Clinical trial NCT06979102: The Effect of Real Patient Interactive Stoma Care Management Teaching
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Ileostomy - Stoma
Caregiver
Care Management
Care Participation
Real Patient Interaction
Keywords: Caregiver
Ileostomy patient
Care management
Care participation
Real patient interaction
Teaching intervention
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: To determine the processes of participation in care of the newly ileostomy patient with the Ostomy Self-Care Index
timeFrame: The second stoma care management teaching was completed before discharge, an average postoperative 6th day; The 2nd month after discharge.
measure: To determine the processes of participation in care of the caregiver with the Caregiver Contribution to Self-Care in Ostomy Patient Index
timeFrame: The second stoma care management teaching was completed before discharge, an average postoperative 6th day; The 2nd month after discharge.
measure: To determine the processes of care management of the caregiver with the Caregiving Health Engagement Scale
timeFrame: The second stoma care management teaching was completed before discharge, an average postoperative 6th day; The 2nd month after discharge.
measure: To determine the processes of care management of the newly ileostomy patient with the Patient Health Engagement Scale
timeFrame: The second stoma care management teaching was completed before discharge, an average postoperative 6th day; The 2nd month after discharge.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Provincial Directorate of Health University of Health Sciences Gülhane Training and Research Hospital
Study officials:
References: