NCT07474181

Brief Summary

The purpose of this study is to comparatively evaluate the effectiveness of two different simulation-based training methods on nursing students' knowledge and skills regarding urinary catheterization in male patients. Accordingly, the effects of hybrid simulation training using a wearable urinary catheter model on students' knowledge level, psychomotor skill acquisition, satisfaction, learning self-confidence, and communication skills will be revealed compared to standard training using traditional partial task instructional models.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Apr 2026Sep 2026

First Submitted

Initial submission to the registry

March 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 16, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 10, 2026

Last Update Submit

March 13, 2026

Conditions

Keywords

urinary catheterizationnursing studentsimulation based learningclinical skills trainingRandomized Controlled Study

Outcome Measures

Primary Outcomes (1)

  • Observation Form for Urinary Catheter Insertion Skills (UCIS Observation Form)

    This is a three-point Likert-type observation checklist developed to objectively evaluate catheter placement skills in male patients. The form consists of 29 critical steps determined through a literature review and based on evidence. Each step is scored as follows: correct application is worth 2 points, partial application is worth 1 point, and failure to complete is worth 0 points. Therefore, the minimum score on the form is 0, and the maximum score is 58. An increase in the score indicates a better performance of the skill.

    During Catheterization Procedure

Secondary Outcomes (5)

  • Participant Information Form (PIF)

    baseline

  • Urinary Catheter Insertion Knowledge Test (UCI-KT)

    baseline/within 10 minutes after urinary catheter insertion

  • Urinary Catheterization Competency Scale (UCCS)

    baseline/within 10 minutes after urinary catheter insertion

  • Student Satisfaction and Self-Confidence in Learning Scale (SSCL)

    within 10 minutes after urinary catheter insertion

  • Healthcare Professionals Communication Skills Scale (HP-CSS)

    within 10 minutes after urinary catheter insertion

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Hybrid Simulation Training

Behavioral: Hybrid Simulation Training

Control Group

ACTIVE COMPARATOR

Partial Task Trainer-Based Simulation

Behavioral: Partial Task Trainer-Based Simulation

Interventions

Control Group (Traditional Method): Immediately following theoretical training, students in the control group will receive skills training in a laboratory setting using a demonstration method with a partial task instructor. The instructor will demonstrate the urinary catheter insertion procedure on a mannequin; then each student will practice individually on the mannequin for 10-15 minutes. Each student will be given a total of three catheter insertion attempts to reinforce the skill. Throughout this process, the instructor will provide necessary corrective feedback. Since this group focuses solely on technical skills without interaction with a real patient, they will be evaluated at the end of the training using a knowledge test, a skills checklist, and a competency scale.

Control Group

Experimental Group (Hybrid Simulation Method): Following theoretical training, students in the experimental group will be divided into small groups of five for a scenario-based hybrid simulation session. In this session, a person playing the role of a simulated patient (e.g., a trained standardized patient or instructor) will have the developed wearable urinary catheter model inserted into its anatomical position. The simulation scenario is designed to reflect a real clinical situation.

Experimental Arm

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Taking the Fundamentals of Nursing course
  • Not having prior clinical experience
  • Not having prior experience with urinary catheterization
  • Not having received prior training in the field of health sciences (e.g., graduate of a health vocational high school, health services vocational college, etc.)
  • Accepts Healthy Volunteers has not been entered.

You may not qualify if:

  • Students who did not complete the research data collection forms
  • Students who did not complete the simulation experiences

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Esra Özer, PhD(c)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Students meeting the study's sampling criteria will be randomly assigned to the experimental group (trained with hybrid simulation) and the control group (trained with partial task instructors). The randomization process will be conducted impartially.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study will compare two groups: an experimental group and a control group. The experimental group will receive hybrid simulation training using a wearable urinary catheter model. The control group will receive low-level simulation training using traditional methods and partial task-teaching models. Both groups will be evaluated with pre- and post-training measurements, and the results between the groups will be compared.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nursing Fundamentals Doctoral Student

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 16, 2026

Study Start

April 16, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03