The Impact of Education Using a Stoma Care Training Belt

The Impact of Education Using a Stoma Care Training Belt on Care Skills, Adaptation, Anxiety, and Patient Satisfaction in Patients Undergoing Intestinal Stoma Creation:Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stoma Ileostomy; Stoma Colostomy
• Intervention / Treatment: Behavioral: Stoma care education with the Stoma Care Training Belt

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).

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hatice ÖNER CENGİZ, PhD; Phone Number: 05542672908; Email: htcnr8878@gmail.com
• Study Contact Backup: Name: Mehmet YÜKSEKKAYA, PhD; Phone Number: +905326176823; Email: mehmetyk@gmail.com

Study Locations

• Turkey
  • Ankara
    • Altındağ, Ankara, Turkey, 06080
      • Hatice ÖNER CENGİZ
      • Contact: Hatice ÖNER CENGİZ, PhD; Phone Number: 05542672908; Email: htcnr8878@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Stoma care education with the Stoma Care Training Belt; Stoma care education
No Intervention: Control group; Patients in the control group will not undergo any additional intervention beyond routine treatment and care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stoma Care Skills	Stoma Care Skill will be evaluated 4 times in total, using the Stoma Care Skill Rubric, on the day of discharge, and on the 5th, 15th and 30th days after discharge. On the relevant days, patients come to the polyclinic for control. It consists of 23 items that include stoma care process steps. For each process step, the learner's competence is scored between 0-2 (0- Insufficient, 1- Partially adequate, 2- Satisfactory). A minimum of 0 and a maximum of 46 points can be obtained from the key. The total score obtained from the key indicates the adequacy of stoma care skills.	day of discharge and on days 5th, 15th and 30th after discharge
Stoma compliance	Patients' stoma compliance levels will be evaluated 4 times in total, using the Ostomy Compliance Scale-23, on the day of discharge and on the 5th, 15th and 30th days after discharge. On the relevant days, patients come to the polyclinic for control. The total score obtained from the scale varies between 20-80. A high score indicates a high level of anxiety, and a small score indicates a low level of anxiety. The scale score varies between 0-92 points. Higher scores from each scale item indicate increased compliance.	day of discharge and on days 5th, 15th and 30th after discharge
Anxiety	The anxiety levels of the patients will be evaluated 5 times in total, using the State Anxiety Scale, on the day before surgery, on the day of discharge, and on the 5th, 15th and 30th days after discharge. On the relevant days, patients come to the polyclinic for control.The total score obtained from the scale varies between 20-80. A high score indicates a high level of anxiety, and a small score indicates a low level of anxiety.	the day before surgery, day of discharge and on days 5th, 15th and 30th after discharge
Patient Satisfaction	Visual Analog Scale will be used to evaluate patients' satisfaction levels with the training provided with the Stoma Care Training Belt. Accordingly, they will be asked to give a score between 0 (very dissatisfied) and 10 (highest possible satisfaction) regarding their level of satisfaction with the training provided with the Stoma Care Training Belt. As the score increases, the satisfaction level increases.	the day before surgery, day of discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	The development of complications in patients in the Stoma care belt group and control groups will be evaluated in the first postoperative month. When patients come for control on the 30th day, they will be questioned whether any complications have developed.	on day 30th after discharge

Collaborators and Investigators

• Sponsor: Ankara University
• Investigators: Study Chair: Mehmet YÜKSEKKAYA, PhD, Ankara University; Study Chair: İlknur Münevver GÖNENÇ, PhD, Ankara University; Study Chair: Ayten DEMİR, PhD, Ankara University; Study Chair: Ayhan Bülent ERKEK, MD, Ankara University; Study Chair: Şiyar ERSÖZ, MD, Ankara University; Study Chair: Serpil UÇAR, MSc, Ankara University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Anxiety; Patient Satisfaction; Ostomy; Education of patients
• Other Study ID Numbers: HOCengiz

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The researchers do not intend to share research data. But the researchers may only share data from participants for meta-analysis study of randomized controlled trials.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No