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Not yet recruiting NCT07358286

MOBILE EDUCATION AND COMFORT IN OSTOMY PATIENTS

No phase Interventional Stoma Ostomy Mobile Application

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mobile Education Program Based on Kolcaba's Comfort Theory.
Who it may be relevant to
Registry conditions: Stoma, Ostomy, Mobile Application. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

THE EFFECT OF KOLCABA'S COMFORT THEORY-BASED MOBILE EDUCATION ON COMFORT LEVELS OF OSTOMY PATIENTS: A RANDOMIZED CONTROLLED TRIAL

Overview

Purpose of the Study This study aims to understand whether a mobile education program can improve comfort levels in people living with a stoma. A stoma is a surgical opening created on the abdomen to allow stool or urine to leave the body. Living with a stoma can affect daily life in many ways, including physical comfort, emotional well-being, social life, and the home environment. The education program used in this study is based on Kolcaba's Comfort Theory. This theory focuses on comfort as a whole and includes physical, emotional, social, and environmental aspects of a person's life. The study will compare people who receive mobile education with those who receive standard hospital care only. Who Can Take Part Adults aged 18 years and older who are scheduled to have colostomy, ileostomy, or urostomy surgery may take part in this study. Participants must be able to communicate in Turkish, read and understand written information, and agree to join the study voluntarily. People with severe cognitive problems, serious communication difficulties, or major vision or hearing problems will not be included. What Will Happen in the Study Participants will be randomly assigned to one of two groups: Mobile Education Group Standard Care Group Both groups will receive routine care provided by the hospital. Participants in the mobile education group will also receive access to a mobile application designed specifically for people with a stoma. This application includes: Easy-to-understand information about stoma care Animated educational videos showing step-by-step stoma care practices Guidance on skin care, pouch changing, and hygiene Information on common problems and when to seek medical help Reminders to support daily stoma care routines The mobile application can be used on smartphones and does not include diagnosis or treatment. It is for education and support only. Participants in the standard care group will receive usual hospital education and care. After the study is completed, they will also be offered the mobile education program. What Participants Will Be Asked to Do All participants will be asked to answer questionnaires that measure comfort levels at several time points: Before surgery One day after surgery Fifteen days after discharge (by phone) One month after surgery (during a clinic visit) Participants in the mobile education group will be shown how to use the application and may use it as often as they wish. Researchers may contact participants to ask about their experience using the app and to identify any difficulties. Possible Benefits Participants may gain better understanding of stoma care and feel more confident managing daily life with a stoma. The mobile education program may help reduce discomfort, support emotional well-being, and improve overall quality of life. The results of this study may help healthcare professionals develop better education tools and support programs for people living with a stoma. Risks and Safety This study does not involve experimental medical treatments. The mobile application provides education only. Personal data will not be collected through the app, and all information will be kept confidential. Participants may leave the study at any time without affecting their medical care. Why This Study Is Important Access to stoma care education can be limited due to time constraints, staff availability, and hospital resources. Mobile education may provide an easy and accessible way for people to receive reliable information whenever they need it. This study will help determine whether a comfort-focused mobile education program can support people living with a stoma and improve their overall comfort and well-being.

Detailed description

Stoma creation is one of the most commonly used surgical interventions in cancers of the urinary or gastrointestinal system, inflammatory bowel diseases, and traumatic conditions (United Ostomy Associations of America, 2021). The most common indications for stoma formation include Crohn's disease, diverticulitis, colon and rectal cancers, bladder cancer, adenomatous polyposis, neurogenic bladder dysfunction, ulcerative colitis, and traumatic ileus. The primary purposes of stoma creation are to prolong life expectancy, eliminate pathological conditions, and improve quality of life (Aksoy \& Çavdar, 2015; Ayalon \& Bachner, 2019; Barnwell, 2015; Burch, 2015; Tonolini, 2019; Wound, 2018).

Depending on the indication, a stoma may be temporary or permanent (Aksoy \& Çavdar, 2015; Ayalon \& Bachner, 2019). Temporary stomas account for approximately forty percent of all stomas. Colorectal cancers are the most common reason for permanent stoma creation. This type of cancer is among the five most common cancers in Türkiye (Ayalon \& Bachner, 2019). According to the 2024 data from the World Health Organization's International Agency for Research on Cancer, colon cancer ranks second among cancer-related causes of death worldwide (World Health Organization, 2024).

It is estimated that approximately two million people worldwide live with a stoma, with around seven hundred thousand residing in Europe (Claessens et al., 2015). In the United States, an average of one hundred thirty thousand people undergo ostomy surgery each year, and it is estimated that approximately one million individuals live with urinary or fecal diversions (United Ostomy Associations of America, 2021). The number of individuals living with an ostomy is reported to exceed one hundred thousand in the United Kingdom and range between seven hundred twenty-five thousand and one million in North America (İncesu \& Ulupınar, 2022). In Türkiye, the exact number of individuals living with a stoma is not clearly known (Çevik et al., 2020). However, due to the high prevalence of colorectal cancers, the rate of stoma creation is estimated to be considerable (Ayık et al., 2023).

After stoma surgery, individuals may experience both positive and negative physical, social, and psychological effects (Ayaz et al., 2008; Pinquart, 2010; Grant et al., 2013; Alptekin et al., 2023). Although survival rates increase significantly following stoma surgery, many complications may also occur. These complications can reduce quality of life, negatively affect physical and mental health, increase hospital length of stay, raise morbidity rates, and lead to higher healthcare costs. Such complications represent some of the negative consequences of living with a stoma (Kuzu et al., 2002; Karadağ et al., 2011; Salvadalena, 2013; Goldberg et al., 2018; Tonolini, 2019; Ayık et al., 2020; Hsu et al., 2020).

Adapting to life after stoma surgery is a challenging and time-consuming process. During this period, individuals need accurate education and adequate social support. Studies have shown that individuals who receive sufficient and appropriate education on stoma care demonstrate higher levels of adaptation compared to those who do not (Aminisani et al., 2017). Nurses play a crucial role in the adaptation process during both preoperative and postoperative periods. Their responsibilities include providing education, offering counseling services, informing individuals with a stoma, building self-confidence, and supporting post-discharge care (Duluklu \& Çelik, 2019).

The role of stoma and wound care nurses in stoma management is invaluable. However, not all hospitals in Türkiye employ stoma and wound care nurses, and even in institutions where they are available, providing continuous care across all shifts is often not possible (Ayık et al., 2023). Kang et al. (2025) reported that individuals with a stoma face complex physiological, psychological, and social challenges during the postoperative period. The same study emphasized that holistic care and continuous support from healthcare professionals play a critical role in adaptation to life with a stoma.

Adaptation to stoma is influenced by factors such as individual competencies, demographic characteristics, and social support systems (Öztürk, 2019; Akil \& Taylan, 2020). Similar to findings in other countries, studies conducted in Türkiye indicate that quality of life is negatively affected after stoma creation (Duluklu et al., 2019). Individuals living with a stoma frequently experience issues such as odor, leakage, body image disturbance, constipation, diarrhea, difficulty bathing, challenges related to sexuality, travel, and religious practices, all of which negatively affect quality of life (Duluklu et al., 2019).

Several international studies have reported reduced quality of life among individuals living with a stoma. In Brazil, Salomé et al. (2019) reported a mean quality of life score of 26.16 out of 105. In Malaysia, Thamilselvam et al. (2020) found that many participants reported family neglect, lack of sexual intimacy, limited social participation, and feelings of social exclusion. In the Netherlands, Gooszen et al. (2021) reported that twelve percent of individuals isolated themselves within the first three months after surgery, while seventy-two percent experienced problems related to clothing, diet, skin irritation, and leakage. Similarly, studies conducted in Iran and other countries have highlighted challenges related to nutrition, psychological changes, social relationships, physical activity, religious practices, and economic difficulties (Dabirian et al., 2022; Brady et al., 2025).

One of the key factors influencing quality of life among individuals living with a stoma is comfort. Comfort is considered a fundamental human need and a desired state throughout life (Yücel, 2011; Orkun et al., 2017). In nursing, comfort involves identifying patient needs, implementing appropriate interventions, and evaluating outcomes. Comfort is a complex, holistic, and individualized concept closely associated with the art of nursing (Çınar Yücel, 2011). Nursing care that prioritizes comfort in the postoperative period may accelerate recovery and improve overall well-being (Akalın et al., 2020).

Advancements in technology have increasingly contributed to disease management and quality of life assessment in healthcare. Mobile health applications installed on smartphones provide practical tools for disease management, follow-up, and patient support. These technologies facilitate home-based monitoring, reduce hospital workload, and lower healthcare costs (Langer et al., 2021). Studies have shown that mobile applications increase patient awareness, self-evaluation skills, and self-management abilities (Tang et al., 2020).

Mobile learning allows individuals to access information, interact with others, and receive instant feedback without time or location constraints (Bulut Özek \& Gür, 2021). Mobile health interventions offer several advantages, including improved disease management, enhanced preventive care, effective monitoring of chronic conditions, reduced costs, and increased patient autonomy (Gruessner, 2015; Ardahan et al., 2018). Despite growing evidence supporting mobile health interventions, studies specifically examining the effect of mobile education on comfort levels in individuals living with a stoma remain limited. Therefore, this study aims to evaluate the effect of a comfort theory-based mobile education program on the comfort levels of individuals living with a stoma.

Type of the study: It is planned as a randomized controlled experimental and single-blind study.

Study setting(s): The study will be conducted in the urology and general surgery units of Izmir City Hospital.

Study Population / Sample

The population of the study will consist of patients who are hospitalized in the urology and general surgery units of Izmir City Hospital and are scheduled to undergo ostomy surgery between January 2026 and May 2026. The sample of the study will consist of patients who were hospitalized in the urology and general surgery units of Izmir City Hospital between January 2026 and May 2026, who meet the sample selection criteria of the study and who agree to participate in the research.

Considering the sample selection criteria, the study will include two groups, an experimental group and a control group. In order to determine the sample size, a power analysis was conducted using the G\*Power 3.1.7.9 program to evaluate the comfort levels of ostomy patients and to determine the effect of education provided through a mobile education program based on Kolcaba's Comfort Theory on comfort levels. Since no similar reference study could be identified, the effect size determined by Cohen was used for the power analysis. Based on the power analysis calculated according to the difference between the experimental and control groups, with an alpha value of 0.05, an effect size of 0.8, and a theoretical power of 90%, the minimum sample size was calculated as 68 participants (34 in the experimental group and 34 in the control group). Patients will be assigned to the study groups using a computer-based randomization program (https://www.random.org/).

Hypothesis(es):

H0: Mobile education based on Kolcaba's Comfort Theory does not affect the comfort levels of patients with a stoma.

H1: Mobile education based on Kolcaba's Comfort Theory affects the comfort levels of patients with a stoma.

Data Collection Method

In data collection, the Patient Identification Form, the General Comfort Questionnaire, and a mobile education program including an animation video explaining stoma care for patients with a stoma based on Kolcaba's Comfort Theory will be used.

General Comfort Questionnaire

The General Comfort Questionnaire was developed by Kolcaba in 1992. The Turkish validity and reliability study was conducted by Kuğuoğlu and Karabacak in 2008. The scale consists of 48 items and three subdimensions (relief, ease, and transcendence) and is scored using a four-point Likert scale. The questionnaire includes both positively and negatively worded items, with negative items being reverse-coded during analysis.

The total score obtained from the scale is divided by the number of items to calculate the mean score. The minimum possible score is 48 and the maximum possible score is 192. According to the mean comfort scores, 0-48 indicates poor comfort, 49-96 indicates moderate comfort, 97-144 indicates good comfort, and 145-192 indicates very good comfort. Higher scores indicate higher levels of comfort. The Cronbach's alpha coefficient of the Turkish version of the scale is 0.85 (Kolcaba, 2003; Kuğuoğlu \& Karabacak, 2008).

Mobile Education Content for Patients With a Stoma Based on Kolcaba's Comfort Theory and Development Stages

The design process of the mobile application developed for patients with a stoma will be planned in five stages. These stages include Analysis, Design, Development, Implementation, and Evaluation.

Stage 1: Analysis Phase of the Mobile Application

This is the initial stage in which the purpose of the mobile application is determined. The mobile application development process begins with the analysis phase, during which the goals and scope of the project are defined. Based on a comprehensive literature review focusing on factors affecting adaptation to life with a stoma, improvement of quality of life, and enhancement of comfort levels, the content of the mobile application will be developed.

The cost and software requirements of the mobile application will also be determined during this phase. Costs will include content development, animation-based video production, and mobile application software development. Content costs may vary depending on the use of photographs, videos, animations, and other materials. The application content will be supported by an animation-based nursing sto

Interventions

  • Behavioral Mobile Education Program Based on Kolcaba's Comfort Theory
    The intervention consists of a mobile education program based on Kolcaba's Comfort Theory. The program includes animation-based educational content on stoma care, pouch changing, peristomal skin care, and postoperative self-care. The mobile education is designed to support patients in managing their stoma and to improve their overall comfort levels.

Primary outcome measures

  • Comfort Level of Patients with a Stoma [Time frame: Preoperative period, postoperative day 1, postoperative day 15, and 1 month after surgery]

Eligibility criteria

Inclusion criteria

  • Adults aged 18 years and older
  • Patients with a stoma (colostomy or urostomy)
  • Ability to use a smartphone or mobile device
  • Willingness to participate in the study
  • Ability to provide informed consent

Exclusion criteria

  • Cognitive impairment that prevents understanding of the study procedures
  • Severe psychiatric disorders
  • Inability to use mobile technology
  • Participation in another interventional study during the study period

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Tang, Y., et al. (2020). Health management app use and quality of life. https://doi.org/10.1038/s43856-023-00246-4 Tonolini, M. (2019). A closer look at the stoma. Insights into Imaging, 10(1), 1-15. https://doi.org/10.1186/s13244-019-0722-x United Ostomy Associations of America. (2021). Welcome to UOAA. https://www.ostomy.org Wang, M., Liao, W., Chen, X. (2019). Effects of a mindfulness-based int
  • Hsu, M. Y., et al. (2020). Preoperative stoma site marking decreased stoma and peristomal complications. Journal of Wound Ostomy & Continence Nursing. https://doi.org/10.1097/WON.0000000000000634 Kang, Y., et al. (2025). Life experience of patients living with urostomy: A meta-synthesis. Psycho-Oncology, 34, e70096. https://doi.org/10.1002/pon.70096 Karadağ, A., et al. (2011). Ostomili bireylere y
  • Barnwell, A. (2015). Advanced nursing practice in colorectal and stoma care. Gastrointestinal Nursing, 13(1), 42-48. https://doi.org/10.12968/gasn.2015.13.1.42 Brady, R. R. W., et al. (2025). The prevalence of leakage, peristomal skin complications and impact on quality of life in the first year following stoma surgery. Nursing Reports, 15, 107. https://doi.org/10.3390/nursrep15030107 Bulut Özek,
  • Akalın, B., Modanlıoğlu, A. (2020). 'Ameliyathane hemşiresi olmak': Nitel bir çalışma. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 23(1), 100-108. Aksoy, G., Çavdar, İ. (2015). Sindirim sistemi (gastrointestinal sistem) stomalarında bakım. In N. Akyolcu & N. Kanan (Eds.), Yara ve Stoma Bakımı (1. Baskı, ss. 67-81). Nobel Tıp Kitapevleri. Aminisani, N., Nikbakht, H., Jafarabadi, M. A., & Shamsh

Identifiers

NCT: NCT07358286 · EGEU_PHD_STOMA_2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