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IRCT20240123060780N2 IRCT 2024-02-19 Kermanshah University of Medical Sciences Effect of sound frequencies on pain level Investigating effects of sound frequencies on pain, comfort and anxiety levels in venous-arterial blood sampling, intramuscular injection, and venous intra-vascular access process 2024-04-13 anticipated 300 Complete https://irct.ir/trial/75565 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization of the samples in this study is done by computer software. By the software, a random sequence of letters A, B, C, D, E, F, G, H, I, G is assigned to the intervention and control groups. . In the output of the software, blocks are created with a sequence of 8 and 10 random letters (each letter is considered for a group). Then these obtained blocks are placed in sealed envelopes. Before starting the study, one of the researchers opens one of the envelopes and finally, according to the sequence of letters, the patient is placed in one of the intervention or control groups, Blinding description: In control group 1; Headphones are placed on the patient's ear. But the headphones have no function, and the patient is able to hear the surrounding sounds naturally through the holes made on the ear part of the headphones. In control group 2; Healthy headphones but without sound function are placed on the patient's ear so that he cannot hear the surrounding sounds. In the intervention groups; Healthy headphones with sound function with a specific frequency are used. Due to the identical appearance of the interventions and the patient's lack of information about the grouping and type of stimulation intervention frequency, the patients were blinded to the intervention. Blood sampling and intramuscular injections are done by the co-colleague. Audio frequency was applied through headphones and audio frequency settings were done through Bluetooth headphones. The other colleague who registers the variables does not know how to group and the type of frequency received by the patients. 3 Pain. Intervention 1: Control group: during each of the procedures, the patients do not receive any stimulation or analgesia, and the procedure is performed according to the routine of the department and the noise level of the environment. Intervention 2: Control group: during each of the procedures, passive wireless headphones are placed on both ears of the patients so that the intensity of the ambient sound is less than 5 dB, and the patients in this group do not receive any sound stimuli. Intervention 3: Intervention group: 5 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 5 Hz is performed from one minute before the procedure until its completion. Intervention 4: Intervention group: 10 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 10 Hz is performed from one minute before the procedure until its completion. Intervention 5: Intervention group: 15 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 15 Hz is performed from one minute before the procedure until its completion. Intervention 6: Intervention group: 20 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 20 Hz is performed from one minute before the procedure until its completion. Intervention 7: Intervention group: 30 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 30 Hz is performed from one minute before the procedure until its completion. Intervention 8: Intervention group: 40 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 40 Hz is performed from one minute before the procedure until its completion. Intervention 9: Intervention group: 50 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 50 Hz is performed from one minute before the procedure until its completion. Intervention 10: Intervention group: 100 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 100 Hz is performed from one minute before the procedure until its completion. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No decision has been made yet.
public Said mohamadi
School of Medicine, St. University, shahid Shiroudi Boulevard, Kermanshah
Kermanshah Iran (Islamic Republic of) 6714869914 +98 83 3427 4618 dr.saidmohamadi@gmail.com Kermanshah University of Medical Sciences scientific Said mohamadi
School of Medicine, St. University, shahid Shiroudi Boulevard, Kermanshah
Kermanshah Iran (Islamic Republic of) 6714869914 +98 83 3427 4618 dr.saidmohamadi@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Full consciousness Literacy, reading, writing Verbal ability and healthy vision The skin of the study area should be healthy No peripheral edema in the intervention area . 25 years 60 years Both Addiction Taking sedatives and anesthetic during the last 24 hours Having a pacemaker and implantable cardiac device and defibrillators History of diabetes Patient restlessness G89.1 Acute pain, not elsewhere classified Placebo Placebo Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices Control group: during each of the procedures, the patients do not receive any stimulation or analgesia, and the procedure is performed according to the routine of the department and the noise level of the environment. Control group: during each of the procedures, passive wireless headphones are placed on both ears of the patients so that the intensity of the ambient sound is less than 5 dB, and the patients in this group do not receive any sound stimuli. Intervention group: 5 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 5 Hz is performed from one minute before the procedure until its completion. Intervention group: 10 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 10 Hz is performed from one minute before the procedure until its completion. Intervention group: 15 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 15 Hz is performed from one minute before the procedure until its completion. Intervention group: 20 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 20 Hz is performed from one minute before the procedure until its completion. Intervention group: 30 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 30 Hz is performed from one minute before the procedure until its completion. Intervention group: 40 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 40 Hz is performed from one minute before the procedure until its completion Intervention group: 50 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 50 Hz is performed from one minute before the procedure until its completion. Intervention group: 100 Hz sound stimulation group: wireless headphones are placed on both ears one minute before each procedure. Sound stimulation with a frequency of 100 Hz is performed from one minute before the procedure until its completion. Pain. Timepoint: The pain level is measured immediately after the procedure and also in 1, 3 and 5 minutes after the procedure is completed. Method of measurement: The visual analog scale. Comfort level. Timepoint: It is measured in 5 minutes after each procedure (injection or blood sampling). Method of measurement: The visual analog scale. Stress level. Timepoint: 5 minutes after each procedure. Method of measurement: The visual analog scale. Heart rate. Timepoint: The hear rate is measured before and after procedure (injection and blood sampling) and also in 1, 3 and 5 minutes after the procedure is completed. Method of measurement: Using portable pulse oximetry. Kermanshah University of Medical Sciences Approved 2024-01-30 Ethics committee of Kermanshah University of Medical Sciences No. 2 Central Building, Kermanshah University of Medical Sciences, Shahid Beheshti Street, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)