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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Other: Autogenic relaxation training; Other: Aerobic exercises; Other: Lifestyle modification

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nisreen A Helmy, Master; Phone Number: 01118617255; Email: nichelmy93@gmail.com
• Study Contact Backup: Name: Afaf Botla, Professor; Phone Number: 01223141816; Email: drafafmohamed@cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Nisreen Ashraf Helmy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Their body mass index 25- 30.

Exclusion Criteria:

• Organic gastrointestinal disorder, thyroid dysfunction, respiratory, renal, hepatic disorder.
• Pregnancy, hematological disease, neurological and psychiatric disease.
• Previous history of stomach or intestinal excision.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Other: 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.; Other: 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.
Active Comparator: 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.	Other: 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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks
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.	12 weeks
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.	12 weeks
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.	12 weeks
Assessment of Quality of Life	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).	12 weeks
Estimation of cortisol level	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.	12 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: khadyga Abdul Aziz, Professor, Cairo University; Study Director: Hossam Kamel, Professor, Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): September 10, 2026

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Mind-Body Therapies; Complementary Therapies; Psychotherapy; Behavioral Disciplines and Activities; Hypnosis; Exercise; Autogenic Training
• Other Study ID Numbers: P.T.REC/012/006320

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No