Protocol summary

Study aim
The aim of the present study was to compassion the effectiveness of Transcranial Direct-Current Stimulation and cognitive therapy based on emotion regulation on attention, impulsivity and aggression of students with special learning disabilities (reading).
Design
The present research method was a quasi-experimental and comparative experiment in which a pre-test/post-test design with two experimental groups and one control group was used.
Settings and conduct
The study was done at Bozorgmehr counseling center.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having a learning disability; willingness to participate in the study; having moderate and higher intelligence; not suffering from other disorders. Non-inclusion criteria: Participate in other intervention programs at the same time.
Intervention groups
The first intervention group was exposed to direct ultrasonic electrical stimulation, and the second experimental group was exposed to cognitive therapy based on emotion regulation. The control group did not receive any treatment.
Main outcome variables
Attention; impulsivity; aggression.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200430047252N1
Registration date: 2020-07-27, 1399/05/06
Registration timing: retrospective

Last update: 2020-07-27, 1399/05/06
Update count: 0
Registration date
2020-07-27, 1399/05/06
Registrant information
Name
Haniyeh Gholamzade nikjoo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3328 2541
Email address
hgholamzade23@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2020-01-10, 1398/10/20
Trial completion date
2020-02-20, 1398/12/01
Scientific title
The Effectiveness of Transracial Direct Current Stimulation on Attention, Impulsivity and Aggression of Students with Special Learning Disabilities (Reading)
Public title
Transracial Direct Current Stimulation on Attention, Impulsivity and Aggression of Students with Special Learning Disabilities.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having reading learning disability Willingness to participate in the study Having moderate and higher intelligence Not suffering from other disorders
Exclusion criteria:
Participate in other intervention programs at the same time.
Age
From 10 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
Actual sample size reached: 64
Randomization (investigator's opinion)
Randomized
Randomization description
36 students with special learning disabilities were randomly selected and then completely randomly (based on lottery) were divided into two groups of 18 experiments and controls. Allocation was done through drawing a code in which every student was given a code and we put the codes in a container. Then 18 codes which were first taken out would be allocated to experimental group and other codes would be allocated to control group.
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
Tabriz University of Medical Sciences
Street address
Department of Psychology and Educational Sciences, Teachers' room, Daneshgah street, East side of Pasdaran highway
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Approval date
2019-12-27, 1398/10/06
Ethics committee reference number
IR.IAU.TABRIZ.REC.1398.106

Health conditions studied

1

Description of health condition studied
Specific Learning Disabilities
ICD-10 code
F81.0
ICD-10 code description
Specific reading disorder

Primary outcomes

1

Description
Attention
Timepoint
Before and after the intervention
Method of measurement
questionnaire

2

Description
Impulsivity
Timepoint
Before and after the intervention
Method of measurement
questionnaire

3

Description
aggression
Timepoint
Before and after the intervention
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Transcranial Direct-Current Stimulation (tDCS) is a technique used to modify and modify brain function, which is now used as a healthy and effective procedure to treat most neurological conditions and even in medicine. Electrical Stimulation Technique A neural modification method that transmits electric current to a specific point in the skull over a very specific period of time, including an anode electrode that stimulates the nervous system and a cathode electrode that inhibits the nervous system. To stimulate the centers of the prefrontal cortex, this is responsible for controlling the complex movements of the anode electrode on the prefrontal cortex and the cathode electrode on the opposite shoulder (according to the 10-20 EEG system). Participants sit in a comfortable chair in a quiet room with no other sensory stimuli. Electrical stimulation of the brain by tDCS (Canadian-made Mind-Alif brand device) was instilled in students in a steady stream with a constant current of between 1.5 and 2 mA (intensity appropriate for client tolerance). Every other day and for 10 days, using a pair of 5×5 cm rubber electrodes covered with artificial sponge soaked in a normal saline solution and placed in the desired areas.
Category
Treatment - Other

2

Description
Control group: They did not receive any treatment.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Bozorgmehr Counseling Center
Full name of responsible person
Seyed Mahmoud Tabatabaei
Street address
Bozorgmehr Counseling Center, in front of District 2 of Education department, 17 Shahrivar Jadid street
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 41 3328 0605
Email
hgholamzade23@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hassan Rasouli Saghai
Street address
Department of Psychology and Educational Sciences, Teachers' Room, University Street, East side of Pasdaran Highway
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 41 3328 4562
Email
hgholamzade23@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
10
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
Islamic Azad University
Full name of responsible person
Haniyeh Gholamzade Nikjoo
Position
Department of Psychology, Tabriz Branch, Islamic Azad University, Tabriz, Iran.
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Department of Psychology and Educational Sciences, Teachers' room, Daneshgah street, East side of Pasdaran highway
City
Tabriz
Province
East Azarbaijan
Postal code
5156987663
Phone
+98 914 432 4633
Email
hgholamzade23@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Marziyeh Alivandi Vafa
Position
Department of Psychology, Tabriz Branch, Islamic Azad University, Tabriz, Iran.
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Psychology and Educational Sciences, Teachers' room, Daneshgah street, East side of Pasdaran highway
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Phone
+98 914 432 4633
Email
hgholaMZADE23@YAHOO.COM

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Marziyeh Alivandi Vafa
Position
Department of Psychology, Tabriz Branch, Islamic Azad University, Tabriz, Iran.
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Psychology and Educational Sciences, Teachers' room, Daneshgah street, East side of Pasdaran highway
City
TABRIZ
Province
East Azarbaijan
Postal code
5157944533
Phone
009891443246633
Email
hgholamzade23@yahoo.com

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
There is no need to publish data. Only the results of the survey will be published in the form of data reports
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
---
When the data will become available and for how long
--
To whom data/document is available
-
Under which criteria data/document could be used
---
From where data/document is obtainable
----
What processes are involved for a request to access data/document
---
Comments
---
Loading...