Irritable Bowel SyndromeNCT07533500
Effect of Autogenic Relaxation Training on Irritable Bowel Syndrome In Adult Females
A study testing Autogenic relaxation training, Aerobic exercises and Lifestyle modification in people with Irritable Bowel Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to determine the effect of autogenic relaxation training on irritable bowel syndrome in adult females. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Autogenic relaxation training, Aerobic exercises and Lifestyle modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Apr 2026to 10 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with irritable bowel syndrome (IBS) based on Rome IV diagnostic criteria constipation- predominant IBS.
- Their body mass index 25- 30.
Who cannot join
- Organic gastrointestinal disorder, thyroid dysfunction, respiratory, renal, hepatic disorder.
- Pregnancy, hematological disease, neurological and psychiatric disease.
- Previous history of stomach or intestinal excision.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study will be conducted to determine the effect of autogenic relaxation training on irritable bowel syndrome in adult females.
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Autogenic relaxation training, Aerobic exercises, Lifestyle modification
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenic relaxation trainingOther
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 exercisesOther
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 modificationOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Autogenic relaxation training; Other: Aerobic exercises; Other: Lifestyle modification |
| 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. Receives: Other: Aerobic exercises; Other: Lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion20 Aug 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisreen Ashraf, Cairo University
- Investigators
- Hossam Kamel, Professor, Study director, Al-Azhar Universitykhadyga Abdul Aziz, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533500
- Sponsor's protocol ID
- P.T.REC/012/006320
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Autogenic Relaxation Training on Irritable Bowel Syndrome In Adult Females
- ClinicalTrials.gov ID
- NCT07533500
- Acronym / sponsor ID
- P.T.REC/012/006320
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autogenic relaxation training with aerobic exercise and lifestyle modification | Experimental | Other: Autogenic relaxation training, Other: Aerobic exercises, Other: Lifestyle modificationParticipants 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. |
| Aerobic exercise and lifestyle modification | Active comparator | Other: Aerobic exercises, Other: Lifestyle modificationParticipants in this group will receive aerobic exercise and lifestyle modification. Aerobic exercise will be three sessions per week for 8 weeks. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients diagnosed with irritable bowel syndrome (IBS) based on Rome IV diagnostic criteria constipation- predominant IBS.
- Their body mass index 25- 30.
Key exclusion criteria (3 listed)
- Organic gastrointestinal disorder, thyroid dysfunction, respiratory, renal, hepatic disorder.
- Pregnancy, hematological disease, neurological and psychiatric disease.
- Previous history of stomach or intestinal excision.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autogenic relaxation trainingThe 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 | Autogenic relaxation training with aerobic exercise and lifestyle modification |
| Aerobic exercisesAll 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 | Aerobic exercise and lifestyle modification, Autogenic relaxation training with aerobic exercise and lifestyle modification |
| Lifestyle modificationPatients 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. | Other | Aerobic exercise and lifestyle modification, Autogenic relaxation training with aerobic exercise and lifestyle modification |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hossam Kamel, Professor study director
Al-Azhar University
khadyga Abdul Aziz, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autogenic relaxation training, Aerobic exercises and Lifestyle modification in people with Irritable Bowel Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nisreen A Helmy, Master (01118617255, nichelmy93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irritable Bowel Syndrome Severity Scoring System (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.