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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-23

Study Completion Date

2026-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Laughter Therapy on Self-Esteem and Quality of Life in Patients With Stoma

NCT05601024

Stoma Colostomy Stoma Ileostomy

COMPLETED NA

The Effect of Patient Education and Rehabilitation on Quality of Life in Patients With Permanent Stomas

NCT01154725

Colostomy

COMPLETED NA

Effect of Stoma Prehabilitation on Stoma Patients

NCT04692610

Stoma Anxiety Depression +1 more

COMPLETED NA

Effect of Video Training on Patients' Self-Efficacy After Colorectal Surgery

NCT07078656

Colorectal Cancer

NOT_YET_RECRUITING NA

Effectiveness of Remote Self-care Education for Ostomy Patients

NCT05796544

Ostomy

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stoma Colostomy Colo-rectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Written consent will be obtained from the patients in both the intervention and control groups one day before or on the day of surgery. A "Personal Information Form" will be completed through face-to-face interviews with patients who agree to participate in the study. This process is expected to take approximately 5 minutes.

Patients in the experimental group will receive pre-operative stoma care education from the researcher. This training is expected to last about 15 minutes. After the training, a brochure will be provided to the patients that they can use if they need further information. During the training process, patients will be informed that the researcher will contact them by phone after discharge during the 1st, 2nd, 3rd, and 4th weeks. 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. In addition, at the end of the 2nd week, if there are no

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

no intervention group

No intervention will be performed by the researcher for the patients in the control group. During this process, standard care education will be provided by clinical nurses, and phone follow-up and counseling protocols will not be applied. Patients in the control group will also be contacted by phone by the researcher during the 2nd and 4th weeks after discharge to complete the "Stoma Self-Efficacy Scale (S-SES)."

Group Type NO_INTERVENTION

No interventions assigned to this group

intervention group

Here is the English translation of the provided text:

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 relativ

Group Type EXPERIMENTAL

The group receiving counseling

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The group receiving counseling

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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,

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No