Clinical trial NCT06905925: The Effect of the Training Program Given to Permanent Colostomy Patients on Self-efficacy
Official title: The Effect of the Training Program Given to Permanent Colostomy Patients on Self-efficacy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stoma Colostomy
Colo-rectal Cancer
Keywords: stoma
Colo-rectal cancer
consulting
self-efficacy
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: To eliminate selection bias and ensure balance in the number of patients between groups, randomization will be performed in the study. Randomization will be generated by an independent researcher not involved in the study using a computer tool (https://www.randomizer.org/), and X envelopes will be numbered from 1 to X. Inside the envelopes, cards will indicate whether the participant belongs to the intervention or control group based on the randomization table. Participants who are admitted to the clinic and consent to participate in the study by signing the consent form will be assigned to the intervention or control group based on the envelope number corresponding to their admission order. Once the researcher obtains written consent from the participants, they will open the envelope to determine which group the participant belongs to. This process ensures that randomization and group assignment are concealed, thus controlling for selection bias in the study.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The effect of the training program given to permanent colostomy patients on self-efficacy
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Adana City Training and Research Hospital
state: Yüreğir
Study officials:
References: