Protocol summary

Study aim
The aim of this Study is to determine how effective the use of tDCS can be in Improving Processing Speed؛ life Satisfaction؛ Depression؛ Anxiety؛ Stress and Sleep Quality in Students.
Design
This trial has a control group, double-blind, randomized, on 30 students per day with sleep problems, and SPSS-24 software is used for analysis.
Settings and conduct
This work was done in the cognitive science lab of the university and for 10 sessions (20min) in two experimental and control groups, and the participants and the clinical supervisor did not know about the type of intervention.
Participants/Inclusion and exclusion criteria
The research population is all students of Shahid Bahonar uk , who are at a low level in terms of sleep quality, and the Entry criteria are as follows: Having Problems With the Quality of Sleep and Being Dissatisfied With Its Quality in the Last Month؛ Having Sleep Mode While Driving and Daily Tasks؛ The Sample Must be From The Student Community؛ Having Depression, Anxiety, Stress؛ Having Problems in Some Executive Functions, Including Processing Speed.The exit criteria are as follows: Having a History of Brain Injury or Seizures؛Having a History of Bipolar Disorders or Psychotic Disorders؛ Having Acute Suicidal Thoughts؛ Taking Psychiatric Drugs at The Time of The Study؛؛ Being Pregnant؛ Having Metal, Prostheses,Implants and The Presence of Batteries in the Heart؛ History of Neurological Diseases؛ Serious Medical Diseases (Heart Problems, Respiratory Failure)؛ Attention Problems؛ Memory Problems
Intervention groups
The Intervention in the Experimental Group was applied in the form of 20 min of Stimulation of the F3 and F4 area, but in the control group, in the form of 30 seconds of stimulation from 20 min of stimulation and the rest of the time the device was turned off.
Main outcome variables
Processing Speed؛ life Satisfaction؛ Depression؛ Anxiety؛ Stress؛ Sleep

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221211056780N1
Registration date: 2023-07-11, 1402/04/20
Registration timing: retrospective

Last update: 2023-07-11, 1402/04/20
Update count: 0
Registration date
2023-07-11, 1402/04/20
Registrant information
Name
Hamid Reza Dehghan
Name of organization / entity
Shahid Bahonar University of Kerman
Country
Iran (Islamic Republic of)
Phone
+98 31 3274 1025
Email address
h.dehghan@ens.uk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-14, 1401/11/25
Expected recruitment end date
2023-05-15, 1402/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Transcranial Direct Current Stimulation (tDCS) Treatment on Processing Speed, Life Satisfaction, Negative Emotional States in Students With Poor Sleep Quality
Public title
The Effect of Transcranial Direct Current Stimulation (tDCS) Treatment on Processing Speed, Life Satisfaction, Negative Emotional States in Students With Poor Sleep Quality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having Problems With the Quality of Sleep and Being Dissatisfied With Its Quality in the Last Month Having Sleep Mode While Driving and Daily Tasks The Sample Must be From The Student Community Having Depression, Anxiety, Stress Having Problems in Some Executive Functions, Including Processing Speed
Exclusion criteria:
Having a History of Brain Injury or Seizures Having a History of Bipolar Disorders or Psychotic Disorders Having Acute Suicidal Thoughts Taking Psychiatric Drugs at The Time of The Study (Anti -Depressants, Anti-Psychotics, Anti-Anxiety Drugs, Sedatives and Benzodiazepines) Dependence on Alcohol or Drugs or Psychoactive Substances Being Pregnant Having Metal, Prostheses,Implants and The Presence of Batteries in the Heart History of Neurological Diseases (Stroke, etc.) Serious Medical Diseases (Heart Problems, Respiratory Failure, Various Malignancies) Attention Problems Memory Problems
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the simple randomization method is used to implement the randomization method, and the randomization was done individually, and it is in this way that for the implementation of simple randomization, a table of random numbers is used, and the subjects must be a similar pair. Use in groups. In contrast, according to the score they get from the Pittsburgh Sleep Quality Questionnaire, they can't. After that, the subjects are placed in a table of random numbers from 1 to 30, so any test that can be chosen randomly. The control group is placed. Also, the method of concealment is such that, as an important clinical activity in the laboratory, it can determine which of these subjects are in the intervention group and which are in the control group, and each subject who is in the control group is known. Is. with the subject who is in the experimental group under the same conditions.
Blinding (investigator's opinion)
Double blinded
Blinding description
Considering that there are two groups (Experimental Group and Control Group) in this study, the participants in the experimental or control group were kept blind, so that they were treated with direct electrical stimulation for 20 minutes, but in the group Placebo is a fake treatment, that is, only 30 seconds of electrical stimulation is done in 20 minutes to get a feeling similar to the real treatment, and also both groups are intervened in exactly the same conditions so that the clinical supervisor does not realize that the subject in which group (Intervention or Placebo) and only the researcher and project implementers are aware of this issue, but all participants are fully aware that they are participating in a study and have been fully informed of this type of treatment and its conditions and have expressed their satisfaction.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics committees of Kerman University of Medical Sciences
Street address
Shahid Bahonar University of Kerman, Pajoohesh Sq, Imam Khomeni Highway,Kerman,I.R Iran
City
kerman
Province
Kerman
Postal code
7616913439
Approval date
2023-06-06, 1402/03/16
Ethics committee reference number
IR.KMU.REC.1402.087

