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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-35
SponsorCairo University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with irritable bowel syndrome (IBS) based on Rome IV diagnostic criteria constipation- predominant IBS.

Disqualifiers

Organic gastrointestinal disorder, thyroid dysfunction, respiratory, renal, hepatic disorder.

Pregnancy, hematological disease, neurological and psychiatric disease.

Previous history of stomach or intestinal excision.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Autogenic relaxation training

    Other intervention

    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

    Other intervention

    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

    Other intervention

    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.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: Autogenic relaxation training with aerobic exercise and lifestyle modificationExperimental treatment 3 interventions
Group B: Aerobic exercise and lifestyle modificationActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Irritable Bowel Syndrome Severity Scoring System

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.

Time frame
12 weeks
2

Frequency of complete spontaneous bowel movements

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.

Time frame
12 weeks
3

Modified Fatigue Impact Scale (MFIS)

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.

Time frame
12 weeks
4

The Hospital Anxiety and Depression Scale (HADS)

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.

Time frame
12 weeks

Secondary outcomes

Other outcomes

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