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IRCT20210314050703N3 IRCT 2023-07-07 Sanandaj University of Medical Sciences The effect of binaural sound waves on the level of anxiety, pain and vital signs of patients undergoing elective surgery with regional anesthesia The effect of binaural sound waves on the level of anxiety, pain and vital signs of patients undergoing elective surgery with regional anesthesia 2023-07-11 anticipated 150 Complete https://irct.ir/trial/70996 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, 150 patients undergoing elective surgery with regional anesthesia referred to Kawsar Sanandaj Medical Training Center were selected by controlled random sampling and divided into three control and intervention groups, binaural music and favorite music. By entering information on the site http://www.randomization.com, the main organizer of the project assigns a number to each sample, considering that headphones are placed for each of the 3 groups of patients, and the music corresponding to the number is given to the patient. Another researcher evaluates the anxiety and vital signs before and after the intervention without knowing about the intervention, and the analyst is not aware of the patient's information given that the numbers are given, Blinding description: This study is conducted in a double-blind way, so that 150 samples are divided into three equal groups of control and intervention of binaural music and favorite music. A number is assigned in each sample, considering that headphones are placed for each of the 3 groups of patients, the music corresponding to the number is given to the patient (the researcher does not know the results of the patient's assessment). and vital signs before and after (the researcher does not know which patient is the music group or the control) and the analyst does not know about the patient's information due to the fact that the numbers are given. N/A Anxiety. Intervention 1: Intervention group: binaural music, binaural sound waves are special musical interventions that have recently received attention among neuro physiologists and doctors as a therapeutic tool when two tones with different frequencies are sent to the brain from each ear. An interference is created which is called binaural sound waves. The frequencies of tones should be less than 1000 to 1500 Hz. The difference in frequencies is the same as binaural sound waves, which should be less than 30 Hz. At first, the patient is placed in a quiet environment for 10 minutes in the preparation of the operating room. Then binaural sound wave music will be played with headphones from 15 minutes before the surgery until the end of the surgery. Vital signs and anxiety are measured for the patient before, during and after the intervention. Intervention 2: Intervention group: favorite music based on the patient's favorite music style after 10 minutes of entering the preparation department in the operating room, is played with headphones for the patient from 15 minutes before the operation until the end of the operation. Intervention 3: Control group: No intervention, After 10 minutes of entering the preparation department in the operating room, headphones are played without any music for the patient from 15 minutes before the operation until the end of the operation. Yes - There is a plan to make this available What will be shared: Only publishable information that does not conflict with the principles of ethics in clinical trial research and informed consent and does not contain personal information of individuals will be published When: Starting the access period 6 months after printing the results" To whom: Only the people of the research team based on the principles specified in the research and the patients will be allowed to access their information at the specified level. Other researchers and people will have access without mentioning the details of the analyzed information Conditions: The ethics committee and legal authorities have the ability to access information according to the laws without mentioning the personal characteristics of individuals upon official request Where to obtain: To access publishable information, you can refer to the research system of Kurdistan University of Medical Sciences at http://rms.muk.ac.ir How to obtain: Access to the documents is after obtaining permission from the Research Vice-Chancellor of Kurdistan University of Medical Sciences with the coordination of the main researcher of the research Comments:
public Negin Ghadami
Kurdistan University of Medical Sciences, Faculty of Medical, Pasdaran St.
Sanandaj Iran (Islamic Republic of) 6618634683 +98 87 3322 9494 ghadaminegin@gmail.com Sanandaj University of Medical Sciences scientific Negin Ghadami
Kurdistan University of Medical Sciences, Faculty of Medical, Pasdaran St.
Sanandaj Iran (Islamic Republic of) 6618634683 +98 87 3322 9494 ghadaminegin@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Elective surgeries patient satisfaction conscious patients patients over 18 years old non-pregnant female patients healthy hearing 18 years no limit Both history of epilepsy uncontrollable anxiety in the patient history of chronic pain patient agitation ear infection use of anti-anxiety drugs drug r opioid addiction Alcohol consumption in the past 12 hours neurological and psychiatric disorders heart dysrhythmias F06.4 Anxiety disorder due to known physiological condition Treatment - Other Treatment - Other Treatment - Other Intervention group: binaural music, binaural sound waves are special musical interventions that have recently received attention among neuro physiologists and doctors as a therapeutic tool when two tones with different frequencies are sent to the brain from each ear. An interference is created which is called binaural sound waves. The frequencies of tones should be less than 1000 to 1500 Hz. The difference in frequencies is the same as binaural sound waves, which should be less than 30 Hz. At first, the patient is placed in a quiet environment for 10 minutes in the preparation of the operating room. Then binaural sound wave music will be played with headphones from 15 minutes before the surgery until the end of the surgery. Vital signs and anxiety are measured for the patient before, during and after the intervention Intervention group: favorite music based on the patient's favorite music style after 10 minutes of entering the preparation department in the operating room, is played with headphones for the patient from 15 minutes before the operation until the end of the operation. Control group: No intervention, After 10 minutes of entering the preparation department in the operating room, headphones are played without any music for the patient from 15 minutes before the operation until the end of the operation. Anxiety level before and after the intervention. Timepoint: before intervention and 20 minutes after intervention and after surgery. Method of measurement: Spielberger anxiety questionnaire. Pain level before and after the intervention. Timepoint: before intervention and 20 minutes after intervention and after surgery. Method of measurement: Numerical pain Rating Scale. The patient's vital signs levels. Timepoint: Every 5 minutes in the first half hour and then every 15 minutes until the end of the intervention and at the end of the measurement. Method of measurement: Cardiorespiratory monitoring of the company of Poindangan Rah Saadat, model b9. Sanandaj University of Medical Sciences Approved 2023-04-15 Ethics Committee of Kurdistan University of Medical Sciences Kurdistan University of Medical Sciences, Faculty of Medical, Pasdaran St. Sanandaj Kurdistan Iran (Islamic Republic of)