Clinical trials

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.

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.

This research aims to determine the effect of hammock position and nesting practices on the comfort level and physiological parameters of preterm babies.

This randomized controlled trial aims to evaluate the effect of tonsillectomy diet education on postoperative bleeding and pain in children undergoing adenotonsillectomy. Seventy-six pediatric patients will be randomly assigned to either an intervention group, which will receive specific diet education prior to surgery, or a control group receiving standard care. Bleeding and pain will be assessed at 4, 8, and 24 hours, and on the 7th day after surgery using a specialized follow-up form and the Wong-Baker Faces Pain Rating Scale. The study hypothesizes that diet education will reduce postoperative bleeding and pain, improving recovery and quality of life in children.