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Clinical Trials/NCT07533500
NCT07533500Not yet recruitingNot Applicable

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

Cairo University1 site in 1 country44 target enrollmentStarted: April 20, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
44
Locations
1
Primary Endpoint
Irritable Bowel Syndrome Severity Scoring System

Study Overview

Brief Summary

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Autogenic relaxation training with aerobic exercise and lifestyle modification

Experimental

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.

Intervention: Autogenic relaxation training (Other)

Autogenic relaxation training with aerobic exercise and lifestyle modification

Experimental

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.

Intervention: Aerobic exercises (Other)

Autogenic relaxation training with aerobic exercise and lifestyle modification

Experimental

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.

Intervention: Lifestyle modification (Other)

Aerobic exercise and lifestyle modification

Active Comparator

Participants in this group will receive aerobic exercise and lifestyle modification. Aerobic exercise will be three sessions per week for 8 weeks.

Intervention: Aerobic exercises (Other)

Aerobic exercise and lifestyle modification

Active Comparator

Participants in this group will receive aerobic exercise and lifestyle modification. Aerobic exercise will be three sessions per week for 8 weeks.

Intervention: Lifestyle modification (Other)

Outcomes

Primary Outcomes

Irritable Bowel Syndrome Severity Scoring System

Time Frame: 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

Time Frame: 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)

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nisreen Ashraf

Principal investigator

Cairo University

Study Sites (1)

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