Effect of Autogenic Relaxation Training on Irritable Bowel Syndrome In Adult Females

Condition(s) studied

Investigational drug(s) / intervention(s)

Autogenic relaxation training: The six standard exercises in autogenic relaxation training cause the body to feel calm, warm, and heavy. Each exercise involves the patient lying down, focusing without any particular objective, and then using verbal cues and visual imagination to relax her body in a particular way. The woman relaxed in a half-lying position with a supported back and both arms relaxed at her sides during the eight-week autogenic relaxation training, which lasted 30-40 minutes, one session each week. The woman was advised to focus on her breathing and identify if it was shallow or rapid. Then start to visualize anything in her thoughts. This item should be easy for her to use and enjoyable.

Aerobic exercises: All participant in both groups will perform the treadmill exercises three times a week for eight weeks.The participants will walk on the treadmill in a slow speed for 5 min to warm-up. After that, they will increase their speed until they reach the target heart rate and maintain it for 20 min finally, they will walk on the treadmill for 5 min with a slow speed to cool-down.

Lifestyle modification: Patients in both groups will be instructed to follow dietary advice for 8 weeks. This includes Integrating a healthier eating habit, having food at the same time every day with regular intervals. Never eat too little or too much. Staying properly hydrated. Preventing processed, fatty, and spicy food. Limiting caffeine, carbonated, and alcoholic drinks. Limiting fiber intake to soluble fibers starts with a low dose and builds up gradually. Avoiding insoluble fibers, gas-producing foods like beans, and sweeteners. Awareness of dietary intolerance. An additional advice for increasing physical activity.

Study summary

This study will be conducted to determine the effect of autogenic relaxation training on irritable bowel syndrome in adult females.

Eligibility

Primary outcome measure(s)

• Irritable Bowel Syndrome Severity Scoring System — 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 — 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) — 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) — 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 — 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 — 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.

Trial sites (1)

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