Effect of Hawthorn Vinegar, Black Mulberry Syrup and Green Tea on Quality of Life Related to Oral Mucositis and Oral Health in Individuals With Diabetes: Single Blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Oral Health Related Quality of Life Scale (OHQoL-UK)
研究概览
简要总结
In this context, this study investigated the quality of life related to oral mucositis and oral health in patients with DM using hawthorn vinegar, black mulberry syrup and green tea.
详细描述
Diabetes Mellitus (DM) is a chronic metabolic disease that causes serious damage to the heart, blood vessels, eyes, kidneys and nerves. Both the number of cases and the prevalence of diabetes have been increased rapidly over the past 30 years. According to the report of the International Diabetes Federation (IDF) Report, approximately 537 million people worldwide (700 million in 4045) have diabetes and 6.5 million people were reported to have died due to diabetes in 2021. In Turkey, it is estimated that approximately 9 million people (about 13.5 million in 2045) are diagnosed with diabetes and approximately 80 thousand people will die from diabetes.
Prolonged hyperglycemia in DM can lead to microvascular (nephropathy, retinopathy and neuropathy) and macrovascular (peripheral vascular disease, hypertension, cerebrovascular disease, ischaemic heart disease) complications. However, due to poorly controlled DM, complications can be seen in the oral mucosa of patients with many immunological and metabolic changes. Oral complications seen in patients with DM include hyposalivation, xerostomia, bacterial, viral and fungal infections, poor wound healing, increased severity and incidence of caries, gingivitis and periodontal disease, periapical abscess, and burning mouth syndrome (BMS). These complications can lead to the development of oral mucositis in patients.
Many pharmacological and non-pharmacological agents are used in the prevention/treatment of oral mucositis. According to the classification of the National Center for Complementary and Integrative Health (NCCAM), complementary therapies methods are divided into three groups as nutritional, psychological and physiological and other complementary approaches. However, it is reported in the literature that complementary therapies such as cryotherapy (oral cooling), honey, propolis, vitamin E, selenium, aloe vera, black mulberry, apple cider vinegar, rose water and green tea are effective in the treatment of oral mucositis. Again in the literature, there are studies in which the effect of black mulberry syrup in patients with Chronic Obstructive Pulmonary Disease (COPD), apple cider vinegar and rose water mixture in cancer patients and green tea in the treatment of oral mucositis has been proven.
Oral mucositis is one of the oral diseases that can cause oral dysfunction, dysphagia and reduced oral health-related quality of life in patients. Oral and dental health affects a person's quality of life by affecting their physiological, psychological and social functioning. However, improving oral health is part of nursing care. In order to maintain a good quality of life, it is necessary to improve awareness of oral complications that occur in patients with DM. In the literature reviewed, only one experimental study was found in cancer patients in which oral mucositis-related quality of life was evaluated. There is no international or Turkish study on the treatment of oral mucositis in patients with DM. There are also no studies comparing hawthorn vinegar, black mulberry syrup and green tea in different sample groups. In this context, this study investigated the quality of life related to oral mucositis and oral health in patients with DM using hawthorn vinegar, black mulberry syrup and green tea.
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 (Investigator)
盲法说明
The principal investigator completed the consent and assent forms after explaining the purpose of the study to all participants. In the research planned as a single-blind randomized controlled clinical study, the other researcher who applied the data collection tools to reduce bias was not told who the experimental groups (hawthorn vinegar group, black mulberry syrup group, green tea group) and the patients with DM in the control group were.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overs 18 years of age,
- •Voluntary participation in the study,
- •Be lucid and able to communicate,
- •Be diagnosed with DM for at least 3 months ago,
- •Willing to use either hawthorn vinegar, black mulberry syrup or green tea as a complementary treatment for oral mucositis,
- •HbA1c ≥ 7% (Wang and Hng, 2021),
- •Oral mucositis score of 14< in oral assessment.
排除标准
- •Having a known psychological disorder,
- •Having HbA1c <7%,
- •Not having oral mucositis,
- •Having hearing loss.
结局指标
主要结局
Oral Health Related Quality of Life Scale (OHQoL-UK)
时间窗: 14 Days
The 5-point Likert-type scale, which consists of a total of 16 items to determine the degree of impact of teeth, gums, mouth or prosthesis, consists of 4 dimensions: "symptom" (items 1-2), "physical condition" (items 3-7), "psychological condition" (items 8-12) and "social condition" (items 13-16). Each item in the scale is scored as "Very bad effect-1, bad effect-2, no effect-3, good effect-4, very good effect-5". The total score of the scale varies between 16-80, and a high score indicates a high level of oral and dental health-related quality of life. The Cronbach alpha value of the scale was reported as 0.94. "OHQoL-UK" was administered again on the 7th day (interim-measurement) and 14th day/end of the study (post-test).
Oral Assessment Guide (OAG)
时间窗: 14 Days
The "OAG" is useful for assessing and recording the individual's daily oral condition, as well as detecting the presence of mucositis and evaluating the effectiveness of treatment. The "OAG" consists of 8 categories including voice, dysphagia, lips, tongue, saliva, mucous membranes, gums and teeth/prostheses. "OAG" was administered again on the 7th day (interim-measurement) and 14th day/end of the study (post-test).
次要结局
未报告次要终点
研究者
Hatice Demirağ, Ph.D
Assistant professor
Gümüşhane Universıty
