Clinical trial NCT06391398: The Impact of Education Using a Stoma Care Training Belt
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stoma Colostomy
Stoma Ileostomy
Keywords: Ostomy
Education of patients
Anxiety
Patient Satisfaction
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel-group, randomized controlled trial will be conducted to assess the effect of the Stoma Care Training Belt on patients' stoma care skills, adaptation, anxiety, and satisfaction. A total of 170 patients, with 85 in the intervention group and 85 in the control group, will be included. All patients in the study will receive routine stoma care education as part of their standard treatment and care. In addition to routine treatment and care, patients in the intervention group will receive education with the Stoma Care Training Belt during the preoperative period.
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Stoma Care Skills
timeFrame: day of discharge and on days 5th, 15th and 30th after discharge
measure: Stoma compliance
timeFrame: day of discharge and on days 5th, 15th and 30th after discharge
measure: Anxiety
timeFrame: the day before surgery, day of discharge and on days 5th, 15th and 30th after discharge
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: the day before surgery, day of discharge
Other outcomes:
Locations:
city: Altındağ
country: Turkey
facility: Hatice ÖNER CENGİZ
state: Ankara
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
affiliation: Ankara University
name: Mehmet YÜKSEKKAYA, PhD
role: STUDY_CHAIR
affiliation: Ankara University
name: İlknur Münevver GÖNENÇ, PhD
role: STUDY_CHAIR
affiliation: Ankara University
name: Ayten DEMİR, PhD
role: STUDY_CHAIR
affiliation: Ankara University
name: Ayhan Bülent ERKEK, MD
role: STUDY_CHAIR
affiliation: Ankara University
name: Şiyar ERSÖZ, MD
role: STUDY_CHAIR
affiliation: Ankara University
name: Serpil UÇAR, MSc
role: STUDY_CHAIR
References: