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IRCT20191215045743N1 IRCT 2020-12-23 Esfahan University of Medical Sciences Evaluation of the effectiveness of neurofeedback on irritable bowel syndrome The effectiveness of neurofeedback on the severity of gastrointestinal symptoms, depression, anxiety, stress and quality of life in patients with irritable bowel syndrome (IBS) 2020-11-10 anticipated 45 Complete https://irct.ir/trial/48433 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. N/A Irritable Bowel Syndrom. Intervention 1: Intervention group: Neurofeedback:For the intervention group, the neurofeedback method is performed from the unipolar protocol of anxiety at point PZ and for the treatment of depression at point F3. Treatment plan include 20 sessions which is done three times a week. Intervention 2: Intervention group: Placebo (quasi-neurofeedback): for the placebo control group where 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.similar to intervention group, placebo Treatment plan include 20 sessions which is done three times a week. Intervention 3: Control group: Routine gastrointestinal medications:This group receives only routine gastrointestinal medication according to the opinion of the gastroenterologist. Simultaneous evaluation is performed before and after the intervention of the intervention groups. Yes - There is a plan to make this available What will be shared: Findings and data including the severity of gastrointestinal symptoms, anxiety, depression, stress and quality of life before and after the intervention can be shared. When: Access starts 4 months after the article is published To whom: Data and documentation are available to academic researchers and medical staff. Conditions: Citing the source and preserving the rights of the researchers in this study Where to obtain: Refer to the Vice Chancellor for Research, Isfahan University of Medical Sciences How to obtain: The applicant can write a letter to the Vice Chancellor for Research of Isfahan University of Medical Sciences and request to receive the file. With the coordination of the executors, the files will be provided to the applicant Comments:
public Amrollah Ebrahimi
Department of Health Psychology, Medicine School, Isfahan University of Medical Sciences, Hezarjirib Street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 9313 a_ebrahimi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Amrollah Ebrahimi
Unit 5, Niloufar Building, Varpshti Alley, Sharafuddin Alley West Shariati Street, Hakim Nezami Avenue
Isfahan Iran (Islamic Republic of) 8173955174 +98 31 3625 8818 amrollahebi@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Having diagnostic criteria for IBS based on Rome III criteria , all three types of IBS included: C, D and M kind age between 18 and 45 years education: at least second level at middle school degree 18 years 45 years Both patients who refused to participate in study positive Family history of colon cancer WBC, parasites and blood in the stool History of thyroid disorders and abnormal thyroid test, Patients with unstable weight loss, anemia and eosinophilia, rectosigmoid and abnormal scoping Having diagnostic Criteria of Severe psychiatric and neurological disorders based on psychiatrist diagnosis. Having bloody stools K58 Irritable bowel syndrome Treatment - Other Placebo Treatment - Drugs Intervention group: Neurofeedback:For the intervention group, the neurofeedback method is performed from the unipolar protocol of anxiety at point PZ and for the treatment of depression at point F3. Treatment plan include 20 sessions which is done three times a week. Intervention group: Placebo (quasi-neurofeedback): for the placebo control group where 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.similar to intervention group, placebo Treatment plan include 20 sessions which is done three times a week. Control group: Routine gastrointestinal medications:This group receives only routine gastrointestinal medication according to the opinion of the gastroenterologist. Simultaneous evaluation is performed before and after the intervention of the intervention groups. Severity of gastrointestinal symptoms of irritable bowel syndrome based on IBS Symptom Severity Questionnaire,Symptoms of depression, anxiety and stress based on the score in DASS-42,Quality of life based on score in IBS-QOL-34 questionnaire. Timepoint: Before the intervention, the severity of gastrointestinal symptoms, depression, anxiety, stress and quality of life are measured. The list of alpha and beta waves is saved after each session. At the end of the sessions, the rate of gastrointestinal symptoms, psychological symptoms and quality of life are measured. Method of measurement: IBS-SSS Intensity of Gastrointestinal Symptoms Questionnaire, DASS-42 Questionnaire - Quality of Life Assessment QOL-34. Record brain waves of alpha and beta waves. Esfahan University of Medical Sciences Approved 2020-11-04 Ethics committee of Isfahan University of medical Sciences Hezarjirib,Isfahan University of Medical Sciences ISFAHAN Isfehan Iran (Islamic Republic of)