THE EFFECT OF KOLCABA'S COMFORT THEORY-BASED MOBILE EDUCATION ON COMFORT LEVELS OF OSTOMY PATIENTS: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 68
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors are blinded to group allocation. Participants are not informed about their group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
Gökçe Nur Taşkıran
PhD Student, Nursing
Ege University