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
• Determining and comparing the average anxiety score in the group receiving TDCS and the control group, before and after the intervention and one month after the end of the intervention.
• Determining and comparing the average score of depression in the group receiving TDCS and the control group, before and after the intervention and one month after the end of the intervention.
• Determining and comparing the average score of the quality of life in the group receiving TDCS and the control group, before and after the intervention and one month after the end of the intervention.
• Determining and comparing the mean score of symptom severity in the group receiving TDCS and the control group, before and after the intervention and one month after the end of the intervention.
Design
Clinical trial with two intervention and control groups, double blind and randomized on 40 patients. Statistical software is used for randomization
Settings and conduct
This study uses a double-blind (patient and evaluator) controlled randomized clinical trial. The study sample was selected from the patients referred to the psycho-physical clinic affiliated to Isfahan University of Medical Sciences in 1401.
Participants/Inclusion and exclusion criteria
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
Intervention groups
This study examines the effect of direct electrical stimulation of the brain in patients with moderate and severe irritable bowel syndrome who are undergoing standard IBS treatment.
Main outcome variables
anxiety score; depression score; quality of life score; IBS symptom severity score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220727055566N1
Registration date:2022-12-20, 1401/09/29
Registration timing:registered_while_recruiting
Last update:2022-12-20, 1401/09/29
Update count:0
Registration date
2022-12-20, 1401/09/29
Registrant information
Name
Maedeh Rezaei Koujani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3421 5356
Email address
maedeh.rezaei48@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-22, 1401/07/30
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
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.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
No. 15, Banafshe Miani Ave, Khane Esfahan Town
City
Esfahan
Province
Isfehan
Postal code
8194819474
Approval date
2020-10-18, 1399/07/27
Ethics committee reference number
IR.MUI.MED.REC.1399.637
Health conditions studied
1
Description of health condition studied
Irritable Bowel Syndrome (IBS)
ICD-10 code
K58.3
ICD-10 code description
Irritable bowel syndrome with mixed bowel habits [IBS-M]
2
Description of health condition studied
Irritable Bowel Syndrome (IBS)
ICD-10 code
K58.1
ICD-10 code description
Irritable bowel syndrome with predominant diarrhoea [IBS-D]
3
Description of health condition studied
Irritable Bowel Syndrome (IBS)
ICD-10 code
K58.2
ICD-10 code description
Irritable bowel syndrome with predominant constipation [IBS-C]
Primary outcomes
1
Description
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.
2
Description
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.
3
Description
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.
4
Description
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
5
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Azahra hospital of Esfahan, Psychosomatic clinic
Full name of responsible person
Fateme Sadat Naji
Street address
Soffe Blvd, Esfahan
City
Esfahan
Province
Isfehan
Postal code
8194819474
Phone
+98 31 3421 5356
Email
maedeh.rezaei48@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Daneshgah Blvd, Azadi Square
City
Esfahan
Province
Isfehan
Postal code
8194819474
Phone
+98 31 3792 8092
Email
dean@med.mui.ac.ir
Web page address
https://med.mui.ac.ir/fa/pajoheshi
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maedeh Rezaei Koujani
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No. 15, Vila Aley, Banafshe Miani Ave, Khane Esfahan Town
City
Esfahan
Province
Isfehan
Postal code
8194819474
Phone
+98 31 3421 5356
Email
maedeh.rezaei48@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maedeh Rezaei Koujani
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No. 15, Vila Aley, Banafshe Miani Ave, Khane Esfahan Town
City
Esfahan
Province
Isfehan
Postal code
8194819474
Phone
+98 31 3421 5356
Email
maedeh.rezaei48@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maedeh Rezaei Koujani
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No. 15, Vila Ave., Banafsheh Miani Blvd., Khane Esfahan Town
City
Esfahan
Province
Isfehan
Postal code
8194819474
Phone
+98 31 3421 5356
Fax
Email
maedeh.rezaei48@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All study data will be shared after de-identification of study subjects.
When the data will become available and for how long
Access starts 6 months after results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
People who are looking to conduct scientific research can use the study data