The effectiveness of neurofeedback on the severity of gastrointestinal symptoms, depression, anxiety, stress and quality of life in patients with irritable bowel syndrome (IBS)

Determining the effectiveness of neurofeedback on the severity of gastrointestinal symptoms, Depression, Anxiety, Stress and Quality of life in patients with irritable bowel syndrome.

Clinical trial with double-blind, randomized, and parallel group design of 45 patients, random allocation rule type is used by lottery balls.

Clinical trial is performed in the Clinic of Gastrointestinal Functional Disorders with randomized double blind parallel groups. patients are not aware of the treatment of other group, Therapists are unaware of other groups treatment and assessment, and evaluators are unaware group types . patients are assessed by assessors for quality of life , IBS symptom severity, anxiety and depression. At the end of the course, all groups will be assessed .

Inclusion criteria :Having diagnostic full criteria of IBS based on Rome III criteria, age between 18 to 45 years. Non-inclusion criteria: dissatisfaction to participate , having bloody stools, family history of colon cancer, Unstable weight loss, anemia and eosinophilia, rectosigmoid, abnormal scoping, and concomitant psychiatric and neurological diseases

For the intervention group, neurofeedback method from the unipolar protocol of anxiety on the PZ point and for depression at point F3 will be done .for placebo group, the Active Electrodes are placed in the middle of the skull at point CZ and the Grand Electrode is attached to the softness of the patient's ear. The control group receives only routine gastrointestinal drug treatment.

Reduce the severity of gastrointestinal symptoms, reduce depression, anxiety, stress and increase quality of life In patients with irritable bowel syndrome.

Eligible participants include 45 people who are randomly assigned to three groups. Our method of randomization will be Random allocation rule that is a simple way of randomization. The randomization unit is the patient who is assigned to one of the groups A, B and C by the law of random allocation. In this way, the code of each person is recorded inside a lottery ball and is randomly removed from the container without any replacement and the created sequence is created. In this process, the person who assigns patients to the groups is not aware of the type of treatment groups. and does not know what intervention the next group is related to.

In this study, those who randomly assign participants to treatment groups do not know the nature of the groups. Therapists are also unaware of the type of treatment of other groups. Evaluators are also unaware of the type of groups.

Findings and data including the severity of gastrointestinal symptoms, anxiety, depression, stress and quality of life before and after the intervention can be shared.

Access starts 4 months after the article is published

Data and documentation are available to academic researchers and medical staff.

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