The Effect of Mobile Technology-Based Education Combined With Relaxation Exercise on Stress, Symptom Severity and Quality of Life in Patients With Irritable Bowel Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Perceived Stress Scale
研究概览
简要总结
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder characterized by chronic recurrent abdominal pain, bloating, changes in bowel habits or bowel movements (1-3). Pharmacological and nonpharmacological methods are used in the treatment of IBS. In addition to lifestyle changes such as dietary changes, physical activity, and stress reduction, relaxation techniques, herbal medicines, and nutritional supplements are important nonpharmacological methods used by IBS patients.
Progressive muscle relaxation exercises (PGE) have been reported to positively affect IBS symptoms, patients' quality of life, anxiety, and depression. PGE training in patients with IBS has been found to improve general health perception, reduce symptom severity, and healthcare costs. (7-9). PGE is a complementary treatment and is among advanced nursing practices (10, 11).
In this study, a mobile application will be developed to educate patients about IBS and PGE. It is thought that this application will reduce the severity of patients' symptoms and increase their quality of life. This study is planned to determine the effects of mobile technology-based training combined with relaxation exercises on stress, symptom severity and quality of life in patients with irritable bowel syndrome.
详细描述
Definition of Irritable Bowel Syndrome Irritable bowel syndrome is a common functional gastrointestinal disorder characterized by chronic recurrent abdominal pain, bloating, changes in bowel habits or bowel movements. IBS is a chronic, often debilitating, and highly prevalent disorder of the brain-gut interaction that affects 5% to 10% of the population. (8, 12)
Epidemiology of Irritable Bowel Syndrome IBS is a common condition affecting 9% to 23% of the general population, 80% of whom are women, with a significant impact on quality of life and health care costs. Its prevalence is lower in individuals aged 50 years and older. The prevalence of IBS in developed countries has been reported to reach up to 20% of the population.
Population-based epidemiological studies of IBS have shown prevalence rates ranging from 5% to 10% in most countries. It varies between 7% in Southeast Asia and the Middle East studies, 11.8-14.0% in North America, Northern Europe and Australia studies and 15.0-21.0% in Southern Europe, Africa and South America studies. 24 It has been stated that the prevalence of IBS in the general population in China is 6.5%. 25 A national study among middle and high school students in Japan showed that the prevalence of IBS was 18.6%. 26 In a study published in 2020, the prevalence of IBS in the USA, Canada and the United Kingdom was similar between 4.4% and 4.8%.
In our country, studies conducted in İzmir, Sivas, Elazığ and Diyarbakır have stated that the prevalence of IBS varies between 6.2% and 19.1%. The prevalence of IBS in our country varies between 6.3-27% (4-6, 13).
Pathophysiology of Irritable Bowel Syndrome The pathophysiology of IBS is complex, and the pathophysiological mechanisms underlying the syndrome are heterogeneous and not fully understood. However, factors leading to IBS include alterations in brain-gut communication, serotonin metabolism disorders, intestinal motility disorders, visceral hypersensitivity, gastrointestinal infections, altered microbiota, food intolerance, genetics, stress, and psychological factors (8, 13, 14).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older, applied to the polyclinic where the study was conducted,
- •Have been diagnosed with IBS according to Rome IV criteria,
- •Have a smart phone or computer,
- •Have no illness that would prevent them from doing progressive muscle relaxation exercises (heart failure, chronic obstructive pulmonary disease, asthma, pregnant, etc.),
排除标准
- •Having communication problems
结局指标
主要结局
Perceived Stress Scale
时间窗: three months
The Perceived Stress Scale (PSS) consists of a total of 14 items. PSS is designed to measure how stressful a person perceives certain situations in their life. Each item is evaluated on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)". The 7 items with positive expressions are scored reversely (items 4, 5, 6, 7, 9, 10, and 13). PSS-14 scores range from 0 to 56. A high score indicates a high perception of stress.
IBS symptom severity score
时间窗: three months
The IBS symptom severity score (IBS-SSS) was developed to assess the severity of symptoms in IBS. The scale is widely used to monitor the progression and treatment of the disease. The IBS-SSS assesses the severity and duration of abdominal pain (abdominal pain, painful days), abdominal bloating (bloating), satisfaction with bowel habits (bowel habits), and quality of life. The scale consists of a total of 5 questions, each with a score ranging from 0 to 100. The total score of the scale ranges from 0 to 500, with higher scores indicating increased severity of the disease. Scores between 0-74 on the scale are classified as remission, 75-174 as mild, 175-299 as moderate, and 300 and above as severe IBS.
Irritable Bowel Syndrome Quality of Life
时间窗: three months
Irritable Bowel Syndrome Quality of Life (IBS QOL) Scale The Irritable Bowel Syndrome Quality of Life (IBS-QOL) Scale was developed to assess the quality of life in patients with Irritable Bowel Syndrome. The 5-point Likert-type scale prepared for IBS patients consists of 34 items and 8 sub-dimensions; The sub-dimensions are mood, activity, body image, health, food avoidance, social response, sexuality and social relationship. The raw scores obtained are evaluated by converting them out of 100 using the formula \[Transformed score = (Scale raw score - number of items / maximum possible score - minimum possible score) x 100\]. The sub-dimension and total scores of the IBS-QOL scale vary between 0-100. Increasing scale scores indicate that the health-related quality of life of individuals increases.
次要结局
未报告次要终点