Nursing EducationNCT07732088
Gagné Instructional Model
A study testing Traditional Demonstration-Based Instruction, Peer-Led Gagné-Based Training and Faculty-Led Gagné-Based Training in people with Nursing Education and Clinical Skills Training, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nursing Education, Clinical Skills Training
- What is being tested?
- Traditional Demonstration-Based Instruction, Peer-Led Gagné-Based Training and Faculty-Led Gagné-Based Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2026to 15 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Maltepe University, Faculity of Nursing
Istanbul, 34857
Ebru Çalışkan, PhD, 505 2641381, ebrucaliskan@maltepe.edu.tr
About this study
Official title: 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.
Read more
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.
- Conditions
- Nursing Education, Clinical Skills Training
- Being tested
- Traditional Demonstration-Based Instruction, Peer-Led Gagné-Based Training, Faculty-Led Gagné-Based Training
- Keywords
- Nursing Education, Gagné's Nine Events of Instruction, Clinical Skills Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Demonstration-Based InstructionBehavioural
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.
Peer-Led Gagné-Based TrainingBehavioural
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.
Faculty-Led Gagné-Based TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Demonstration-Based Instruction | Active comparator | 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. Receives: Behavioral: Traditional Demonstration-Based Instruction |
| Peer-Led Gagné-Based Training | Experimental | 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. Receives: Behavioral: Peer-Led Gagné-Based Training |
| Faculty-Led Gagné-Based Training | Experimental | 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. Receives: Behavioral: Faculty-Led Gagné-Based Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the educational intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing EducationStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel study arms using computer-generated simple randomization. The three groups include: (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. All groups will receive the same educational content, training duration, instructional materials, and simulation laboratory environment. The only differences between groups will be the instructional method and the individual delivering the training. Outcome assessors will be blinded to group allocation.
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Caliskan, Maltepe University
- Investigators
- Ebru Çalışkan, Principal investigator, Maltepe University, Faculty of NursingTuğba Bozdemir, Study director, Maltepe University, Faculty of NursingAdife Ahsen Çetin, Study director, Maltepe University, Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732088
- Sponsor's protocol ID
- 2026/06-14
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07732088
- Acronym / sponsor ID
- 2026/06-14
- Conditions
- Nursing Education, Clinical Skills Training
- Keywords
- Nursing Education, Gagné's Nine Events of Instruction, Clinical Skills Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 28 Jul 2026 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel study arms using computer-generated simple randomization. The three groups include: (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. All groups will receive the same educational content, training duration, instructional materials, and simulation laboratory environment. The only differences between groups will be the instructional method and the individual delivering the training. Outcome assessors will be blinded to group allocation.
| Arm | Type | Receives |
|---|---|---|
| Traditional Demonstration-Based Instruction | Active comparator | Behavioral: Traditional Demonstration-Based InstructionParticipants 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. |
| Peer-Led Gagné-Based Training | Experimental | Behavioral: Peer-Led Gagné-Based TrainingParticipants 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. |
| Faculty-Led Gagné-Based Training | Experimental | Behavioral: Faculty-Led Gagné-Based TrainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Traditional Demonstration-Based InstructionParticipants 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. | Behavioural | Traditional Demonstration-Based Instruction |
| Peer-Led Gagné-Based TrainingParticipants 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. | Behavioural | Peer-Led Gagné-Based Training |
| Faculty-Led Gagné-Based TrainingParticipants 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. | Behavioural | Faculty-Led Gagné-Based Training |
Primary outcome
Urinary Catheterization Skill Performance
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: 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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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.
Ebru Çalışkan principal investigator
Maltepe University, Faculty of Nursing
Tuğba Bozdemir study director
Maltepe University, Faculty of Nursing
Adife Ahsen Çetin study director
Maltepe University, Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Demonstration-Based Instruction, Peer-Led Gagné-Based Training and Faculty-Led Gagné-Based Training in people with Nursing Education and Clinical Skills Training, run by Maltepe 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 4 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: opening soon, as of the sponsor's last update on 6 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ebru Çalışkan, PhD (+90 5052641381, ebrucaliskan@maltepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary Catheterization Skill Performance (time frame: Immediately after the educational intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2026.