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

NCT06905925 | Recruiting

• 1 other identifier: CU-SBF-CB-03
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Stoma Colostomy; Colo-rectal Cancer

Keywords

stoma; Colo-rectal cancer; consulting; self-efficacy

Outcome Measures

Primary Outcomes (1)

• Stoma Self-Efficacy Scale (S-SES)

  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

  1 years

Study Arms (2)

no intervention group

NO INTERVENTION

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)."

intervention group

EXPERIMENTAL

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

Other: The group receiving counseling

Interventions

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

intervention group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Adana City Training and Research Hospital

Adana, Yüreğir, 01220, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Cansel Bozer, expert

CONTACT

+905434332624; cansel9815@gmail.com

Ceylan Kişial, expert

CONTACT

+905068010561; cylnksl@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: 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.

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: April 2, 2025
• Study Start: June 23, 2025
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)