Comparison of the effectiveness Transcranial Direct Current Stimulation with cognitive-behavior therapy on the test anxiety of first and second period of time high school students in Baladeh region
Determining the effectiveness Transcranial Direct Current Stimulation with cognitive-behavior therapy on the test anxiety of first and second period of time high school students
Design
Two arm parallel group randomized trial with a control group was performed on 45 high school students. Random number table was used for randomization.
Settings and conduct
The 45 students participating in the study will be randomly divided into three groups. Before and after the interventions in different groups, the level of students' test anxiety will be measured using the Friedman test anxiety questionnaire and statistical data will be collected.
Participants/Inclusion and exclusion criteria
participants:
The first and second period of time high school students in Baladeh region
inclusion criteria:
Written consent to participate in the research, Iranian nationality, living in Baladeh region, study in the first or second period of high school, nothing mental health problems leading to hospitalization of the student, not to be absent in cognitive-behavioral training sessions of test anxiety more than 4 sessions, observance of the rules of cognitive-behavioral training sessions of test anxiety
Intervention groups
Transcranial Direct Current Stimulation group: It is an instruction that is performed during 10 sessions and each session for 20 minutes and in a one-month interval by direct and weak electric current with the intensity of 2 mA stimulated by nerves through two electrodes located on their skulls.
Cognitive-behavioral therapy group: In the present study, cognitive-behavioral therapy means training that is performed as a group for 8 sessions, during 8 weeks and each treatment session lasts 60 minutes.
Control group: No intervention was performed in the students of the control group.
Main outcome variables
Reduce test anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190817044550N3
Registration date:2020-09-13, 1399/06/23
Registration timing:prospective
Last update:2020-09-13, 1399/06/23
Update count:0
Registration date
2020-09-13, 1399/06/23
Registrant information
Name
Mohammad Hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8950 2504
Email address
meditorha@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-03-05, 1399/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness Transcranial Direct Current Stimulation with cognitive-behavior therapy on the test anxiety of first and second period of time high school students in Baladeh region
Public title
Evaluation the effect of Transcranial Direct Current Stimulation and cognitive-behavior therapy on the test anxiety of high school students
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having the written consent to participate in the research
Iranian nationality
Living in Baladeh region
Study in the first or second period of high school
No mental health problems leading to hospitalization of the student
Not to be absent in cognitive-behavioral training sessions of test anxiety more than 4 sessions
Observance of the rules of cognitive-behavioral training sessions of test anxiety
Age between 11 and 18 years old
Exclusion criteria:
Reluctance to collaborate in the study
Having mental health problems while studying
Absence from cognitive-behavioral training sessions test anxiety more than 4 sessions
Age
From 11 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
We used the permuted block randomization method, and these blocks were randomly designed in Excel software, and then groups equal to the allocation of a as the intervention group and b as the control group were performed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Biomedical Research Ethics Committee, Islamic Azad University - Babol Branch
Street address
Babol Islamic Azad University, Three kilometers of Ghaemshahr Rd, Babol town, Mazandaran Province, Iran
City
Babol
Province
Mazandaran
Postal code
3738147471
Approval date
2020-08-26, 1399/06/05
Ethics committee reference number
IR.IAU.BABOL.REC.1399.028
Health conditions studied
1
Description of health condition studied
Test anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Friedman Test Anxiety Score
Timepoint
Before and after the intervention
Method of measurement
Using Friedman test Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: transcranial stimulation of the brain with direct current is an instruction that was performed during 10 sessions and each session for 20 minutes and in a one-month interval (with an interval of two days between sessions) by direct and weak electric current with the intensity of 2 mA stimulated by nerves through two electrodes located on their skulls.
Category
Behavior
2
Description
Second Intervention group: cognitive-behavioral therapy means training that is performed as a group for 8 sessions, during 8 weeks and each treatment session lasts 60 minutes.
Category
Behavior
3
Description
Control group: No intervention was performed in the students of the control group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Islamic Azad University
Full name of responsible person
Gholamali Nikpour
Street address
Babol Islamic Azad University, Three kilometers of Ghaemshahr Rd, Babol town, Mazandaran Province, Iran
City
Babol
Province
Mazandaran
Postal code
37381-47471
Phone
+98 11 3241 5000
Email
nikpoorg@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Gholamali Nikpour
Street address
Babol Islamic Azad University, Three kilometers of Ghaemshahr Rd, Babol town, Mazandaran Province, Iran
City
Babol
Province
Mazandaran
Postal code
37381-47471
Phone
+98 11 3241 5000
Email
nikpoorg@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Alireza Kargozar
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Babol Islamic Azad University, Three kilometers of Ghaemshahr Rd, Babol town, Mazandaran Province, Iran
City
Babol
Province
Mazandaran
Postal code
37381-47471
Phone
+98 11 3241 5000
Email
st.A.R.Kargozar@iauamol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Gholamali Nikpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Babol Islamic Azad University, Three kilometers of Ghaemshahr Rd, Babol town, Mazandaran Province, Iran
City
Babol
Province
Mazandaran
Postal code
37381-47471
Phone
+98 11 3241 5000
Email
nikpoorg@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza Kargozar
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Babol Islamic Azad University, Three kilometers of Ghaemshahr Rd, Babol town, Mazandaran Province, Iran
City
Babol
Province
Mazandaran
Postal code
37381-47471
Phone
+98 11 3241 5000
Email
st.A.R.Kargozar@iauamol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The data obtained from this project will eventually be reported as standard and general, and reporting personal information by individuals does not seem necessary.
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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Demographic information and information about the main outcome of this project can be shared.
When the data will become available and for how long
Start of access period 1 year after printing the results
To whom data/document is available
The data of this project can be shared by all aspiring researchers working in academic and scientific institutes.
Under which criteria data/document could be used
Appropriate scientific use of the data of this study in order to improve the quality of similar studies is unimpeded.
From where data/document is obtainable
The data of the present research is possible by announcing the request via email nikpoorg@yahoo.com and also st.A.R.Kargozar@iauamol.ac.ir.
What processes are involved for a request to access data/document
After confirming the eligibility of the person requesting the information, the data will be sent as soon as possible via the above emails.