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IRCT20220727055566N1 IRCT 2022-12-20 Esfahan University of Medical Sciences Investigating the effect of direct electrical stimulation of the brain in improving anxiety, depression, quality of life and severity of symptoms in patients with irritable bowel syndrome The effect of trans cranial direct current stimulation (TDCS) intervention on improving anxiety, depression, quality of life, and severity of symptom in patients with moderate to severe irritable bowel syndrome under treatment 2022-10-22 anticipated 40 Complete https://irct.ir/trial/65178 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The people included in the study are randomly divided into intervention and control groups and we compare the effectiveness of the intervention before and immediately after and one month after the intervention between the two groups, Randomization description: Patients are randomly selected and divided into intervention and control groups by Random Allocation Software. The randomization unit is individual. Randomization was done by statistical software, Blinding description: One group is treated with electrical stimulation of the brain and the other group is treated with sham TDCS as a control. In this way, the location of the electrodes is the same, with the difference that to feel the initial itching, the current is only applied for the first 30 seconds and then it is cut off during the test. The evaluator only had the patient's code and had no knowledge of control or intervention. The data analyst also had the data in two separate groups, but did not know which of the groups were intervention or control. N/A Condition 1: Irritable Bowel Syndrome (IBS). Condition 2: Irritable Bowel Syndrome (IBS). Condition 3: Irritable Bowel Syndrome (IBS). Intervention 1: Intervention group: The intervention group is treated with electrical stimulation of the brain. The anode of the device is placed at the F3 place on the skull and the cathode is placed at the F4 place on the skull. The number of these treatment sessions is 5 daily and with an intensity of 2 amps, each treatment session lasts 30 minutes. Intervention 2: Control group: The control group of the TDCS device is placed on the skull. The anode of the device is placed at the F3 location on the skull and the cathode at the F4 location on the skull, and the current is applied only for the first 30 seconds, and then it is cut off during the test. The number of these sessions is considered to be 5 daily, each session lasting 30 minutes. Yes - There is a plan to make this available What will be shared: All study data will be shared after de-identification of study subjects. When: Access starts 6 months after results are published To whom: Researchers working in academic and scientific institutions Conditions: People who are looking to conduct scientific research can use the study data Where to obtain: Maedeh Rezaei Koujani Tel:00989103044525 Email: Maedeh.Rezaei48@gmail.com How to obtain: One week after the request, the requested data will be provided Comments:
public Maedeh Rezaei Koujani
No. 15, Vila Aley, Banafshe Miani Ave, Khane Esfahan Town
Esfahan Iran (Islamic Republic of) 8194819474 +98 31 3421 5356 maedeh.rezaei48@gmail.com Esfahan University of Medical Sciences scientific Maedeh Rezaei Koujani
No. 15, Vila Aley, Banafshe Miani Ave, Khane Esfahan Town
Esfahan Iran (Islamic Republic of) 8194819474 +98 31 3421 5356 maedeh.rezaei48@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Men and women aged 18 to 65 years Diagnosis of moderate and severe IBS disorder based on ROME III criteria by gastroenterologist Informed consent to participate in the study Having at least reading and writing literacy Living in the city of Isfahan 18 years 65 years Both Diagnosing any organic disease during the study that makes it impossible to continue participating in the study. Failure to visit on time to complete the treatment process Intolerance of the patient to therapy Willingness to withdraw from the study for any reason The existence of serious suicidal thoughts or plans Pregnancy or breastfeeding Substance use History of seizures Having a pacemaker Taking antidepressants and anti-anxiety drugs from 2 weeks ago K58.3 K58.1 K58.2 Irritable bowel syndrome with mixed bowel habits [IBS-M] Irritable bowel syndrome with predominant diarrhoea [IBS-D] Irritable bowel syndrome with predominant constipation [IBS-C] Treatment - Devices Treatment - Devices Intervention group: The intervention group is treated with electrical stimulation of the brain. The anode of the device is placed at the F3 place on the skull and the cathode is placed at the F4 place on the skull. The number of these treatment sessions is 5 daily and with an intensity of 2 amps, each treatment session lasts 30 minutes. Control group: The control group of the TDCS device is placed on the skull. The anode of the device is placed at the F3 location on the skull and the cathode at the F4 location on the skull, and the current is applied only for the first 30 seconds, and then it is cut off during the test. The number of these sessions is considered to be 5 daily, each session lasting 30 minutes. Depression score in Depression, Anxiety and Stress Scale questionnaire. Timepoint: Depression scores are measured before the start of the intervention, 5 days and 30 days after the start of the intervention. Method of measurement: Depression, Anxiety and Stress Scale is a 21-question self-report questionnaire that is a set of 3 scales designed with 14 questions to measure negative emotional states in depression, anxiety and stress. Anxiety score in Depression, Anxiety and Stress Scale questionnaire. Timepoint: Anxiety scores are measured before the start of the intervention, 5 days and 30 days after the start of the intervention. Method of measurement: Depression, Anxiety and Stress Scale is a 21-question self-report questionnaire that is a set of 3 scales designed with 14 questions to measure negative emotional states in depression, anxiety and stress. Stress score in Depression, Anxiety and Stress Scale questionnaire. Timepoint: Stress scores are measured before the start of the intervention, 5 days and 30 days after the start of the intervention. Method of measurement: Depression, Anxiety and Stress Scale is a 21-question self-report questionnaire that is a set of 3 scales designed with 14 questions to measure negative emotional states in depression, anxiety and stress. Irritable bowel syndrome symptom severity score in irritable bowel severity scoring system questionnaire. Timepoint: The time periods of measuring the severity score of irritable bowel syndrome symptoms are done before the intervention, 5 days and 30 days after the intervention. Method of measurement: The Irritable Bowel Severity Scoring System is a self-report questionnaire consisting of 5 sections that measures the severity of symptoms of irritable bowel syndrome, including pain, defecation disorder, bloating, the effect of the disease on daily life activities, and extraintestinal symptoms with a scale. Visual Analog Scale checks. Score of quality of life in Irritable Bowel Syndrome - Quality of Life questionnaire. Timepoint: The time periods for measuring the quality of life score in irritable bowel syndrome disease are performed before the intervention, 5 days and 30 days after the intervention. Method of measurement: The quality of life questionnaire for irritable bowel syndrome is a self-administered questionnaire with 34 questions that examines various aspects of the quality of life of people with irritable bowel syndrome. Esfahan University of Medical Sciences Approved 2020-10-18 Ethical Committee of Isfahan University of Medical Sciences No. 15, Banafshe Miani Ave, Khane Esfahan Town Esfahan Isfehan Iran (Islamic Republic of)