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IRCT20190404043159N6 IRCT 2024-01-08 Esfahan University of Medical Sciences Impact of educational programs, self-hypnosis, and web-based bioenergy economics on patients with irritable bowel syndrome Comparative study of the impact of educational programs, self-hypnosis, and web-based bioenergy economics on the severity of symptoms, awareness, quality of life anxiety and depression in patients with irritable bowel syndrome 2024-01-21 anticipated 120 Complete https://irct.ir/trial/74562 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: In this study randomization performs based on the blocked randomization method. Information such as the number of study groups (3 main groups: 2 intervention groups (for example A,B) and a control group (for example (C), block size (a multiple of the number of groups that will be chosen in this study to reduce the complexity of the work, size 4) and the total number of patients (sample size 120 people), were enter into the online software machines specific for this calculation (for example available at https://www.sealedenvelope.com/simple-randomiser/v1/lists) and according to the codes that it is obtained by the final analysis (for example (group B 1, 4, 1), each of the patients being studied is given a specific code respectively. Blocking is usually used in order to create a balance in the number of samples assigned to each of the studied groups. In this method, equal blocking will be used. In this way, the samples are randomized in two groups as much as possible, Blinding description: One researcher performs randomization of individuals into three groups and then sets up the receipt of web-based programs. The second researcher, who is unaware of the group assignments, evaluates patients using the questionnaires. 3 Irritable bowel syndrome. Intervention 1: First intervention group: in addition to basic training, simultaneously undergoes Gut-Directed Hypnotherapy training, through audio files. These audio files include self-hypnosis training, which are recorded by the hypnotherapist and patients practice them at home between weekly sessions. According to the standard, the hypnotherapy process includes the following stages: induction, relaxation, deepening, therapeutic suggestions focused on the GI system, ego strengthening and emergence. Intervention 2: Second intervention group: apart from basic training, also receives weekly training on bio-energy economics for IBS, using audio files and brochures.These part include mental and behavioral, and motor techniques that reduce psychosomatic symptoms by regulating body movements and ergonomics and proportional distribution of biological energy. The 6-week IBS program is the abbreviated form of this program, which includes four sections relating to the body, thoughts, others, and existence. Intervention 3: Control group: undergo a 6-weeks basic training on various aspects of Irritable Bowel Syndrome (IBS) such as disease definition, signs and symptoms, diagnosis, lab tests, medical and non medical treatments, and prognosis. Yes - There is a plan to make this available What will be shared: All data can be shared after people have requested. When: Six months after publishing the results To whom: Academic researchers Conditions: Scientific uses Where to obtain: Isfahan University of Medical Sciences website How to obtain: Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data Comments:
public Mohammad Reza Sharbafchi
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0042 sharbafchi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Reza Sharbafchi
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0042 sharbafchi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Both male and female participants aged 18 to 65 years Diagnosis of moderate to severe IBS based on ROME III criteria and exclusion of potential organic causes by gastroenterology specialists Basic literacy skills (reading and writing) Ability to work with and access software applications Satisfaction to participate in the study 18 years 65 years Both Diagnosis of any organic disease during the study period that renders continued participation impossible Diagnosis of depression disorders, bipolar disorders, or psychotic disorders based on DSM-V diagnostic criterias assessed by a psychiatrist and psychiatric assistant Serious suicidal thoughts or plans at the time of study entry Use of antidepressant or antianxiety medications within 2 weeks prior to study entry Participation in psychotherapeutic programs within 2 months prior to study entry Pregnant or breastfeeding History of bowel surgery Substance abuse since the onset of symptoms K58 Irritable bowel syndrome Treatment - Other Treatment - Other Treatment - Other First intervention group: in addition to basic training, simultaneously undergoes Gut-Directed Hypnotherapy training, through audio files. These audio files include self-hypnosis training, which are recorded by the hypnotherapist and patients practice them at home between weekly sessions. According to the standard, the hypnotherapy process includes the following stages: induction, relaxation, deepening, therapeutic suggestions focused on the GI system, ego strengthening and emergence. Second intervention group: apart from basic training, also receives weekly training on bio-energy economics for IBS, using audio files and brochures.These part include mental and behavioral, and motor techniques that reduce psychosomatic symptoms by regulating body movements and ergonomics and proportional distribution of biological energy. The 6-week IBS program is the abbreviated form of this program, which includes four sections relating to the body, thoughts, others, and existence. Control group: undergo a 6-weeks basic training on various aspects of Irritable Bowel Syndrome (IBS) such as disease definition, signs and symptoms, diagnosis, lab tests, medical and non medical treatments, and prognosis. Severity of Irritable Bowel Syndrome symptoms. Timepoint: Before and after 6 weeks training. Method of measurement: The irritable bowel severity scoring system (IBSSS). Depression. Timepoint: Before and after 6 weeks training. Method of measurement: Hospital Anxiety and Depression Scale (HADS). Anxiety. Timepoint: Before and after 6 weeks training. Method of measurement: Hospital Anxiety and Depression Scale (HADS). Quality of life. Timepoint: Before and after 6 weeks training. Method of measurement: Irritable Bowel Syndrome Quality of Life (IBS-QOL-34). Awareness level. Timepoint: Before and after 6 weeks training. Method of measurement: Which number from 0 to 100 rates your awareness level of your disease?. Esfahan University of Medical Sciences Approved 2023-07-15 Ethics committee of Esfahan university of Medical sciences No. 18, Hezar Jarib Ave., Daneshgah Blvd., Isfahan Isfahan Isfehan Iran (Islamic Republic of)