NCT05837377

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2024

Completed
Last Updated

February 2, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

April 11, 2023

Last Update Submit

February 1, 2024

Conditions

Keywords

cognitive load theoryDrug Administrationcompetencysimulation

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    The assessment will be conducted one week after the objective structured skill examination. The change in these time intervals will be assessed.

Study Arms (2)

Control- standard medication education

EXPERIMENTAL

The control group will receive a traditional medication administration proficiency training program.

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.

Other: Experiment- cognitive load theory based on medication education

Interventions

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.

Control- standard medication education

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.

Experiment- cognitive load theory based on medication education

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Inability to complete any stage of the study,
  • Failure to complete data collection forms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem Unıversity

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 33640776BACKGROUND
  • 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.

    PMID: 26154251BACKGROUND
  • 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.

    PMID: 30153925BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND

Study Officials

  • Hilal Yıldız Çelik, Phd student

    Acibadem University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hilal Yıldız Çelik, Phd Student

CONTACT

Esra Uğur, associate professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2023

First Posted

May 1, 2023

Study Start

September 1, 2024

Primary Completion

November 4, 2024

Study Completion

December 5, 2024

Last Updated

February 2, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations