Clinical trial NCT06385613: The Effect of Mobile-Based Education on Self-Care, Quality of Life and Complications in Patients With Intestinal Stoma
Official title: The Effect of Mobile-Based Education on Self-Care, Quality of Life and Complications in Patients With Intestinal Stoma
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intestinal Stoma Site Hemorrhage
Intestinal Stoma Leakage
Life Style, Healthy
Keywords: intestinal stoma
mobile-based education
self-care
quality of life
complication
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Groups will be divided into control and intervention. People in the group will be randomly assigned in a simple randomized manner.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Stomas are most commonly used in the gastrointestinal tract as ileostomy or colostomy. Although colorectal cancers are the most important factor causing intestinal stoma opening, intestinal ostomies are also used in cases such as congenital anomalies, obstructive or inflammatory bowel diseases, traumas requiring surgery, large defects caused by colorectal injuries as well as sigmoid colon volvulus and ischemic colitis. In stoma surgery performed to increase the duration and quality of life of individuals, the patient's compliance with the stoma and awareness of possible complications are important. Conditions such as peristomal skin problems, noisy bowel movements, stool leakage and pain make it difficult to adapt to the stoma.In addition, despite all the advances in stoma care products and surgical techniques, individuals are faced with stoma complications. Therefore, individuals with stoma should be closely monitored for complications. Inappropriately selected stoma site or bag/adapter system, lack of knowledge and skills related to stoma care can be listed among the possible causes of complications. Complications such as edema, bleeding, ischemia and mucocutaneous separation may develop in the first days after stoma surgery. In studies evaluating patients in terms of stoma compliance and complications in the literature, it has been observed that mobile-based trainings given to patients increase their stoma compliance and reduce the incidence of complications. With the mobile-based training planned to be used in the study, it is thought to contribute to the ability of individuals to perform stoma care independently. With the decrease in peristomal skin lesions and stoma complications, it is predicted that the quality of life of patients with stoma will increase, self-care competence will be formed, and health expenditures and therefore national health expenditures will decrease. It is thought that this mobile training application will not only provide support to patients with stoma but also guide healthcare professionals. It will also contribute to closing the shortage of stoma and wound care nurses in hospitals.

Detailed description: There are many factors that make it difficult for individuals to adapt and cope with the stoma. The most important components in the prevention and treatment of complications can be listed as marking the stoma site, evaluation of the peristomal skin, placement and removal of the appropriate bag/adapter system with the correct technique, close monitoring of patients, patient education, and performing medical and surgical interventions. Nursing care; complication management, patient care, nutrition, excretion, family relations, sexuality, sexuality, worship, work life, social life should be carried out by determining the problems related to the areas and paying attention to the privacy areas. In this context, nursing care should include a care process that starts at the time of hospitalization and covers the post-discharge period. Nursing care should aim to diagnose problems, increase stoma compliance and quality of life, physical/psychological recovery and gain stoma care skills.

Easy access to online information presents a dichotomy in terms of risk and benefit. If the patient is unable to assess the quality of the information and its relevance for his/her specific situation, decision-making may be negatively affected, leading to negative outcomes. The benefit of digital communication, especially in the context of individuals with ostomies, is that it provides individuals, families and communities with scientific information about informed practices. This allows the individual to identify and indicate early signs of complications. They can also receive guidance on their problems, contributing to an easier and more appropriate decision-making process. Providing adequate stoma care enables patients to cope better with their stoma and is therefore important for improving their quality of life. Although the importance of stoma care has been reported, it remains inadequate in many aspects. Innovative mobile applications have a significant potential to overcome these shortcomings. self-efficacy and participation in care can be improved by using mobile applications. It has been stated that patients supported by mobile applications are better supported in stoma care and have more self-efficacy, so individuals receiving support will have a good quality of life.In a study conducted in Turkey, it was reported that individuals who used a mobile application had higher levels of stoma compliance, ability to care for the stoma on their own, and satisfaction with the training they received than those who used a printed booklet. However, it was stated that the application was not effective in preventing peristomal skin lesions. It was stated that additional studies are needed to determine which features of a mobile application may be useful in preventing such lesions. For this reason, it is thought that the mobile-based training application to be developed will contribute to the patients to accept and manage the process faster, to have competence in stoma care, and to perform stoma care independently with well-managed care and education.

Eligibility criteria: Inclusion Criteria:

* Able to understand and speak Turkish,
* Not visually or hearing impaired,
* No neurological disease affecting psychiatric or cognitive status,
* Decision to perform ileostomy or colostomy,
* No previous experience with intestinal stoma,
* Patients who can use telephone and internet will be included in the study.

Exclusion Criteria:

* Don't lose your life
* Development of a serious complication after surgical intervention

Primary outcomes:
measure: Adaptation of Quality Life Scale
timeFrame: Average 3 months after completion of stoma care education.
measure: Ostomy Self-Care Index
timeFrame: Average 3 months after completion of stoma care education.
measure: Pittman Ostomy Complication Severity Index
timeFrame: Average 3 months after completion of stoma care education.
measure: Peristomal Skin Tool
timeFrame: Average 3 months after completion of stoma care education.
measure: Ostomy Adjustment Inventory-23
timeFrame: Average 3 months after completion of stoma care education.
measure: Computer System Usability Questionnaire
timeFrame: Average 3 months after completion of stoma care education.
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University Faculty of Nursing
Study officials:
References:
citation: Ambe PC, Kurz NR, Nitschke C, Odeh SF, Moslein G, Zirngibl H. Intestinal Ostomy. Dtsch Arztebl Int. 2018 Mar 16;115(11):182-187. doi: 10.3238/arztebl.2018.0182.
citation: Azer SA, AlKhawajah NM, Alshamlan YA. Critical evaluation of YouTube videos on colostomy and ileostomy: Can these videos be used as learning resources? Patient Educ Couns. 2022 Feb;105(2):383-389. doi: 10.1016/j.pec.2021.05.023. Epub 2021 May 18.
citation: Azodo, Clement C., and Vivian O. Omuemu. 2017. "Perception of Spirituality, Spiritual Care, and Barriers to the Provision of Spiritual Care among Undergraduate Nurses in the University of Lagos, Nigeria." Journal of Clinical Sciences 14(1):119-25. doi: 10.4103/jcls.jcls.
citation: Capilla-Diaz C, Bonill-de Las Nieves C, Hernandez-Zambrano SM, Montoya-Juarez R, Morales-Asencio JM, Perez-Marfil MN, Hueso-Montoro C. Living With an Intestinal Stoma: A Qualitative Systematic Review. Qual Health Res. 2019 Jul;29(9):1255-1265. doi: 10.1177/1049732318820933. Epub 2019 Jan 25.