NCT07559578

Brief Summary

The aim of this study is to examine the effect of colostomy care training based on Jeffries' Simulation Theory on nursing students' knowledge, skills, stress, self-efficacy, readiness, state anxiety, satisfaction, and self-confidence. The study seeks to answer the following hypotheses: H1: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' knowledge levels. H2: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' skill levels. H3: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' stress levels. H4: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' self-efficacy levels. H5: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' preparedness levels. H6: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' levels of situational anxiety. H7: Colostomy care training based on Jeffries' Simulation Theory affects nursing students' levels of learning satisfaction and self-confidence. According to the Colostomy Care Training Booklet prepared by the researchers, all students will receive training on colostomy care procedures. Students in the intervention group will be individually taken to the simulation laboratory for colostomy care applications using moulage on standardized (simulated) patients, and they will be asked to perform the skills acquired during the training. The effectiveness of this intervention will be evaluated by comparing the intervention group with a control group. Participants: Students in the standardized patient simulation group will perform colostomy bag change and colostomy care skills in the simulation laboratory. Students in the low-fidelity simulation group (control group) will perform colostomy bag change and colostomy care skills using a low-fidelity patient model.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

Study Progress57%
Mar 2026Jun 2026

Study Start

First participant enrolled

March 16, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 1, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2026

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 1, 2026

Last Update Submit

April 24, 2026

Conditions

Keywords

Readinesscolostomycareself-sufficiencyself-confidencesimulation

Outcome Measures

Primary Outcomes (7)

  • Colostomy care training based on Jeffries' Simulation Theory provided to nursing students leads to changes in knowledge level scores.

    Colostomy Care Knowledge Assessment Test: The score obtained from the scale ranges from 0 to 100 points. As the score increases, the level of knowledge increases.

    within one week of the simulation exercise

  • The colostomy care training provided to nursing students based on Jeffries' Simulation Theory leads to changes in skill scores.

    Colostomy Care Skills Assessment Form: The score ranges from 0 to 100. As the score increases, so does the level of skill.

    within one week of the simulation exercise

  • The colostomy care training provided to nursing students based on Jeffries' Simulation Theory leads to changes in stress level scores.

    Stress Perception Scale for Nursing Students: The total score on the scale ranges from 0 to 116. A high score on the scale indicates a high level of stress.

    within one week of the simulation exercise

  • The colostomy care training provided to nursing students based on Jeffries' Simulation Theory leads to changes in their self-efficacy scores.

    Self-Efficacy Scale for Clinical Assessment: The lowest possible mean item score on the scale is 0, and the highest is 100. A high score on the scale indicates a high level of self-efficacy regarding clinical performance, whilst a low score indicates a low level of self-efficacy regarding clinical performance.

    within one week of the simulation exercise

  • The colostomy care training provided to nursing students based on Jeffries' Simulation Theory leads to changes in readiness scores.

    Casey-Fink Readiness for Practice Scale: The minimum score on the scale is 15 and the maximum is 60. As the score on the scale increases, students' level of readiness for practice increases.

    within one week of the simulation exercise

  • The colostomy care training provided to nursing students based on Jeffries' Simulation Theory leads to changes in state anxiety scores.

    State-Trait Anxiety Inventory: Scores on the scale range from 20 to 80. A higher score indicates a higher level of anxiety, whilst a lower score indicates a lower level of anxiety.

    within one week of the simulation exercise

  • The colostomy care training provided to nursing students based on Jeffries' Simulation Theory leads to changes in student satisfaction and self-confidence levels in learning.

    Student Satisfaction and Self-Confidence Scale in Learning: The sum of the scale's sub-dimensions does not yield the total scale score; scores are obtained by dividing the sum of the sub-dimension items by the number of items in the relevant sub-dimension. As the score obtained from the scale increases, students' satisfaction with learning and self-confidence also increase.

    within one week of the simulation exercise

Study Arms (2)

Standardized Patient Simulation Group

EXPERIMENTAL
Behavioral: Standardized Patient Simulation Group

Control Group

NO INTERVENTION

Interventions

Students in the intervention group will be taken individually to the simulation laboratory for colostomy care procedures created with mannequins for standard (simulated) patients, and will be asked to apply the skills acquired during training.

Standardized Patient Simulation Group

Eligibility Criteria

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

You may qualify if:

  • Volunteering to participate in the study,
  • Being a fourth-year nursing student,
  • Being enrolled in the HEM-402 course.

You may not qualify if:

  • Being a nurse working in the clinic,
  • Not participating in the training programme,
  • Not wishing to continue with the research, wishing to withdraw from the research at any stage
  • Incomplete or incorrect completion of data collection tools

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafkas University Faculty of Health Sciences

Kars, Central, 36100, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Aybike Merve CİCİ

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 30, 2026

Study Start

March 16, 2026

Primary Completion (Estimated)

May 16, 2026

Study Completion (Estimated)

June 16, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations