NCT07732049

Brief Summary

Detailed Description This randomized controlled trial aims to compare the effectiveness of three educational approaches in improving nursing students' knowledge, clinical skill performance, and self-efficacy regarding sterile urine specimen collection from an indwelling urinary catheter. The study will be conducted during the Spring semester of the 2025-2026 academic year in the Nursing Skills Laboratory at Maltepe University. The study population will consist of first-year nursing students enrolled in the Fundamentals of Nursing course. Students aged 18 years or older who voluntarily agree to participate will be eligible. Students who have previously received training or have experience in collecting sterile urine specimens from an indwelling urinary catheter will be excluded from the study. Phase 1: Selection and Training of Peer Educators Peer educators will be selected from volunteer fourth-year nursing students who have previous mentoring experience with first-year students and a grade point average above 3.0. Before the intervention, peer educators will receive standardized training from the principal investigator using Peyton's Four-Step Teaching Approach. The training will focus on sterile urine specimen collection from an indwelling urinary catheter and will be based on a validated procedural checklist with excellent reliability. During the training, peer educators will complete all four stages of Peyton's model, including demonstration, deconstruction, comprehension, and performance with structured feedback to ensure standardized instruction throughout the study. Phase 2: Theoretical Education, Baseline Assessment, and Randomization All eligible first-year nursing students will receive a four-hour theoretical lecture delivered by the course instructor before practical training. The theoretical content will include urinary system anatomy and physiology, urinary elimination and assessment, urinary catheterization, sterile urine specimen collection from an indwelling urinary catheter, and prevention of catheter-associated urinary tract infections. Following the theoretical session, participants will complete baseline assessments consisting of a Demographic Information Form, a Knowledge Test, and the Student Self-Efficacy Scale. Participants will then be randomly assigned in a 1:1:1 ratio to one of three study groups: Peyton Four-Step Teaching delivered by the course instructor. Peyton Four-Step Teaching delivered by trained peer educators. Traditional demonstration-based instruction delivered by the course instructor (control group). Randomization will be performed by an independent researcher who is not involved in participant recruitment, intervention delivery, or outcome assessment. A computer-generated block randomization sequence (block size = 6) created using Randomizer.org will be used to ensure balanced allocation among groups. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. The researcher responsible for outcome assessment will remain blinded to group allocation throughout the study. Phase 3: Practical Skills Training Following randomization, students will receive practical training according to their assigned group. The two intervention groups will be taught using Peyton's Four-Step Teaching Approach by either the course instructor or trained peer educators. This approach consists of demonstration, deconstruction with step-by-step explanation, comprehension through learner-guided instruction, and independent performance with structured feedback. The control group will receive conventional demonstration-based instruction in which the instructor demonstrates and explains the procedure before students independently perform the skill. All practical sessions will be conducted individually in the nursing skills laboratory using simulation manikins. Student performance during training will follow the same validated procedural checklist to ensure standardization across groups. Phase 4: Post-Intervention Assessment After completing the practical training, participants will complete the Knowledge Test, Student Self-Efficacy Scale, and a Student Satisfaction Questionnaire developed by the researchers. Clinical skill performance will be evaluated by a blinded assessor using the validated procedural checklist employed throughout the intervention. Statistical analyses will be performed by an independent researcher who is not involved in the intervention or assessment process. This study is designed to determine whether Peyton's Four-Step Teaching Approach, delivered either by faculty members or trained peer educators, provides superior educational outcomes compared with conventional demonstration-based instruction. Participation in the study is entirely voluntary. The assessments are conducted solely for research purposes and will not contribute to students' course grades, academic achievement, or formal performance evaluation.

Trial Health

63
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Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Sep 2026

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 21, 2026

Last Update Submit

July 27, 2026

Conditions

Keywords

Peyton ApproachPeer Assisted learningUndergraduate Nursing StudentsClinical SkillsÜriner Catheterizasyon

Outcome Measures

Primary Outcomes (1)

  • Skill performance in sterile urine specimen collection from an indwelling urinary catheter

    Skill performance will be evaluated using the Urine Specimen Collection from an Indwelling Urinary Catheter Skills Checklist. Higher scores indicate better procedural skill performance.

