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IRCT20190602043790N3 IRCT 2024-02-02 Bagheiat-allah University of Medical Sciences Effectiveness of Neurofeedback on psychological stress Evaluation of the effectiveness of Neurofeedback on psychological stress; salivary cortisol and α-amylase level in college students 2021-08-06 anticipated 60 Complete https://irct.ir/trial/57463 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants are randomly allocated to the two groups by a table of random numbers. Each participant is given a number from 1 to n and using the table of random numbers, patients are randomly divided into two groups: control or Neurofeedback, Blinding description: Psychiatrist and data analysts do not know how patients are assigned, but participants in the trial know which group they belong to. N/A Condition 1: Anxiety. Condition 2: stress. Intervention 1: Control group: Participants do not receive intervention during the 12 weeks. Intervention 2: Intervention group: Participants receive 2 30-minute neurofeedback training session (The EEG signals using the BioGraph Infinity EEG Suite SA7950 Software) undergoes a series of recording, processing, filtering, and representation procedures. This software amplifies the amplitude of the frequency bands, while the hardware Pro Comp 2 Infinity (Thought Technology Ltb; Montreal, Quebec) transmite the signal to the computer. The EEG serves both as a means of recording and as a source for feedback, with a sampling rate of 256 Hz samples/second, and the data was redirect to the computer via an A/D converter) every week for 10 weeks. Yes - There is a plan to make this available What will be shared: Only part of the data, such as information related to main outcome or like that , can be shared When: Start of access, 6 months after publishing the results To whom: Only people working in academic institutions could apply. Conditions: People who intend to do clinical trials in this field can apply. Where to obtain: By referring to the email address s.hasanvandi@alzahra.ac.ir How to obtain: The applicant can receive information by registering the exact personal details and sending it via email. Comments:
public Saba Hasanvandi
Sheykhbahaie street, Molla Sadra street, Vanak square, Tehran
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8804 0060 s.hasanvandi@alzahra.ac.ir Bagheiat-allah University of Medical Sciences scientific Dr Saba Hasnvandi
Sheykhbahaie street, Molla Sadra street, Vanak square, Tehran
Tehran Iran (Islamic Republic of) 1435915371 +98 21 8804 0060 s.hasanvandi@alzahra.ac.ir Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Achieving a score above 18 on the stress scale of the Stress, Anxiety and Depression Questionnaire (DASS-21) Age range between 18 to 25 years old 18 years 25 years Both Presence or history of severe psychiatric disorders (including periods of severe depression, anxiety disorders, substance use disorders) Smoking and psychedelic pills Using psychiatric drugs Epilepsy Various cardiovascular and respiratory disorders and blood pressure Aspirin use and acetaminophen over the past 48 hours history of cancer diabetes hypothyroidism or hyperthyroidism Addison disease Cushing's syndrome hypertension Use of corticosteroids and steroids F06.4 F43.0 Anxiety disorder due to known physiological condition Acute stress reaction Behavior Treatment - Devices Control group: Participants do not receive intervention during the 12 weeks Intervention group: Participants receive 2 30-minute neurofeedback training session (The EEG signals using the BioGraph Infinity EEG Suite SA7950 Software) undergoes a series of recording, processing, filtering, and representation procedures. This software amplifies the amplitude of the frequency bands, while the hardware Pro Comp 2 Infinity (Thought Technology Ltb; Montreal, Quebec) transmite the signal to the computer. The EEG serves both as a means of recording and as a source for feedback, with a sampling rate of 256 Hz samples/second, and the data was redirect to the computer via an A/D converter) every week for 10 weeks. Anxiety symptoms. Timepoint: At the beginning of the study (before the intervention), weeks 5 and 10 after the start of neurofeedback in intervention group. Method of measurement: Stress, anxiety and depression scales (DASS-21). Stress. Timepoint: At the beginning of the study (before the intervention), weeks 5 and 10 after the start of neurofeedback in intervention group. Method of measurement: Stress, anxiety and depression scales (DASS-21). Cortisol. Timepoint: At the beginning of the study (before the intervention), weeks 5 and 10 after the start of neurofeedback in intervention group. Method of measurement: Stress, anxiety and depression scales (DASS-21). α amylase. Timepoint: At the beginning of the study (before the intervention), weeks 5 and 10 after the start of neurofeedback in intervention group. Method of measurement: Stress, anxiety and depression scales (DASS-21). Bagheiat-allah University of Medical Sciences Approved 2020-05-05 Ethics Committee of Baqiyatallah University of Medical Science Sheykhbahaie street, Molla Sadra street, Vanak square, Tehran Tehran Tehran Iran (Islamic Republic of)