The Effect of Real Patient Interactive Stoma Care Management Teaching

Not Applicable

• Conditions: Care Participation; Ileostomy - Stoma; Caregiver; Care Management; Real Patient Interaction

• Registration Number: NCT06979102
• Lead Sponsor: Hacettepe University

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 Gülhane 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 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

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-13
• Study First Submitted: 2025-04-27
• Study First Submitted QC: 2025-05-09
• Last Update Submitted: 2025-05-09
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-06-12
• Study Completion: 2026-06-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To determine the processes of participation in care of the newly ileostomy patient with the Ostomy Self-Care Index	The second stoma care management teaching was completed before discharge, an average postoperative 6th day; The 2nd month after discharge.	The scale has a 5-point Likert structure. The scale score is determined by adding the scores obtained from each item in the scale. As the scale score increases, the level of self-care management of the ostomy patient increases.
To determine the processes of participation in care of the caregiver with the Caregiver Contribution to Self-Care in Ostomy Patient Index	The second stoma care management teaching was completed before discharge, an average postoperative 6th day; The 2nd month after discharge.	The scale has a 5-point Likert structure. The scale score is determined by adding the scores obtained from each item in the scale. As the scale score increases, the caregiver's support for the stoma-related self-care of the patient with an ostomy increases.
To determine the processes of care management of the caregiver with the Caregiving Health Engagement Scale	The second stoma care management teaching was completed before discharge, an average postoperative 6th day; The 2nd month after discharge.	The scale has a total of 6 items and each item includes 4 statements and 7 options (A, B, C, D, E, F and G); options A and B are in the denial phase and have a score of 1, options C and D are in the hyperactivation phase and have a score of 2, options E and F are in the drowning phase and have a score of 3, option G is in the balance phase and has a score of 4; the scores of the caregiver for each item are ranked and the median value of the scores shows the participation phase in which the caregiver is located.
To determine the processes of care management of the newly ileostomy patient with the Patient Health Engagement Scale	The second stoma care management teaching was completed before discharge, an average postoperative 6th day; The 2nd month after discharge.	The scale has a total of 5 items and each item contains 4 statements and 7 options (A, B, C, D, E, F and G); A and B options are in the blackout phase and have a score of 1, C and D options are in the arousal phase and have a score of 2, E and F options are in the adhesion phase and have a score of 3, G option is in the eudaimonic project and has a score of 4; the scores the patient receives for each item are listed and the median value of the scores shows the participation phase the patient is in.

Trial Locations

Locations (1)

Ankara Provincial Directorate of Health University of Health Sciences Gülhane Training and Research Hospital; 🇹🇷 Ankara, Turkey