NCT06749769

Brief 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

Trial Health

53
Monitor

Trial Health Score

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

Trial recruitment is currently suspended
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
suspended

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 Progress15%
Apr 2026Dec 2026

First Submitted

Initial submission to the registry

December 16, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

December 16, 2024

Last Update Submit

January 9, 2026

Conditions

Stoma

Keywords

stoma carepatient educationsimulationpatient's learning experienceStrengthening patients

Outcome Measures

Primary Outcomes (2)

  • 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.

    Post-operative 3rd day

  • 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.

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

Secondary Outcomes (1)

  • State Anxiety Level

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

Study Arms (2)

Control group

NO INTERVENTION

Patients in the control group will receive routine verbal instructions and demonstration education about their stoma care.

Study Group

EXPERIMENTAL

Participants in this group will receive a simulation-based stoma care education.

Behavioral: simulation-based education

Interventions

simulation-based educationBEHAVIORAL

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

Study Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Acibadem Altunizade Hospital

Istanbul, Other, 34752, Turkey (Türkiye)

Location

Acibadem Atakent Hospital

Istanbul, Other, 34752, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assist. Prof.

Study Record Dates

First Submitted

December 16, 2024

First Posted

December 27, 2024

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations

TU(2)