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RecruitingNCT07464548StomaUpdated Aug 13, 2026

Effects of Stoma Education on Patients

An interventional study of Teach-Back Education in Colostomy - Stoma, Ileostomy - Stoma and Patient Education, sponsored by Munzur University. Recruiting at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Munzur University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Colostomy - Stoma
  • Ileostomy - Stoma
  • Patient Education
  • Body Image
  • Self Efficacy
  • Adjustment
03

In context

Lead sponsor

Munzur University is the lead sponsor of 10 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • No intervention
    Control Group

    Group receiving standard clinical training

Interventions

  • OtherTeach-Back Education

    Stoma care training using the Teach-Back method.

06

What researchers measure

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

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

Secondary outcomes

  1. Body Image

    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.

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

  2. Self-Efficacy

    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.

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

07

Study locations

2 of 2 sites recruiting
  • Fırat University Hospital
    Tunceli, City Center 62000, Turkey (Türkiye)
    Recruiting
    • Nilgün Söylemez, PhD · Contactnilgunsoylemez@munzur.edu.tr · +905439790424
    • Beyzanur Kızıloğlu Ağgül, PhD · Sub investigator
    • Neziha Karabulut, PhD · Sub investigator
  • Fırat University Hospital
    Elâzığ, Turkey (Türkiye)
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2026 (actual). Primary completion is estimated for Nov 2026, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 3, 2026
First posted
Mar 11, 2026
StartActual
Mar 10, 2026
Primary completionEst.
Nov 10, 2026
CompletionEst.
Nov 10, 2026
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07464548
Lead sponsor
Munzur University
Responsible party
Nilgün SÖYLEMEZ (Munzur University, Munzur University) — Principal investigator
First posted
Mar 11, 2026
Start date
Mar 10, 2026
Primary completion
Nov 10, 2026 (estimated)
Completion
Nov 10, 2026 (estimated)
Last update
Aug 13, 2026

Study contacts

Nilgün Söylemez, PhD
Contact
nilgunsoylemez@munzur.edu.tr
+905439790424

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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