- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07732088
Gagné Instructional Model
The Effect of Peer- and Instructor-Led Training Based on the Gagné Instructional Model on Urinary Catheterization Skill and Self-Efficacy: A Three-Arm Randomized Controlled Trial
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.
Studie Overzicht
Toestand
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Ebru Çalışkan, PhD
- Telefoonnummer: +90 5052641381
- E-mail: ebrucaliskan@maltepe.edu.tr
Studie Contact Back-up
- Naam: Tuğba Bozdemir, PhD
- Telefoonnummer: +90 5520978860
- E-mail: tugbabozdemir@maltepe.edu.tr
Studie Locaties
-
-
-
Istanbul, Turkije (Türkiye), 34857
- Maltepe University, Faculity of Nursing
-
Contact:
- Ebru Çalışkan, PhD
- Telefoonnummer: 505 2641381
- E-mail: ebrucaliskan@maltepe.edu.tr
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- First-year undergraduate nursing students enrolled in the Fundamentals of Nursing course at Maltepe University Faculty of Nursing
- Aged 18 years or older- No previous theoretical or practical training in urinary catheterization
- No prior clinical experience performing urinary catheterization
- Able to understand the study procedures and provide written informed consent
Exclusion Criteria:
- Previous education or clinical experience in urinary catheterization
- Failure to attend the assigned educational intervention
- Failure to complete the study assessments or outcome measurements
- Withdrawal of informed consent at any stage of the study
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Traditional Demonstration-Based Instruction
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.
|
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.
|
|
Experimenteel: Peer-Led Gagné-Based Training
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.
|
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.
|
|
Experimenteel: Faculty-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.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Urinary Catheterization Skill Performance
Tijdsspanne: Immediately after the educational intervention
|
Urinary catheterization skill performance will be assessed using a standardized urinary catheterization skills checklist completed by blinded assessors in the simulation laboratory.
|
Immediately after the educational intervention
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Ebru Çalışkan, Maltepe University, Faculty of Nursing
- Studie directeur: Tuğba Bozdemir, Maltepe University, Faculty of Nursing
- Studie directeur: Adife Ahsen ÇETİN, Maltepe University, Faculty of Nursing
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 2026/06-14
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .