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IRCT20180205038630N3 IRCT 2019-01-16 Kermanshah University of Medical Sciences effect of theta binaural beat on primary insomniacs Study of the efficacy of theta binaural beat on the activity of brain waves in primary insomniacs 2019-01-21 anticipated 24 Complete https://irct.ir/trial/36419 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Primary insomnia. Intervention 1: Experimental group: Binaural beats are generated through Audacity software. The produced Binaural beat is at 6 Hz (theta) frequency. First, it is recorded for 5 minutes with closed eyes of the patient's brain waves through electroencephalography. Then, immediately for 15 minutes, with closed eyes, the theta binaural beat is heard through the headphones by the patient. In the final stage, the brain waves of the patient with closed eyes will be recorded for 5 minutes without receiving the binaural beat. For each patient, only one session is performed, which runs for the first 5 minutes as a pre-test, 15 second, post-test, and the last 5 minutes as follow-up. Intervention 2: Control group: White noise is a signal whose power density is the same at all frequencies. Such a sound will have all the audible frequencies of the same intensity. Therefore, they can be used as a placebo as in the research literature. First, it is recorded for 5 minutes with closed eyes of the patient's brain waves through electroencephalography. Then, immediately for 15 minutes, with closed eyes, the theta binaural beat is heard through the headphones by the patient. In the final stage, the brain waves of the patient with closed eyes will be recorded for 5 minutes without receiving the binaural beat. For each patient, only one session is performed, which runs for the first 5 minutes as a pre-test, 15 second, post-test, and the last 5 minutes as the follow-up. Yes - There is a plan to make this available What will be shared: IPD collected for the primary outcome measure only, When: Start the access period from 1398 To whom: only available for people working in academic institutions Conditions: After qualification, any activity is subject to the observance of ethical standards Where to obtain: amirpsy3@gmail.com Amir Bavafa +989158018060 Kermanshah, Parastar Blvd, Boostan enghelab dormity How to obtain: The request is sent via e-mail and the information is sent within 1 month. ٍEmail: amirpsy3@gmail.com Comments: I have no comments.
public Amir Bavafa
Parastar Blvd, boostan enghelab dormity
Kermanshah Iran (Islamic Republic of) 9186364357 +98 83 3836 7333 amirpsy3@gmail.com Kermanshah University of Medical Sciences scientific Ali Akbar Foroughi
Kermanshah university of medical science., medical school, Parastar Blvd
Kermanshah Iran (Islamic Republic of) 9186364357 +98 83 3837 4371 aliakbar.foroughi@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Informed consent and willingness to participate in research Evaluation of the index of insomnia severity index (ISI) at the clinical level (Score above 15) In order to enter the clinical interview Diagnosis of primary insomnia in a clinical interview by a psychiatrist The absence of severe neurological and psychiatric disorders Healthy physical and auditory condition No history of drug abuse Lack of cardiovascular problems Non-pregnant female participants Avoiding alcohol and drugs 12 hours before intervention 15 years no limit Both The annoying nature of the music used The occurrence of any physical and psychological warning signs such as headache Unwillingness to continue protocol of intervention by the patient Many artifacts during brain wave recordings, such as shaking or talking F51.0 Insomnia not due to a substance or known physiological condition Treatment - Other Placebo Experimental group: Binaural beats are generated through Audacity software. The produced Binaural beat is at 6 Hz (theta) frequency. First, it is recorded for 5 minutes with closed eyes of the patient's brain waves through electroencephalography. Then, immediately for 15 minutes, with closed eyes, the theta binaural beat is heard through the headphones by the patient. In the final stage, the brain waves of the patient with closed eyes will be recorded for 5 minutes without receiving the binaural beat. For each patient, only one session is performed, which runs for the first 5 minutes as a pre-test, 15 second, post-test, and the last 5 minutes as follow-up. Control group: White noise is a signal whose power density is the same at all frequencies. Such a sound will have all the audible frequencies of the same intensity. Therefore, they can be used as a placebo as in the research literature. First, it is recorded for 5 minutes with closed eyes of the patient's brain waves through electroencephalography. Then, immediately for 15 minutes, with closed eyes, the theta binaural beat is heard through the headphones by the patient. In the final stage, the brain waves of the patient with closed eyes will be recorded for 5 minutes without receiving the binaural beat. For each patient, only one session is performed, which runs for the first 5 minutes as a pre-test, 15 second, post-test, and the last 5 minutes as the follow-up. Brain wave pattern. Timepoint: Within 5 minutes before the intervention, 15 minutes during the intervention and 5 minutes later. Method of measurement: Electroencephalography (EEG). Kermanshah University of Medical Sciences Approved 2018-12-26 Ethics Committee of Kermanshah University of Medical Sciences Parastar Blvd, faculty of medicine Kermanshah Kermanshah Iran (Islamic Republic of)