Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391398
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-25
Brief Title:
The Impact of Education Using a Stoma Care Training Belt
Sponsor:
Ankara University
Organization:
Ankara University
Study Overview
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 CreationRandomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
IntroductionIntestinal 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 ClinicsThe analysis was performed in GPower version 3194It was planned to include a total of 170 patients in the study 85 patients in each groupIn 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 collectedPatients 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 programEthics committee permission was received for the research from Ankara University Ethics Committee Permission was obtained from the institution where the research would be conductedThis research is supported by the Scientific and Technological Research Council of Turkey TUBITAK
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None