The Impact of Education Using a Stoma Care Training Belt

Stoma Ileostomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06391398
• Other study ID #: HOCengiz
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2024
• Source: Ankara University
• Contact: Hatice ÖNER CENGIZ, PhD
• Phone: 05542672908
• Email: htcnr8878[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 170
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stoma Colostomy
• Stoma Ileostomy

Intervention

Behavioral:
• Stoma care education with the Stoma Care Training Belt
Stoma care education

Locations

Country	Name	City	State
Turkey	Hatice ÖNER CENGIZ	Altindag	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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