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Effects of Stoma Education on Patients

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07464548
Acronym
Stoma
Enrollment
100
Registered
2026-03-11
Start date
2026-03-10
Completion date
2026-11-10
Last updated
2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

Stoma care training using the Teach-Back method.

Sponsors

Munzur University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Stoma AdjustmentPost-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after dischargeParticipant'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

Secondary

MeasureTime frameDescription
Body ImagePost-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after dischargeParticipant'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.
Self-EfficacyPost-surgery day 2, discharge day (days 7-10), 1 month after discharge, 3 months after dischargeParticipant'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.

Countries

Turkey (Türkiye)

Contacts

CONTACTNilgün Söylemez, PhD
nilgunsoylemez@munzur.edu.tr+905439790424

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026