID
- 14.02.2022-03/17
- Status last verified
- Feb 2024
- First submitted
- 11 Apr 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33640776Fraser 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.
PubMed 26154251McMullan 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.
PubMed 30153925Sweller, 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 at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation-Based Training Program Designed Based on Cognitive Load Theory on Drug Administration Competency
- ClinicalTrials.gov ID
- NCT05837377
- Acronym / sponsor ID
- 14.02.2022-03/17
- Conditions
- Nursing Student, Simulation, Cognitive Load, Competence
- Keywords
- cognitive load theory, Drug Administration, competency, simulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 4 Nov 2024 (estimated)
- Study completion
- 5 Dec 2024 (estimated)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effect of a simulation-based education program designed based on cognitive load theory on the development of medication administration competency of nursing students.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control- standard medication education | Experimental | Other: Control- standard medication educationThe control group will receive a traditional medication administration proficiency training program. |
| Experiment- cognitive load theory based on medication education | Experimental | Other: Experiment- cognitive load theory based on medication educationThe experiment group will receive a cognitive load theory-based medication administration training program. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Inability to complete any stage of the study,
- Failure to complete data collection forms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control- standard medication educationCommon Procedure: - "Student Information and Consent Form will be obtained from the students. For the control group * Theoretical training in drug administration skills is provided. * Skill training: Skill training on intramuscular and subcutaneous injection and intravenous medication administration using task trainers in the simulation laboratory. * After the skill evaluation phase, a safe drug administration scenario will be applied. | Other | Control- standard medication education |
| Experiment- cognitive load theory based on medication educationFor the experiment group * Theoretical training will be provided based on the results of both the knowledge test and the self-efficacy test, and will be designed according to the principles of cognitive load theory. * Skills training: includes the necessary skill applications for students with task trainers and a virtual simulation designed according to the cognitive load theory for these skills. * After the skill evaluation phase, a safe drug administration scenario will be applied. | Other | Experiment- cognitive load theory based on medication education |
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Background: PubMed 33640776Rogers 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.
- Background: PubMed 26154251Fraser 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.
- Background: PubMed 30153925McMullan 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.
- BackgroundSweller, 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
- BackgroundJosephsen, 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilal Yıldız Çelik, Phd student principal investigator
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experiment- cognitive load theory based on medication education in people with Nursing Student and Simulation, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hilal Yıldız Çelik, Phd Student (02165004172, hilal.yildiz@acibadem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05837377, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.