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NCT Number: NCT06905925

The Effect of the Training Program Given to Permanent Colostomy Patients on Self-efficacy

The planned research aims to evaluate the impact of a training program on self-efficacy in patients with permanent colostomies. It highlights the importance of holistic patient education in preventing complications and improving adaptation to stomas, which can positively affect patients' quality of life and self-efficacy.

Recruiting

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Stomas can be either temporary or permanent. Stomas can cause physical issues such as uncontrolled gas output, bad odor, leakage, and local skin irritation, as well as psychological and social problems such as sexual dysfunction, changes in body image, decreased self-esteem, interpersonal relationship issues, depression, anxiety, loneliness, fear, and shame. These problems can reduce individuals' self-care abilities, negatively affect daily living activities, increase their vulnerability to stoma/peristomal complications, and further delay the closure of temporary stomas. Regardless of the type of stoma, all of these issues negatively impact patients' self-efficacy.

Many of these problems and potential complications after stoma formation are preventable. Patient education provided through a holistic approach covering pre-operative, post-operative, and home care and follow-up is of great importance in preventing complications and improving patients' adaptation to the stoma. However, a review of the literature reveals that stoma-related education programs typically focus on assessing quality of life and similar factors. Some of the studies reviewed include educational content on pre-operative patient preparation and post-operative care, while others focus only on post-operative complication management. However, high-evidence guidelines, such as Enhanced Recovery After Surgery (ERAS) protocols, emphasize that the first step toward a successful surgical process should be patient education delivered through a holistic approach covering the entire surgical process.

Therefore, the planned research will be conducted to evaluate the effect of a training program provided to patients with permanent colostomies on self-efficacy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Patients scheduled for permanent colostomy following colorectal surgery,
  • Aged 18 years and older,
  • Conscious, with orientation to person, time, and place,
  • Able to speak Turkish,
  • Without auditory or visual impairments,
  • Using a phone, were included in the study. Exclusion Criteria:• Patients who could not be contacted during the study period, or those who developed post-operative complications (such as stenosis, necrosis, ileus, dermatitis, parastomal herniation, etc.) were excluded from the sample.

Treatment and study plan

The group receiving counseling

Other

Patients in the experimental group will receive pre-operative stoma care education from the researcher. This training is expected to last approximately 15 minutes. After the training, a brochure will be provided to the patients, which they can use if they need additional information. During the training process, patients will be informed that the researcher will contact them by phone during the 1st, 2nd, 3rd, and 4th weeks after discharge. During these calls, patients will be asked weekly (during weeks 1, 2, 3, and 4) about the color, odor, texture of the wound area, the function of the colostomy, and any complications. Additionally, at the end of the 2nd week, if there are no issues around the wound or sutures, patients will be called to the hospital for suture removal and dressing changes. In other weeks, dietary habits and the condition of the wound will also be inquired. During this four-week period, patients or their relatives will be informed that they can contact the researcher

Primary outcomes

  1. Stoma Self-Efficacy Scale (S-SES)

    Time frame: 1 years

    The scale was developed to examine the self-efficacy status of patients with stoma. Its validity and reliability in Turkish were conducted by Karaçay et al. The scale consists of 22 items and two subscales. The scale is a 5-point Kickert type, rated from 1 to 5, where 1: definitely do not trust and 5: definitely trust. Items 1-13 of the scale examine Stoma Care Self-Efficacy (S-SES Care), and items 14-22 examine Social Life Self-Efficacy (S-SES Social). The lowest score that can be obtained from the scale is 22, while the highest score is 110. A higher score indicates higher self-efficacy. In the Turkish validity-reliability study of the scale, the Croncbach alpha coefficient was found to be 0.95

Study contacts

Contact information is provided by the study sponsor or research team.

Cansel Bozer, expert

CONTACT

[email protected]

+905434332624

Ceylan Kişial, expert

CONTACT

[email protected]

+905068010561

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 2, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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