Health conditions studied

1

Description of health condition studied
Poor Sleep Quality
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified

Primary outcomes

1

Description
Processing Speed
Timepoint
Before an Intervention and Ten Days After an Intervention.
Method of measurement
Wechsler Coding Test of Adult Intelligence (Revised)

2

Description
Life Satisfaction
Timepoint
Before an Intervention and Ten Days After an Intervention.
Method of measurement
Diener Life Satisfaction Scale

3

Description
Negative Emotional States
Timepoint
Before an Intervention and Ten Days After an Intervention
Method of measurement
Depression, Anxity, Stress Scale _ 21 Question

4

Description
Sleep
Timepoint
Before an Intervention and Ten Days After an Intervention
Method of measurement
Pittsburgh Sleep Quality Index

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:In this Group, Subjects were Subjected to Transcranial Direct Current Stimulation of the Brain (tDCS).In this Study, Electrical Stimulation With Direct Electric Current was used based on the F3/F4 Protocol, According to the System of 10-20 Brain Regions, the F3 Region was Anodicly Stimulated and the F4 Region was Cathodically Inhibited.Stimulation was done up to 2 mA and automatically turned off after 20 minutes.
Category
Treatment - Devices

2

Description
Control group:In this Group, Subjects were subjected to Transcranial Direct Current Stimulation.In this Study, stimulation with Direct Electric Current was used based on the F3 and F4 protocol, According to the System of 10-20 brain regions, the F3 region was Anodicly stimulated and the F4 region was Cathodically inhibited, and the stimulation was performed up to 2 mA and then It was automatically turned off after 30 seconds.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Bahonar University of Kerman
Full name of responsible person
Hamid Reza Dehghan
Street address
Shahid Bahonar University of Kerman, Pajoohesh Sq, Imam Khomeni Highway,Kerman,I.R Iran
City
kerman
Province
Kerman
Postal code
7616913439
Phone
+98 913 025 6226
Email
h.dehghan@ens.uk.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Bahonar University of Kerman
Full name of responsible person
Ali Reza Saidi
Street address
Shahid Bahonar University of Kerman, Pajoohesh Sq, Imam Khomeni Highway,Kerman,I.R Iran
City
kerman
Province
Kerman
Postal code
7616913439
Phone
+98 913 025 6226
Email
h.dehghan@ens.uk.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Bahonar University of Kerman
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
Shahid Bahonar University of Kerman
Full name of responsible person
Sayyed Mohammad Hossein Mousavi Nasab
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Bahonar University of Kerman, Pajoohesh Sq, Imam Khomeni Highway,Kerman,I.R Iran
City
kerman
Province
Kerman
Postal code
7616913439
Phone
+98 34 3132 2425
Email
hossein.mousavi-nasab@uk.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Bahonar University of Kerman
Full name of responsible person
Hamid Reza Dehghan
Position
Master student of clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Shahid Bahonar University of Kerman, Pajoohesh Sq, Imam Khomeni Highway,Kerman,I.R Iran
City
kerman
Province
Kerman
Postal code
7616913439
Phone
+98 31 3274 1025
Email
h.dehghan@ens.uk.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Bahonar University of Kerman
Full name of responsible person
Hamid Reza Dehghan
Position
Master student of clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Shahid Bahonar University of Kerman, Pajoohesh Sq, Imam Khomeni Highway,Kerman,I.R Iran
City
kerman
Province
Kerman
Postal code
7616913439
Phone
+98 31 3274 1025
Email
h.dehghan@ens.uk.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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
Only documents related to the main variables of the study are shared. The personal information of the participants is confidential.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
After printing the results of all researchers in educational sciences and psychology, psychiatrists and neuroscience researchers and other fields can use the documents.
Under which criteria data/document could be used
Any analysis of the data is allowed only with the permission of the organizers of the project and Shahid Bahonar University of Kerman, Faculty of Humanities, Department of Psychology.
From where data/document is obtainable
Shahid Bahonar University of Kerman, postal code 7616913439 Respondents: 1- Dr. Seyyed Mohammad Hossein Mousavi Nesab, Head of Psychology Department Contact number: 03431322425 Email: hossein.mousavi-nasab@uk.ac.ir 2- Dr. Mahshid, experience, vice-chancellor of the faculty Email: m.tajrobehkar@uk.ac.ir Contact number: 09193207522 3- Hamid Reza Dehghan Email: h.dehghan@ens.uk.ac.ir Contact number: 09130256226
What processes are involved for a request to access data/document
6 months after the results are published
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