Simulation-Based Learning Experience in Strengthening Stoma Care Education (SIMESEP)

January 9, 2026 updated by: Nuran Ayşen Pamir Aksoy

Investigation of the Effectiveness of Simulation-Based Learning Experience in Strengthening Stoma Care Education on Patients With Stoma

The goal of this clinical trial is to investigate the effectiveness of simulation-based learning experience in enhancing stoma care education on patients with stoma.

The main hypothesis it aims to test are:

H1: Simulation-based learning experience is effective in reducing stoma patients' concerns about performing stoma care.

H2: Simulation-based learning experience is effective in increasing stoma patients' stoma care skills.

H3: Simulation-based learning experience is effective in increasing stoma patients' perceived self-efficacy regarding stoma care.

Researchers will compare the control and study group to see if the simulation-based learning enhances the patients learning experience.

Participants will be asked to;

  • Answer the questions (demographic data form and anxiety scale)
  • Receive education regarding stoma care (verbal and demonstration)
  • Practice stoma care on their own

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Other
      • Istanbul, Other, Turkey (Türkiye), 34752
        • Acibadem Altunizade Hospital
      • Istanbul, Other, Turkey (Türkiye), 34752
        • Acibadem Atakent Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  1. Age 18 and above
  2. First time having a stoma and having an intestinal stoma,
  3. Communicable, open to cooperation,
  4. Able to speak and understand Turkish,
  5. Individuals who are willing to participate in the research and willing to be interviewed will be included in the research.

Exclusion Criteria

  1. Patients who develop surgical complications in their stoma.
  2. Patients who are unable to perform stoma care due to any complication
  3. Having previously received stoma care training or participated in its implementation for any reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Patients in the control group will receive routine verbal instructions and demonstration education about their stoma care.
Experimental: Study Group
Participants in this group will receive a simulation-based stoma care education.
Behavioral: simulation-based education
Patients will learn how to care for their stomata on a stoma simulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stoma Care Skills Rubric
Time Frame: Post-operative 3rd day
It consists of 23 items that include stoma care process steps. The learner's competence for each process step is scored between 0-2 (0- Insufficient 1- Partially sufficient 2- Sufficient). A minimum of 0 and a maximum of 46 points can be obtained. The total score shows the competence of stoma care skills.
Post-operative 3rd day
Generalized Perceived Self-Efficacy Scale
Time Frame: at the time of enrollement, and Post-operative 3rd day
It consists of 10 items, and each item of the scale is scored between 1 and 4. These are listed as not true (1), somewhat true (2), more true (3), and completely true (4). Minimum of 10 and a maximum of 40 points can be obtained. The higher the score, the higher the individual's perceived self-efficacy.
at the time of enrollement, and Post-operative 3rd day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
State Anxiety Level
Time Frame: at the time of enrollement, and post-operative 3rd day
In the study, the state anxiety scale will be used to determine the anxiety levels of the patients during the application. The State Anxiety Scale (SAS) provides information about what the individual feels at that moment. The State Anxiety Scale is a Likert-type scale consisting of 20 items, rated between 1 (not at all) and 4 (completely).
at the time of enrollement, and post-operative 3rd day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuran Ayşen Pamir Aksoy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

December 27, 2024

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024-17/648

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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