- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07464548
Effects of Stoma Education on Patients (Stoma)
April 15, 2026 updated by: Nilgun Soylemez, Ataturk 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
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
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 Contact
- Name: Nilgün Söylemez, PhD
- Phone Number: +905439790424
- Email: nilgunsoylemez@munzur.edu.tr
Study Locations
-
-
-
Elâzığ, Turkey (Türkiye)
- Recruiting
- Fırat University Hospital
-
-
City Center
-
Tunceli, City Center, Turkey (Türkiye), 62000
- Recruiting
- Fırat University Hospital
-
Contact:
- Nilgün Söylemez, PhD
- Phone Number: +905439790424
- Email: nilgunsoylemez@munzur.edu.tr
-
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
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 |
Intervention / Treatment |
|---|---|
|
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."
|
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
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
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
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)
March 10, 2026
Primary Completion (Estimated)
July 10, 2026
Study Completion (Estimated)
August 10, 2026
Study Registration Dates
First Submitted
March 3, 2026
First Submitted That Met QC Criteria
March 6, 2026
First Posted (Actual)
March 11, 2026
Study Record Updates
Last Update Posted (Actual)
April 17, 2026
Last Update Submitted That Met QC Criteria
April 15, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Other Study ID 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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