Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT06979102
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-31
First Post:
2025-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of Real Patient Interactive Stoma Care Management Teaching
Sponsor:
Hacettepe University
Organization:
Study Overview
Official Title:
The Effect of Real Patient Interactive Stoma Care Management Teaching on Care Participation and Care Management Process of Ileostomy Patient and Caregiver: A Randomized Controlled Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-04
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:
Colorectal cancer is a type of cancer that is on the rise worldwide. Ileostomy with surgical treatment is one of the common treatment methods for this cancer. Regardless of whether the ileostomy is temporary or permanent, both patients with ileostomy and their caregivers are negatively affected physically and psychologically during this process. Patients with an ileostomy are especially at risk for ileostomy-related complications and metabolic complications. Stoma care management training on ileostomy care is critical in preventing these negativities. In this context, as a result of a real patient with ileostomy who has experience in opening an ileostomy and adapting to life with ileostomy, receiving structured training on stoma care teachings, the real patient with an ileostomy will take part in interactive stoma care management teachings in which the newly ileostomy patient and caregiver will take part together with a stoma and wound care nurses, and the processes of participation in care and care management of the newly ileostomy patient and caregiver will be improved, it is predicted that complications, physical and psychological problems that may develop related to ileostomy will be limited and contribute to public health in the long term. This research aims to determine the effect of real patient interactive stoma care management teaching on the processes of participation in care and care management of the newly ileostomy patient and caregiver. In this research, a randomized controlled full experimental research design with a post-test control group will be used. The population of the study will consist of newly ileostomy patients and their caregivers at Ankara Provincial Directorate of Health University of Health Sciences Gulhane Training and Research Hospital General Surgery Clinic. The sample of the study will be determined by using the criterion sampling method, one of the purposive sampling methods. Newly ileostomy patients and their caregivers who are eligible for the inclusion-exclusion criteria and who volunteer to participate in the study will be included. The research's data will be obtained using the Patient's Descriptive Characteristics Form, Caregiver's Descriptive Characteristics Form, Ostomy Self-Care Index, Caregiver Contribution to Self-Care in Ostomy Patient Index, Patient Health Engagement Scale, and Caregiver Health Engagement Scale. The implementation of the research will be carried out in two stages. In the first stage, real patients with an ileostomy will be identified, and training will be given to real patients on real patient interactive stoma care management with an ileostomy. In this context, to determine the expectations of individuals with stomas and their caregivers regarding stoma care management teaching, the plan was to determine the experiences of individuals with a prior permanent or temporary ileostomy/colostomy and current stomas and their caregivers regarding stoma care management education at the institution where the study was conducted. This plan was to structure the training to be delivered as part of the first stage of the study. To this end, ethics committee approval and institutional permission were obtained for the study titled "Determining the Stoma Care Education Experiences of Individuals with Stomas and Their Caregivers: A Qualitative Study." The opinions of individuals with stomas and their caregivers were collected, and the training was organized accordingly as part of the first stage of the study. In the second stage, real patient with ileostomy interactive stoma care management teaching will be applied to newly ileostomy patients and their caregivers in the intervention group, while standard stoma care management teaching will be applied to newly ileostomy patients and their caregivers in the control group. The objectives of this research are as follows: preparation of real patients with ileostomy; completion of real patients with ileostomy interactive stoma care management teaching with the intervention group; completion of standard stoma care management teaching with the control group; data analysis and statistical evaluations. It is predicted that with the real patient with ileostomy interactive stoma care management teaching, improvement will be achieved in the processes of participation in care and care management of the newly ileostomy patient and caregiver, complications, physical and psychological problems that may develop related to ileostomy will be limited, and in the long term, public health will be contributed.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 424S083 | OTHER_GRANT | The Scientific and Technological Research Council of Türkiye 1002-A Short Term Support Module | View |