The Impact of Education Using a Stoma Care Training Belt

NCT ID: NCT06391398

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-04-22

Brief Summary

Intestinal stoma is a surgical procedure performed to create an artificial opening in the intestine. To improve the quality of life of individuals with stoma, it is essential to address physiological and psychosocial issues and ensure adaptation to the stoma. Patient education on stoma care during the preoperative period may facilitate stoma adaptation. The aim of this study is to evaluate the impact of the education provided to patients undergoing intestinal stoma creation using a Stoma Care Training Belt on stoma care skills, adaptation, anxiety, and satisfaction.

Detailed Description

Introduction:Intestinal stoma is a surgical procedure performed to create an artificial opening in the intestine. To improve the quality of life of individuals with stoma, it is essential to address physiological and psychosocial issues and ensure adaptation to the stoma. Patient education on stoma care during the preoperative period may facilitate stoma adaptation. The aim of this study is to evaluate the impact of the education provided to patients undergoing intestinal stoma creation using a Stoma Care Training Belt on stoma care skills, adaptation, anxiety, and satisfaction. This study will be conducted as a parallel group, randomized controlled study at Ankara University Health Practice and Research Hospitals Ibn-i Sina Research and Practice Hospital and Ankara University Health Practice and Research Hospitals Cebeci Research and Practice Hospital General Surgery Clinics.The analysis was performed in G*Power version 3.1.9.4.It was planned to include a total of 170 patients in the study, 85 patients in each group.In order to ensure similarity between groups; Simple randomization will be used to assign the women in the sample group to the experimental and control groups. Data, sociodemographic and medical data form, State Anxiety Scale, Stoma Care Skill Rubric, Ostomy Adaptation Scale-23 and Visual Analogue Scale (VAS)-Patient satisfaction level will be collected.Patients will be evaluated 5 times in total: on the day of discharge, and on the 5th, 15th and 30th days after discharge. The data will be evaluated in a computer environment with appropriate statistical methods using the Statistical Package for Social Sciences 25 (SPSS) for Windows statistical package program.Ethics committee permission was received for the research from Ankara University Ethics Committee. Permission was obtained from the institution where the research would be conducted.This research is supported by the Scientific and Technological Research Council of Turkey (TUBITAK).

Conditions

Stoma Colostomy; Stoma Ileostomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Stoma care belt group

In addition to routine treatment and care, patients in the intervention stoma care belt group will receive education with the Stoma Care Training Belt during the preoperative period.

Group Type: EXPERIMENTAL

Stoma care education with the Stoma Care Training Belt

Intervention Type: BEHAVIORAL

Stoma care education

Control group

Patients in the control group will not undergo any additional intervention beyond routine treatment and care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Stoma care education with the Stoma Care Training Belt

Stoma care education

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Intestinal stoma (colostomy or ileostomy) opened for the first time,
• Those aged 18 and over, Able to speak and understand Turkish,
• Conscious, oriented and cooperative,
• Does not have a diagnosed psychiatric or psychological disease,
• There is no obstacle to stoma care, Those who have no previous stoma knowledge or training.

Exclusion Criteria

• Those who do not agree to participate in the study,
• Refuses to perform stoma care in the postoperative period,
• Leaving the job voluntarily, Those who died during the work process,
• Referred from the relevant hospital during the treatment process,
• Any postoperative complications (bleeding, infection, fistula, etc.) develop,
• Data collection forms could not be completed,
• Patients who cannot be reached will be excluded.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara University

OTHER

Sponsor Role: lead

Responsible Party

Hatice ÖNER CENGİZ

Assist. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet YÜKSEKKAYA, PhD

Role: STUDY_CHAIR

Ankara University

İlknur Münevver GÖNENÇ, PhD

Role: STUDY_CHAIR

Ankara University

Ayten DEMİR, PhD

Role: STUDY_CHAIR

Ankara University

Ayhan Bülent ERKEK, MD

Role: STUDY_CHAIR

Ankara University

Şiyar ERSÖZ, MD

Role: STUDY_CHAIR

Ankara University

Serpil UÇAR, MSc

Role: STUDY_CHAIR

Ankara University

Locations

Hatice ÖNER CENGİZ

Altındağ, Ankara, Turkey (Türkiye)

Ankara University

Ankara, Ankara, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HOCengiz

Identifier Type: -

Identifier Source: org_study_id