    Immediately after completion of the training intervention

Secondary Outcomes (3)

  • Knowledge level regarding sterile urine specimen collection from an indwelling urinary catheter

    Before the intervention and immediately after completion of the training intervention

  • Self-efficacy

    Before the intervention and immediately after completion of the training intervention

  • Student satisfaction with the educational intervention

    Immediately after completion of the training intervention

Study Arms (3)

Faculty-Led Peyton Model

EXPERIMENTAL

Participants assigned to this arm will receive practical training in sterile urine specimen collection from an indwelling urinary catheter using the Peyton Four-Step Teaching Model delivered by the course instructor. The intervention consists of demonstration, deconstruction, comprehension, and independent performance with structured feedback. Training will be conducted individually in the nursing skills laboratory using simulation manikins and a standardized procedural checklist.

Behavioral: Peyton Four-Step Teaching Model

Peer-Led Peyton Model

EXPERIMENTAL

Participants assigned to this arm will receive practical training in sterile urine specimen collection from an indwelling urinary catheter using the Peyton Four-Step Teaching Model delivered by trained peer educators. Peer educators will be fourth-year nursing students who have successfully completed the relevant course and received standardized training from the course instructor before the intervention. The training will follow the four sequential steps of the Peyton model: demonstration, deconstruction, comprehension, and independent performance with structured feedback. All training sessions will be conducted individually in the nursing skills laboratory using simulation manikins and a standardized procedural checklist.

Behavioral: Peyton Four-Step Teaching Model

Traditional Demonstration (Control)

ACTIVE COMPARATOR

Participants assigned to this arm will receive practical training in sterile urine specimen collection from an indwelling urinary catheter using the traditional demonstration-based teaching method delivered by the course instructor. The instructor will explain and demonstrate the procedure according to the standardized skills checklist, after which participants will practice the procedure individually under supervision and receive feedback. All training sessions will be conducted in the nursing skills laboratory using simulation manikins and the same standardized procedural checklist used in the intervention groups to ensure consistency in educational content and outcome assessment.

Behavioral: Traditional Demonstration-Based Teaching

Interventions

Participants will receive practical training in sterile urine specimen collection from an indwelling urinary catheter using the Peyton Four-Step Teaching Model. The intervention consists of four sequential steps: demonstration, deconstruction, comprehension, and independent performance with structured feedback. Depending on study group allocation, the training will be delivered either by the course instructor or by trained peer educators. All training sessions will be conducted individually in the nursing skills laboratory using simulation manikins and a standardized procedural checklist to ensure consistency of the educational content and skill assessment

Faculty-Led Peyton ModelPeer-Led Peyton Model

Participants will receive practical training in sterile urine specimen collection from an indwelling urinary catheter using the traditional demonstration-based teaching method. The course instructor will explain and demonstrate the procedure according to the standardized procedural checklist. Following the demonstration, participants will practice the procedure individually under supervision and receive structured feedback. All training sessions will be conducted in the nursing skills laboratory using simulation manikins and the same standardized procedural checklist used in the intervention groups.

Traditional Demonstration (Control)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maltepe University, Faculity of Nursing

Istanbul, 38457, Turkey (Türkiye)

Location

Study Officials

  • Ebru Çalışkan, pHd

    Maltepe University, Faculty of Nursing

    PRINCIPAL INVESTIGATOR
  • Tuğba Bozdemir, PhD

    Maltepe University, Faculty of Nursing

    STUDY DIRECTOR
  • Adife Ahsen ÇETİN

    Maltepe University, Faculty of Nursing

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Outcome assessment and statistical analyses will be performed by researchers who are blinded to group allocation. Participants and instructors will not be blinded due to the nature of the educational intervention.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1:1 ratio to three parallel groups using block randomization with allocation concealment. Two intervention groups will receive Peyton Model-based training delivered by either a faculty member or a trained peer educator, while the control group will receive traditional demonstration-based instruction. Outcome assessment will be performed by a blinded assessor.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 28, 2026

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

February 1, 2027

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) collected during this study will not be shared because the study involves educational data collected from undergraduate students, and no data-sharing plan has been established.

Locations