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IRCT20240123060780N3 IRCT 2024-06-08 Kermanshah University of Medical Sciences Effects of sound frequencies on analgesia and hemodynamic changes The effects of using sound frequencies on analgesia level and hemodynamic disorders during intubation and extubation in patients under general anesthesia 2024-07-22 anticipated 175 Complete https://irct.ir/trial/77175 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of samples in this study is done by computer software.Due to the 7 groups, a random order of letters A, B, C, D, E, F, G is made in blocks with a random number of 7 letters. Each letter is a symbol of one of the study groups. Then these obtained blocks are placed in sealed envelopes. Before starting the study, one of the researchers opens one of the envelopes and finally the patient is placed in one of the intervention or control groups, Blinding description: In Control Group 1, headphones were placed over the patient’s ears; however, the headphones had no audio function and contained openings over the ear area, allowing patients to hear environmental sounds naturally. In Control Group 2, intact but inactive headphones were placed over the patient’s ears, preventing the patients from hearing environmental sounds. In the intervention groups, intact headphones were used to deliver auditory stimulation at the specified frequencies. Because the headphones were visually identical and patients were unaware of their group allocation and the frequency of the auditory stimulation, patients were blinded to both group assignment and intervention frequency. An investigator involved in the project was responsible for administering anesthesia and managing the patients throughout the anesthetic period and was blinded to group allocation and stimulation frequency. Auditory stimulation was delivered through the headphones, with the stimulation frequency configured via the headphones’ Bluetooth connection. Another researcher responsible for recording the study variables was unaware of the patients’ group allocation and the frequency of auditory stimulation received and was blinded to both. Statistical analyses were performed after completion of data collection. 2 Condition 1: Pain. Condition 2: surgical pain. Intervention 1: Control 1 group: perforated wireless headphones are placed over both ears, and patients do not receive any auditory stimulus or stimulation intervention. The perforated headphones allow ambient sounds to remain audible. Intervention 2: Control 2 group: passive wireless headphones are placed over both ears to reduce the intensity of ambient sound to less than 5 dB, and patients in this group do not receive any sound stimuli. Intervention 3: Intervention group: patients receive sound stimulation with a frequency of 5 Hz and sound intensity of 50 dB through wireless headphones. Intervention 4: Intervention group: patients receive sound stimulation with a frequency of 10 Hz and sound intensity of 50 dB through wireless headphones. Intervention 5: Intervention group: patients receive sound stimulation with a frequency of 20 Hz and sound intensity of 50 dB through wireless headphones. Intervention 6: Intervention group: patients receive sound stimulation with a frequency of 50 Hz and sound intensity of 50 dB through wireless headphones. Intervention 7: Intervention group: patients receive sound stimulation with a frequency of 100 Hz and sound intensity of 50 dB through wireless headphones. 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 .
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) Not having a history of underlying diseases such as blood pressure, diabetes, heart and lung diseases Patients with American Society of Anesthesiology (ASA) classification 1 and 2 Airway grade 1 Not receiving premedication the night before and the morning of the operation having full normal hearing (25 dB hearing threshold) Having full consciousness 20 years 50 years Both History of smoking and addiction Having an ear infection and anatomical abnormalities of the auditory system Non-cooperation of the patient G89.1 G89.18 Acute pain, not elsewhere classified Other acute postprocedural pain Placebo Placebo Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices Treatment - Devices Control 1 group: perforated wireless headphones are placed over both ears, and patients do not receive any auditory stimulus or stimulation intervention. The perforated headphones allow ambient sounds to remain audible. Control 2 group: passive wireless headphones are placed over both ears to reduce the intensity of ambient sound to less than 5 dB, and patients in this group do not receive any sound stimuli. Intervention group: patients receive sound stimulation with a frequency of 5 Hz and sound intensity of 50 dB through wireless headphones. Intervention group: patients receive sound stimulation with a frequency of 10 Hz and sound intensity of 50 dB through wireless headphones. Intervention group: patients receive sound stimulation with a frequency of 20 Hz and sound intensity of 50 dB through wireless headphones. Intervention group: patients receive sound stimulation with a frequency of 50 Hz and sound intensity of 50 dB through wireless headphones. Intervention group: patients receive sound stimulation with a frequency of 100 Hz and sound intensity of 50 dB through wireless headphones. Heart rate. Timepoint: It is measured immediately and at 1, 2, 3, 4, and 5 minutes after intubation and extubation. Method of measurement: Using monitoring connected to the patient. Mean arterial pressure. Timepoint: It is measured immediately and at 1, 2, 3, 4, and 5 minutes after intubation and extubation. Method of measurement: using a monitor connected to the patient. Anxiety. Timepoint: It is measured before induction of anesthesia. Method of measurement: The visual analog scale. Comfort. Timepoint: It is measured before induction of anesthesia. Method of measurement: The visual analog scale. Pain. Timepoint: Before discharge from the recovery unit and at 1, 3, and 6 hours after surgery. Method of measurement: The visual analog scale. Systolic and diastolic blood pressure. Timepoint: Every 15 minutes during anesthesia and also before leaving the recovery room. Method of measurement: using a monitor connected to the patient. Heart rate. Timepoint: Every 15 minutes during anesthesia and also before leaving the recovery room. Method of measurement: Using patient-connected monitoring. Bispectral Index value during general anesthesia. Timepoint: Before induction of general anesthesia, after induction of general anesthesia, and at 15, 30, 45, and 60 minutes, as well as after extubation. Method of measurement: Continuous monitoring using a bispectral index monitor with a disposable forehead sensor. The amount of narcotic drugs used for analgesia (morphin) in the recovery department. Timepoint: It is measured in the recovery section. Method of measurement: In terms of milligrams of the drug injected by anesthesia personnel. 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)