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IRCT20181013041327N3 IRCT 2023-04-13 Vice President of Research and Technology of Zanjan University Brain electrical stimulation and romantic relationship breakup Effectiveness of repeated transcranial electrical stimulation with direct current (tDCS) on the improvement of emotional distress and love trauma syndrome in students with romantic relationship breakup: a randomized clinical trial study with sham group 2023-04-21 anticipated 45 Complete https://irct.ir/trial/69398 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For small studies, random numbers can be used to sort individuals into groups. Persons participating in the research will be given a code or machine number in order to use the random or random numbers table. Since the number of people we want will be selected from 45 people, so the assigned codes and numbers will be double digits. To select sample people from the table, it will randomly start from a table point in the row or column direction. Subjects are then randomly assigned to one of tree study groups using the random number table and receive intervention in the same group, Blinding description: In this study, the participants will be blind to the type of stimulation received (fake or real). N/A love trauma syndrome. Intervention 1: Intervention group: Electrical stimulation of the dorsolateral prefrontal cortex (DLPFC) area with an intensity of 2 mA- 10 sessions, two sessions every day and the duration of providing stimulation for each session is 20 minutes. Intervention 2: Intervention group: Electrical stimulation of the Ventrolateral Prefrontal Cortex (VLPFC) area with an intensity of 2 mA- 0 sessions, two sessions every day and the duration of providing stimulation for each session is 20 minutes. Intervention 3: Control group: Mock stimulation of orsolateral prefrontal cortex (DLPFC)- 10 sessions, two sessions every day and duration of sham stimulation for each session is 20 minutes. Yes - There is a plan to make this available What will be shared: Behavioral data files, study protocols, informed consent forms, and clinical trial reports after identifiable individuals are shared. When: The access period starts 5 years after the results are published. To whom: Behavioral data for this study will only be available to researchers working in academic and scientific institutions Conditions: En Use of data is permitted only for articles related to the field of emotion. Where to obtain: Jaber Alizadehgoradel - j.alizadeh45@gmail.com How to obtain: Researchers who want to access the data should receive a letter from their workplace university and send it to the responsible person's email address, and the data will be available in less than 1 month. Comments:
public Jaber Alizadehgoradel
University of Zanjan, University Blvd., Zanjan
Zanjan Iran (Islamic Republic of) 4537138791 098243352441 j.alizadeh45@gmail.com The University of Zanjan scientific Jaber Alizadehgoradel
University of Zanjan, University Blvd., Zanjan
Zanjan Iran (Islamic Republic of) 3879145371 0098243354124 j.alizadeh45@gmail.com The University of Zanjan Iran (Islamic Republic of) Having love trauma syndrome The experience of failure in an emotional relationship during the last year Absence of psychiatric disorders 18 years no limit Both No previous history of neurological diseases, brain surgery, epilepsy, seizures, brain injury, head trauma or metal brain implants Diagnosis of depressive disorder, bipolar disorder, psychotic disorder or other psychiatric disorders based on DSM5 criteria F43.10 Post-traumatic stress disorder, unspecified Treatment - Other Treatment - Other Placebo Intervention group: Electrical stimulation of the dorsolateral prefrontal cortex (DLPFC) area with an intensity of 2 mA- 10 sessions, two sessions every day and the duration of providing stimulation for each session is 20 minutes Intervention group: Electrical stimulation of the Ventrolateral Prefrontal Cortex (VLPFC) area with an intensity of 2 mA- 0 sessions, two sessions every day and the duration of providing stimulation for each session is 20 minutes Control group: Mock stimulation of orsolateral prefrontal cortex (DLPFC)- 10 sessions, two sessions every day and duration of sham stimulation for each session is 20 minutes Love trauma syndrome. Timepoint: Before the intervention, after the intervention and one months after the intervention. Method of measurement: Love trauma syndrome Questionnaire. Emotion regulation. Timepoint: Before the intervention, after the intervention and one months after the intervention. Method of measurement: CANTAB Tset. Quality of Life. Timepoint: Before the intervention, after the intervention and one months after the intervention. Method of measurement: Quality of Life Questionnaire. Depression. Timepoint: Before the intervention, after the intervention and one months after the intervention. Method of measurement: Beck Depression Inventory. Anxiety. Timepoint: Before the intervention, after the intervention and one months after the intervention. Method of measurement: Beck Anxiety Inventory. Vice President of Research and Technology of Zanjan University Approved 2023-03-13 Ethics Committee of Zanjan University Zanjan, University Blvd, University of Zanjan Zanjan Zanjan Iran (Islamic Republic of)