The effects of using sound frequencies on analgesia level and hemodynamic disorders during intubation and extubation in patients under general anesthesia

Determining the effects of using sound frequencies on the level of analgesia and hemodynamic disorders during intubation and extubation in patients under general anesthesia.

The current study is a randomized double-blind clinical trial in phase 2 with a control group, which is conducted on 175 patients. The randomization of the samples is done using the order of random letters by computer software.

The study is conducted on elective candidates for general anesthesia in Imam Reza Hospital, Kermanshah. In the intervention groups, the application of different sound frequencies during the process of general anesthesia is done by headphones. The patients and the researcher who recorded the data do not know about the grouping and the type of intervention.

Patients who are under general anesthesia.

In control group 1; patients do not receive any sound stimulation. In control group 2; passive wireless headphones are placed on both ears of the patient so that the ambient sound intensity is less than 5 dB and the patient does not receive any sound stimuli. In the intervention groups: sound stimulation with frequencies of 5, 10, 20, 50 and 100 Hz from the time of entering the operating room until the patient leaves the recovery room through wireless headphones, receives sound stimulation with a sound intensity of 50 dB.

Changes in blood pressure; change in heart rate ; pain level; comfort; anxiety

This update is being made to clarify and complete the registered information regarding the conduct of the study and to improve the consistency of the trial record with the study protocol and the actual procedures used during the study. These updates do not change the overall nature of the intervention or the main objectives of the study.

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.

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.