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

This study purpose is to investigate the effectiveness of web-based training programs, self-hypnosis and bioenergy economy on awareness, quality of life, anxiety and depression and severity of symptoms in IBS patients

The randomized clinical trial, with two factorial groups, blinded outcome assessment, phase 3 on 120 patients, that were randomized by the Random Allocation Software

In this trial, 120 eligible patients were selected among referring cases to the gastroenterology and psychiatry clinics of Isfahan Al-Zahra hospital and will be randomly divided into 3 groups. All patients are assessed before and after training by standard relative questionnaires. The researcher assessing the outcomes will not be aware of randomization.

Inclusion Criteria: Diagnosis of moderate to severe IBS based on ROME III criteria and exclusion of potential organic causes by gastroenterology specialists Basic literacy skills Ability to work with and access software applications. Exclusion Criteria: Depression disorders, bipolar disorders, or psychotic disorders based on DSM-V diagnostic criteria Suicidal ideation or plans Antidepressant or antianxiety medications Participation in psychotherapeutic programs Pregnancy or breastfeeding History of bowel surgery Substance abuse

All participants undergo a 6-week training on various aspects of Irritable Bowel Syndrome (IBS). The first group, designated as the control group, receives only basic training. The second group, in addition to basic training, simultaneously undergoes Gut-Directed Hypnotherapy, through audio files and educational brochures. The third group, apart from basic training, also receives weekly training on bioenergy economics for IBS, using audio files and brochures.

Symptom severity, depression, anxiety, quality of life

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.

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.

All data can be shared after people have requested.

Six months after publishing the results

Academic researchers

Scientific uses

Isfahan University of Medical Sciences website

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