An interventional study of Binaural beat music recital in Spinal Anesthesia and Knee Arthroplasty, sponsored by Nuh Naci Yazgan University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by Nuh Naci Yazgan University · Not applicable, Interventional, and Supportive care
The aim of this study is to examine the effects of binaural beat music played during spinal anesthesia knee arthroplasty on anxiety, pain and cortisol levels. The study was planned as a randomized controlled experimental design study. The hypotheses of the study are as follows;
A sample group will be formed with 20 patients in the intervention group and 20 patients in the control group. Binaural beat music will be played in the intervention group during the surgical procedure, and routine interventions will be applied to the control group.
Data collection in the intervention group is as follows;
The control group data collection methods are as follows;
Knee arthroplasty is one of the most commonly used surgeries in orthopedics. Pain and anxiety are two main problems among patients undergoing orthopedic surgeries.
Being conscious during spinal anesthesia, potential risk, and expectation of postoperative pain contribute to anxiety and fear. Since the patient is fully conscious throughout the procedure, patients undergoing spinal anesthesia are more aware of the noise in the environment. Noise can cause stress, changes in the autonomic nervous system, and increase anxiety.
On the other hand, the surgical procedure itself also causes anxiety in the patient. Fear of surgical failure, lack of knowledge of the anesthesia methodology, possible risks of anesthesia, fear of the unknown, and expected pain during postoperative recovery cause increased anxiety.
The pain and anxiety experienced by surgical patients bring about psychological and physiological changes that significantly affect the course of the surgery, the recovery process, and the prognosis. Anxiety increases cortisol secretion through the autonomic nervous system. However, postoperative anxiety affects the pain response and strengthens the pain perception experienced by the patient. Since the intensity of pain can vary depending on the patient's anxiety, relieving anxiety can also facilitate pain management. Anxiety strengthens the perception of pain, and pain also causes anxiety in patients. In addition, anxiety and pain can reduce patient satisfaction. The irregularity in these psychological and physiological parameters caused by pain and anxiety can be reduced using pharmacological and non-pharmacological interventions. Music-based interventions are non-invasive, economical and non-pharmacological nursing interventions that do not require special skills to be applied, are safe, and also reduce pain and anxiety. Since they do not require a physician's order and have minimal fatal and ethical concerns, they can be easily incorporated into nursing care. Music-based interventions reduce pain and anxiety by distracting attention from stressful events such as pain and anxiety, allowing the music to focus on itself and related experiences/memories, i.e. another stimulus. The anxiolytic effect of music is achieved by suppressing the nervous system due to decreased adrenergic activity and neuromuscular stimulation. Music also stimulates the brain's limbic system to secrete endorphins, providing a sense of well-being. As a result, it reduces pain by increasing endorphin secretion and creating pleasant feelings. Music-based interventions can also reduce anxiety specifically by physiologically acting on the hypothalamic-pituitary-adrenal axis and reducing cortisol levels.
There is increasing interest in music interventions using binaural beats because it normalizes arrhythmias and provides relaxation in surgical patients. Binaural beat music is a therapeutic tool used to reduce anxiety and pain in patients undergoing surgical procedures. It has been reported that binaural beat music is successful as a non-pharmacological treatment method and is more effective than general music in reducing anxiety.
Music-based interventions for surgical pain and anxiety have been evaluated in many studies over the past few decades, but there are differences in the type and duration of intervention, the length of the evaluation, and other methodological issues. In this study, the intervention group will be provided with listening to music with headphones during the surgical procedure. Because therapeutic environments such as operating rooms are quiet, relatively secluded, and away from noise, which increases the success rate. However, in addition to the use of tools such as hammers, suction devices, and anesthetic monitors during orthopedic surgical procedures, the noise level associated with metal equipment also contributes to the noise level of operating rooms. While the noise level exceeds 100 dB more than 40% of the time in orthopedic surgical procedures, the highest noise level reached during the surgical procedure is over 120 dB. It has been stated that using headphones together with music to keep patients away from noise can reduce the anxiety caused by noise in the operating room and increase overall patient satisfaction. Using headphones increases a patient's focus on music and prevents other people nearby from being disturbed. Since patients receiving spinal anesthesia are more aware of the noise in the environment, in our study, the intervention group will be isolated from the noise by having them listen to music through headphones during the surgical procedure.
Exclusion Criteria:
Binaural beat music is therapeutic music that provides auditory stimuli at different frequencies to each ear. However, the maximum sound levels of 60 dB help to relax and reduce stress. There are studies that show that a slower rhythm and a slower decibel music makes the heart beats compatible with the rhythm. Support from an audiologist will be sought to adjust the volume of the binaural beat music to 50 dB. Natural sounds such as birdsong, waterfalls, ocean, river and forest sounds will be added to the soothing components of the melodies, tones and rhythms embedded in the binaural beats and 60-minute music arrangements will be created in the computer program. The resulting binaural beat music will be loaded into the Goldplay GP-1001 brand Mp3 player and listened to using headphones.
Other: Binaural beat music recital
Routine interventions will be applied to the control group without listening to music.
Binaural beats music is therapeutic music that provides auditory stimuli at different frequencies to each ear. However, the maximum sound levels are 60 dB, which helps to relax and reduce stress.
State Anxiety Inventory
It is the State Anxiety Inventory Form that will be used for the subjective evaluation of patients' anxietyThe State Anxiety Inventory Form is a highly sensitive tool for assessing sudden changes in emotional reactions.
Time frame: Through study completion, an average of 2 months
Visual Analog Scale
The Visual Comparison Scale, which will be used to evaluate the level of pain and patient satisfaction with knee arthroplasty, consists of a 10 cm long horizontal line.
Time frame: Through study completion, an average of 2 months
Cortisol level
Anxiety increases cortisol secretion via the autonomic nervous system, causing an increase in cortisol levels. In this study, blood cortisol levels will be evaluated as objective data of anxiety.Cortisol levels gradually decrease throughout the day, exhibiting a 24-hour circadian rhythm. Cortisol levels are highest in the morning and lowest at midnight. To avoid being affected by this circadian shift, the first cases of the day will be included in the study.
Time frame: Through study completion, an average of 2 months
Plan to share: No — I won't share it right now because it's a work in progress.
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