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IRCT20221211056780N1 IRCT 2023-07-11 Shahid Bahonar University of Kerman The Effect of Transcranial Direct Current Stimulation (tDCS) Treatment on Processing Speed, Life Satisfaction, Negative Emotional States in Students With Poor Sleep Quality The Effect of Transcranial Direct Current Stimulation (tDCS) Treatment on Processing Speed, Life Satisfaction, Negative Emotional States in Students With Poor Sleep Quality 2023-02-14 anticipated 30 Complete https://irct.ir/trial/67393 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Poor Sleep Quality. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Only documents related to the main variables of the study are shared. The personal information of the participants is confidential. When: 6 months after the results are published To whom: After printing the results of all researchers in educational sciences and psychology, psychiatrists and neuroscience researchers and other fields can use the documents. Conditions: 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. Where to obtain: 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 How to obtain: 6 months after the results are published Comments:
public Sayyed Mohammad Hossein Mousavi Nasab
Shahid Bahonar University of Kerman, Pajoohesh Sq, Imam Khomeni Highway,Kerman,I.R Iran
kerman Iran (Islamic Republic of) 7616913439 +98 34 3132 2425 hossein.mousavi-nasab@uk.ac.ir Shahid Bahonar University of Kerman scientific Hamid Reza Dehghan
Shahid Bahonar University of Kerman, Pajoohesh Sq, Imam Khomeni Highway,Kerman,I.R Iran
kerman Iran (Islamic Republic of) 7616913439 +98 31 3274 1025 h.dehghan@ens.uk.ac.ir Shahid Bahonar University of Kerman Iran (Islamic Republic of) 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 18 years no limit Both 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 G47.9 Sleep disorder, unspecified Treatment - Devices Treatment - Devices 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. 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. Processing Speed. Timepoint: Before an Intervention and Ten Days After an Intervention. Method of measurement: Wechsler Coding Test of Adult Intelligence (Revised). Life Satisfaction. Timepoint: Before an Intervention and Ten Days After an Intervention. Method of measurement: Diener Life Satisfaction Scale. Negative Emotional States. Timepoint: Before an Intervention and Ten Days After an Intervention. Method of measurement: Depression, Anxity, Stress Scale _ 21 Question. Sleep. Timepoint: Before an Intervention and Ten Days After an Intervention. Method of measurement: Pittsburgh Sleep Quality Index. Shahid Bahonar University of Kerman Approved 2023-06-06 Research Ethics committees of Kerman University of Medical Sciences Shahid Bahonar University of Kerman, Pajoohesh Sq, Imam Khomeni Highway,Kerman,I.R Iran kerman Kerman Iran (Islamic Republic of)