Effects of Stoma Education on Patients (Stoma)

August 11, 2026 updated by: Nilgün SÖYLEMEZ, Munzur University

Determining the Effects of Stoma Education on Patients' Self-Efficacy, Body Image, and Stoma Adherence

tomas are classified according to the anatomical region in which they are created and the surgical technique used. Stomas that open into the large intestine are called colostomies, those that open into the small intestine are called ileostomies, and the creation of an anastomosis of the ureters to the abdominal wall is called a urostomy. Stomas are commonly used in the treatment of gastrointestinal diseases. Ileostomy and colostomy are the most frequently encountered types of stomas. While colorectal cancer is the primary reason for intestinal stoma creation, inflammatory bowel diseases, penetrating abdominal injuries, congenital anomalies, obstructions due to diverticular disease, ischemic colitis, radiation injury, sigmoid colon volvulus, and fecal incontinence are also among the indications for stoma creation. Despite advances in surgical techniques, complications are commonly seen in individuals with stomas. Incorrect stoma placement, the use of inappropriate bags and adapter systems, and a lack of knowledge and skills among patients and caregivers play a significant role in the development of complications. Depending on these conditions, patients may encounter problems such as edema, bleeding, ischemia, and mucocutaneous dehiscence in the early postoperative period. These complications negatively affect not only physical health but also the individual's social life, psychological state, and overall quality of life. Symptoms such as peristomal skin problems, uncontrolled gas release, fecal incontinence, and pain can hinder participants' adaptation to daily life and lead to social isolation. Nursing care and patient education are of great importance in managing these problems faced by individuals with stomas. The nursing process requires a comprehensive approach extending from the pre-operative period to the post-discharge phase. In this process, individualized education programs addressing fundamental issues such as nutrition, elimination, sexuality, social participation, and privacy should be implemented to improve quality of life, develop self-care skills, and prevent complications. In this context, the investigators have planned this study to determine the effects of the education provided to patients on stoma adaptation, body image, and self-efficacy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Elâzığ, Turkey (Türkiye)
        • Recruiting
        • Fırat University Hospital
    • City Center
      • Tunceli, City Center, Turkey (Türkiye), 62000
        • Recruiting
        • Fırat University Hospital
        • Contact:
        • Sub-Investigator:
          • Beyzanur Kızıloğlu Ağgül, PhD
        • Sub-Investigator:
          • Neziha Karabulut, PhD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults who have undergone colostomy or ileostomy surgery.
  • Willingness to participate voluntarily in the study.
  • Elective surgery patients.
  • No diagnosed psychological disorders.

Exclusion Criteria:

  • Emergency surgery cases.
  • Patients with cognitive impairment or psychiatric disorders preventing participation.
  • Patients unwilling to participate or unable to comply with study follow-ups.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Intervention Group
Teach-Back Education :Nursing intervention Intervention Type: Behavioral Intervention Name: Stoma Care Education Program "No drug or device is used in this intervention."
Other: Teach-Back Education
Stoma care training using the Teach-Back method.
No Intervention: Control Group
Group receiving standard clinical training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Stoma Adjustment
Time Frame: Post-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after discharge
Participant's adjustment to living with a stoma, assessed using a validated stoma adjustment scale at each follow-up. The Stoma Adjustment Scale is a psychosocial assessment tool developed to evaluate the extent to which individuals with stomas have adjusted to their new lives. The scale consists of numerous items that assess an individual's body image, social life, daily activities, ability to manage stoma care, and emotional adjustment, and is commonly used by stoma nurses and researchers. Items are scored using a Likert-type rating scale, and individuals are asked to indicate their level of agreement with each statement. Each item is generally scored from 1 to 6; a score of 1 indicates low adjustment, and a score of 6 indicates high adjustment. The scores of the items on the scale are added together to obtain a total adjustment score. A higher total score indicates better adjustment to the stoma and living with a stoma, while lower scores suggest that the individual may experience
Post-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Image
Time Frame: Post-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after discharge
Participant's perception and satisfaction with body image after stoma formation, measured using a standardized body image questionnaire. The Body Image Scale is a scale used to assess individuals' thoughts and feelings about their own body appearance. The scale consists of statements evaluating a person's level of satisfaction with their body, feelings of discomfort due to their appearance, self-confidence, and feelings about their body in social situations. The scale, comprising 10 items, is scored using a Likert-type scale, with each item rated between 0 and 3 (0: none, 1: somewhat, 2: quite, 3: very much). The scores obtained from the items are added together to obtain a total score between 0 and 30. A higher score indicates that the individual has more discomfort and negative perceptions regarding their body image; a lower score indicates a more positive body image.
Post-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after discharge
Self-Efficacy
Time Frame: Post-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after discharge
Participant's confidence and ability to manage stoma care independently, assessed with a validated self-efficacy. The General Self-Efficacy Scale is a scale used to assess individuals' ability to cope with difficult situations and their belief in their ability to accomplish a specific task. The scale aims to measure an individual's problem-solving skills, willingness to overcome challenges, and self-confidence in achieving their goals. It is commonly used in health and psychology research to determine individuals' self-efficacy levels. The scale consists of 10 items and is scored using a Likert-type scale. Each item is rated on a scale of 1-4 (1: not at all correct, 2: somewhat correct, 3: fairly correct, 4: completely correct). The scores obtained from the items are added together to obtain a total score between 10-40. A high score indicates a high belief in self-efficacy and greater confidence in coping with challenges; a low score indicates a lower perception of self-efficacy.
Post-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after discharge

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Munzur University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026\4-3-8294

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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