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SuspendedNCT06749769SIMESEPUpdated Jan 12, 2026

Simulation-Based Learning Experience in Strengthening Stoma Care Education

An interventional study of simulation-based education in Stoma, sponsored by Nuran Ayşen Pamir Aksoy. Suspended at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-12.

Sponsored by Nuran Ayşen Pamir Aksoy · Not applicable, Interventional, and Other

Why this study was suspended
Due to changes in the clinical research team. The surgeon responsible for performing the study-related procedures has left the study hospital. The research team is currently seeking an appropriately qualified investigator to resume the study.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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
02

Conditions studied

  • Stoma

Keywords

  • stoma care
  • patient education
  • simulation
  • patient's learning experience
  • Strengthening patients
03

In context

Lead sponsor

Nuran Ayşen Pamir Aksoy is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
70 participants (estimated)

Study arms

  • 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

Interventions

  • Behavioralsimulation-based education

    Patients will learn how to care for their stomata on a stoma simulator

06

What researchers measure

Primary outcomes

  1. Stoma Care Skills Rubric

    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.

    Time frame: Post-operative 3rd day

  2. Generalized Perceived Self-Efficacy Scale

    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.

    Time frame: at the time of enrollement, and Post-operative 3rd day

Secondary outcomes

  1. State Anxiety Level

    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).

    Time frame: at the time of enrollement, and post-operative 3rd day

07

Study locations

2 sites
  • Acibadem Altunizade Hospital
    Istanbul, Other 34752, Turkey (Türkiye)
  • Acibadem Atakent Hospital
    Istanbul, Other 34752, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06749769
Lead sponsor
Nuran Ayşen Pamir Aksoy
Responsible party
Nuran Ayşen Pamir Aksoy (Assist. Prof., Acibadem University) — Sponsor-investigator
First posted
Dec 27, 2024
Start date
Apr 2026 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Jan 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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