An interventional study of Traditional Demonstration-Based Instruction and Peer-Led Gagné-Based Training in Nursing Education and Clinical Skills Training, sponsored by Maltepe University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Maltepe University · Not applicable, Interventional, and Other
Urinary catheterization is one of the essential clinical skills that undergraduate nursing students are expected to acquire during their early professional education. Competent performance of this procedure requires not only theoretical knowledge but also psychomotor competence and confidence. Identifying effective teaching strategies for urinary catheterization is therefore important for improving nursing education and promoting patient safety. Although peer-assisted learning has been widely implemented in nursing education, evidence comparing structured instructional models delivered by peer educators and faculty instructors remains limited.
The purpose of this study is to evaluate the effects of peer-led training based on the Gagné Instructional Model on nursing students' urinary catheterization knowledge, skill performance, and self-efficacy. The effectiveness of peer-led Gagné-based training will be compared with faculty-led Gagné-based training and traditional demonstration-based instruction.
This study is designed as a single-center, three-arm, parallel-group randomized controlled trial. The study population will consist of first-year undergraduate nursing students enrolled in the Fundamentals of Nursing course at Maltepe University Faculty of Nursing during the 2025-2026 academic year. Eligible students who are 18 years of age or older, have not previously received formal theoretical or practical education on urinary catheterization, have no prior urinary catheterization experience in clinical practice, and provide written informed consent will be invited to participate. Participants who have previously received urinary catheterization training or clinical experience, fail to attend the educational sessions, or do not complete the study assessments will be excluded.
Sample size was calculated using G*Power 3.1 for repeated-measures ANOVA (within-between interaction). Based on an effect size of 0.25, a significance level of 0.05, statistical power of 95%, three study groups, and two measurement time points, the minimum required sample size was calculated as 66 participants. To compensate for potential attrition, 81 participants (27 per group) will be recruited.
Participants will be randomly assigned in a 1:1:1 ratio using computer-generated simple randomization to one of three study groups: (1) traditional demonstration-based instruction delivered by a faculty instructor, (2) peer-led training based on the Gagné Instructional Model, and (3) faculty-led training based on the Gagné Instructional Model. The educational content, teaching materials, training duration, simulation laboratory environment, and learning objectives will be identical across all groups. The only difference between groups will be the instructional approach and the individual delivering the training. Before the intervention, peer educators will receive standardized preparation regarding the Gagné Instructional Model to ensure consistency of instruction.
Data collection will be conducted using a pretest-posttest design. Before the intervention, participants will complete a knowledge test, a self-efficacy scale, and an affective self-assessment form. Following completion of the educational intervention, the knowledge test and self-efficacy scale will be repeated, and urinary catheterization skill performance will be evaluated using a standardized skills checklist.
Because participants and instructors cannot be blinded in educational intervention studies, assessor blinding will be implemented. Outcome assessors responsible for evaluating knowledge, self-efficacy, and urinary catheterization skill performance will remain unaware of participants' group allocation. Group assignments will also remain coded during statistical analyses to minimize assessment bias.
The findings of this study are expected to provide evidence regarding the effectiveness of Gagné model-based peer education in undergraduate nursing education and contribute to the development of evidence-based instructional strategies for teaching psychomotor nursing skills.
Maltepe University is the lead sponsor of 67 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive urinary catheterization training through the traditional demonstration-based teaching method delivered by a faculty instructor. The educational content, duration, instructional materials, and simulation environment are identical to those used in the other study groups.
Behavioral: Traditional Demonstration-Based Instruction
Participants receive urinary catheterization training based on the Gagné Instructional Model delivered by trained peer educators. The educational content, duration, instructional materials, and simulation environment are identical to those used in the other study groups.
Behavioral: Peer-Led Gagné-Based Training
Participants receive urinary catheterization training based on the Gagné Instructional Model delivered by a faculty instructor. The educational content, duration, instructional materials, and simulation environment are identical to those used in the other study groups.
Behavioral: Faculty-Led Gagné-Based Training
Participants receive urinary catheterization training using the traditional demonstration-based teaching method delivered by a faculty instructor. The instructor demonstrates the procedure according to the standard nursing skills protocol, followed by supervised student practice. The educational content, training duration, instructional materials, and simulation laboratory environment are identical to those used in the other study groups; only the instructional method differs.
Participants receive urinary catheterization training based on the Gagné Instructional Model delivered by trained peer educators. Peer educators implement the nine instructional events of the Gagné model using standardized educational materials and simulation-based practice. The educational content, training duration, instructional materials, and simulation laboratory environment are identical to those used in the other study groups; only the instructor and instructional approach differ.
Participants receive urinary catheterization training based on the Gagné Instructional Model delivered by a faculty instructor. The instructor implements the nine instructional events of the Gagné model using standardized educational materials and simulation-based practice. The educational content, training duration, instructional materials, and simulation laboratory environment are identical to those used in the other study groups; only the instructor and instructional approach differ.
Urinary Catheterization Skill Performance
Urinary catheterization skill performance will be assessed using a standardized urinary catheterization skills checklist completed by blinded assessors in the simulation laboratory.
Time frame: Immediately after the educational intervention
Plan to share: No — ndividual participant data will not be shared because the study involves identifiable educational assessment data collected from students, and data sharing is not covered by the participants' informed consent or the ethics committee approval.
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Maltepe University