The Effect of Real Patient Interactive Stoma Care Management Teaching

NCT ID: NCT06979102

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-13
• Study Completion Date: 2026-06-12

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.

Conditions

Ileostomy - Stoma; Caregiver; Care Management; Care Participation; Real Patient Interaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

The real patient interactive stoma care management teaching will be carried out with ileostomy patients who have recently had their ileostomy opened and their caregivers in the intervention group.

Group Type: EXPERIMENTAL

Real Patient Interactive Stoma Care Management Teaching

Intervention Type: OTHER

The real patient interactive stoma care management teaching will be carried out with ileostomy patients who have recently undergone ileostomy surgery and their caregivers in the intervention group. The 2nd month after discharge, the newly ileostomy patients and their caregivers will be asked one open-ended question to elicit their thoughts and suggestions regarding the real patient interactive stoma care management teaching. The question is: "A real patient with a previous ileostomy participated in the stoma care management teaching. He demonstrated how to perform ileostomy care on himself and shared his experiences and suggestions regarding adapting to life with an ileostomy. What are your thoughts and suggestions regarding this teaching?"

Control Group

The standard stoma care management teaching will be carried out with ileostomy patients who have recently had their ileostomy opened and their caregivers in the control group.

Group Type: ACTIVE_COMPARATOR

Standard Stoma Care Management Teaching

Intervention Type: OTHER

The standard stoma care management teaching will be carried out with ileostomy patients who have recently had their ileostomy opened and their caregivers in the control group.

Interventions

Real Patient Interactive Stoma Care Management Teaching

The real patient interactive stoma care management teaching will be carried out with ileostomy patients who have recently undergone ileostomy surgery and their caregivers in the intervention group. The 2nd month after discharge, the newly ileostomy patients and their caregivers will be asked one open-ended question to elicit their thoughts and suggestions regarding the real patient interactive stoma care management teaching. The question is: "A real patient with a previous ileostomy participated in the stoma care management teaching. He demonstrated how to perform ileostomy care on himself and shared his experiences and suggestions regarding adapting to life with an ileostomy. What are your thoughts and suggestions regarding this teaching?"

Intervention Type: OTHER

Standard Stoma Care Management Teaching

The standard stoma care management teaching will be carried out with ileostomy patients who have recently had their ileostomy opened and their caregivers in the control group.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

For newly ileostomy patients;

• 18 years of age and over,
• Speak, read, write, and understand Turkish,
• Not having received teaching on stoma care and management before,
• No previous experience in stoma care and management. For caregivers;
• 18 years of age and over,
• Speak, read, write, and understand Turkish,
• Being an informal (unpaid) caregiver of a newly ileostomised patient,
• Not having received teaching on stoma care and management before,
• No previous experience in stoma care and management.

Exclusion Criteria

For newly ileostomy patients; - Not participating in stoma care management teaching and follow-ups after ileostomy opening.

For caregivers;

• Not participating in stoma care management teaching and follow-ups after ileostomy opening.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Busra Caz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Provincial Directorate of Health University of Health Sciences Gülhane Training and Research Hospital

Ankara, Turkey, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

424S083

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024/10-28

Identifier Type: -

Identifier Source: org_study_id