Effects of Stoma Education on Patients

NCT07464548 | Recruiting

• 1 other identifier: 2026\4-3-8294
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Colostomy - Stoma; Ileostomy - Stoma; Patient Education; Body Image; Self Efficacy; Adjustment

Outcome Measures

Primary Outcomes (1)

• Stoma Adjustment

  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 Outcomes (2)

• Body Image

  Post-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after discharge

• Self-Efficacy

  Post-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after discharge

Study Arms (2)

Intervention Group

OTHER

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

Control Group

NO INTERVENTION

Group receiving standard clinical training

Interventions

Teach-Back Education OTHER

Stoma care training using the Teach-Back method.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (2)

Fırat University Hospital

Tunceli, City Center, 62000, Turkey (Türkiye)

RECRUITING

Fırat University Hospital

Elâzığ, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Nilgün Söylemez, PhD

CONTACT

+905439790424; nilgunsoylemez@munzur.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will not have information regarding group assignments. Due to the nature of the study, information about the educator who administered the intervention will not be provided. To minimize potential bias, outcome evaluation and data analysis will be performed by individuals who do not have information about group assignments.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Munzur University

Model Details: This study is designed as a randomized, parallel-group interventional trial aiming to enroll at least 100 participants. Participants will be randomly assigned in a 1:1 ratio using Randomizer.org, with allocation concealment ensured through sealed opaque envelopes prepared by an independent researcher. Participants will be assigned to either the intervention group receiving structured stoma care education using the teach-back method or the control group receiving standard clinical education. Due to the nature of the educational intervention, blinding of participants and educators will not be feasible; however, outcome assessors and data analysts will be blinded to group allocation. The first assessment will be conducted on postoperative day 2, followed by evaluations at discharge, and at 1 and 3 months post-discharge. Outcome data will be collected at each time point to assess stoma care knowledge and patient adaptation.

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 11, 2026
• Study Start: March 10, 2026
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): August 10, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)