Effect of Autogenic Relaxation Training on Irritable Bowel Syndrome In Adult Females
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Irritable Bowel Syndrome Severity Scoring System
研究概览
简要总结
This study will be conducted to determine the effect of autogenic relaxation training on irritable bowel syndrome in adult females.
详细描述
This study is significant as it explores the potential of autogenic relaxation to improve the symptoms of irritable bowel syndrome.
Epidemiologic studies have reported that the prevalence of IBS is approaching 11% globally.
Patients with irritable bowel syndrome have a perception of reduced quality of life and a high presence of psychological/ psychiatric disorders such as depression, anxiety, phobias, panic, somatization and obsessive disorder, and in the past these disorders were considered an etiological factor of the syndrome. Psychopathological disorder is currently thought to be a comorbid factor that can exacerbate symptoms. Patients with irritable bowel syndrome also have a high level of perceived stress and in most cases sleep disturbances.
Autogenic relaxation training (ART) is a standardized relaxation technique developed by Schultz around 1930 that uses the mental repetition of six systematic exercises (heaviness, warmth, calm and regular heart function, self-regulation of respiration, warmth in the upper abdomen area, and agreeable cooling of the forehead) to decrease sympathetic tone and induce a general disconnection of the organism. ART is simple to learn and easy to practice following brief training. The repeated practice of the exercises increases the person's capacity to induce ever-deeper relaxation and fosters the accumulation of therapeutic benefits.
The mechanism of action of this relaxation technique lies in the relaxation response, as opposed to the stress response, which involves a complex interplay of the endocrine, immune, neurological, and psychological systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with irritable bowel syndrome (IBS) based on Rome IV diagnostic criteria constipation- predominant IBS.
- •Their body mass index 25- 30.
排除标准
- •Organic gastrointestinal disorder, thyroid dysfunction, respiratory, renal, hepatic disorder.
- •Pregnancy, hematological disease, neurological and psychiatric disease.
- •Previous history of stomach or intestinal excision.
研究组 & 干预措施
Autogenic relaxation training with aerobic exercise and lifestyle modification
Participants in this group will practice autogenic relaxation training with aerobic exercise and lifestyle modification. The Intervention will last for 8 weeks, with autogenic relaxation training sessions conducted one time per week under physiotherapist's supervision. In addition, aerobic exercise will be three sessions per week for 8 weeks.
干预措施: Autogenic relaxation training (Other)
Autogenic relaxation training with aerobic exercise and lifestyle modification
Participants in this group will practice autogenic relaxation training with aerobic exercise and lifestyle modification. The Intervention will last for 8 weeks, with autogenic relaxation training sessions conducted one time per week under physiotherapist's supervision. In addition, aerobic exercise will be three sessions per week for 8 weeks.
干预措施: Aerobic exercises (Other)
Autogenic relaxation training with aerobic exercise and lifestyle modification
Participants in this group will practice autogenic relaxation training with aerobic exercise and lifestyle modification. The Intervention will last for 8 weeks, with autogenic relaxation training sessions conducted one time per week under physiotherapist's supervision. In addition, aerobic exercise will be three sessions per week for 8 weeks.
干预措施: Lifestyle modification (Other)
Aerobic exercise and lifestyle modification
Participants in this group will receive aerobic exercise and lifestyle modification. Aerobic exercise will be three sessions per week for 8 weeks.
干预措施: Aerobic exercises (Other)
Aerobic exercise and lifestyle modification
Participants in this group will receive aerobic exercise and lifestyle modification. Aerobic exercise will be three sessions per week for 8 weeks.
干预措施: Lifestyle modification (Other)
结局指标
主要结局
Irritable Bowel Syndrome Severity Scoring System
时间窗: 12 weeks
The IBS-SSS is a valid and reliable patient-based measure that evaluates the severity of IBS symptoms through five clinically significant items over ten days, as follows: (1) frequency and (2) severity of abdominal pain; (3) degree of abdominal distention or tightness; (4) dissatisfaction with bowel habits; and (5) affection of IBS on quality of life. A greater score denotes worse conditions. Each item is rated on a visual analog scale (VAS) from 0 to 100, resulting in an overall score ranging from 0 to 500. Based on the data collected, the IBS-SSS scores are divided into three categories: mild symptoms (from 75 to 174), moderate symptoms (from 175 to 299), and severe symptoms (from 300 to 500). Additionally, a 95-point reduction in total IBS-SSS scores is clinically meaningful, indicating an improvement in symptoms.
Frequency of complete spontaneous bowel movements
时间窗: 12 weeks
Complete spontaneous bowel movement is defined as a sense of complete evacuation without laxatives, enemas, or suppositories on the day of the bowel movement or the preceding day. A participant with a weekly complete spontaneous bowel movement frequency rate of three or more and an increase of one or more from baseline is considered a responder. The patients reported the number of their complete spontaneous bowel movements per week at baseline, post-intervention and one month later. The minimal clinically important change in the number of complete spontaneous bowel movements is 1.3 times per week.
Modified Fatigue Impact Scale (MFIS)
时间窗: 12 weeks
The Arabic version of the questionnaire will be used. The 21 items in the MFIS are divided into three categories: physical (nine items), cognitive (10 items), and psychosocial (two items). For all items, participants rate their agreement using a 5-point Likert scale, where 0 means "never" and 4 means "almost always." The total score (0-84) comprises sub-scores for physical (0-36), cognitive (0-40), and psychosocial (0-8) functioning. A greater score is worse.
The Hospital Anxiety and Depression Scale (HADS)
时间窗: 12 weeks
To evaluate anxiety and depression, the Arabic version of the Hospital Anxiety and Depression Scale (HADS) will be used. The Arabic version of HADS is a valid and reliable instrument. HADS has two subscales (i.e., anxiety and depression), and each subscale has 7 items. Each item is rated on a 4-point Likert scale (0-3). Each subscale has a normal range of 0-7, a borderline range of 8-10, and a range denoting depression or anxiety of 11-21. The minimal clinically important change is 1.17-2.13 for anxiety symptoms and 1.48-2.54 for depression symptoms.
Assessment of Quality of Life
时间窗: 12 weeks
Thirty-Six-Item Short Form Health Survey (SF36) will be used. This scale is designed to measure disease burden and to assess the patients' QOL as a reflection of their health condition. It includes 36 items that assess many aspects, including physical functioning, role restrictions due to physical or emotional health problems, energy/fatigue, emotional wellbeing, social functioning, bodily pain, and general health perceptions. The scoring system ranges from 0 (representing the poorest health status) to 100 (indicating an optimal health state).
Estimation of cortisol level
时间窗: 12 weeks
The woman will be asked to lie in half lying position, with well supported back and arms. The antecubital area will be cleaned with alcohol. Blood sample of about 5cm will be drawn from the antecubital vein from all subjects by disposable sterile syringe by venipuncture to determine the plasma cortisol level. This will be done three times, before starting treatment, after the end of sessions and after one month as follow-up.
次要结局
未报告次要终点
研究者
Nisreen Ashraf
Principal investigator
Cairo University
