Effect of Binaural Beat Music Played During Knee Arthroplasty With Spinal Anesthesia on Anxiety, Pain and Cortisol Levels.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Visual Analog Scale
研究概览
简要总结
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;
- Binaural beat music played during spinal anesthesia knee arthroplasty has no effect on anxiety.
- Binaural beat music played during spinal anesthesia knee arthroplasty has an effect on anxiety.
- Binaural beat music played during spinal anesthesia knee arthroplasty has no effect on pain levels.
- Binaural beat music played during spinal anesthesia knee arthroplasty has an effect on pain levels.
- Binaural beat music played during spinal anesthesia knee arthroplasty has no effect on cortisol levels.
- Binaural beat music played during spinal anesthesia knee arthroplasty has an effect on cortisol levels.
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;
- Patients will be interviewed in the surgery clinic before surgery and the descriptive characteristics form and the State Anxiety Inventory Form will be filled out.
- The 1st measurement of hemodynamic data will be recorded immediately before the surgery
- A musical concert will be started as soon as the surgery begins
- The musical concert will end when the surgery ends
- The 2nd measurement will be recorded immediately after the surgery ends
- In the post-surgery collection unit, the State Anxiety Inventory Form and the Visual Comparison Scale will be used, and a blood sample will be taken to determine cortisol values.
The control group data collection methods are as follows;
- Patients will be interviewed in the surgical clinic before surgery and the descriptive characteristics form and the State Anxiety Inventory Form will be filled in
- The first measurement of hemodynamic data will be recorded immediately before the surgical procedure
- The second measurement will be recorded immediately after the surgical procedure is completed
- Blood samples will be taken in the post-surgical recovery unit to determine the State Anxiety Inventory Form, Visual Comparison Scale and cortisol values.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are older than 18 years,
- •Who have undergone unilateral knee arthroplasty under spinal anesthesia for the first time,
- •Who can communicate verbally,
- •Who are in the ASA 1-2-3 group,
- •Who do not have a neurological or psychiatric diagnosis will be included in the study.
- •Since cortisol levels will be measured in our study, the first cases of the day will be included in the study.
排除标准
- •Patients who refused to participate in the study were those with hearing impairment due to age or disease,
- •Those who had any contraindications for spinal anesthesia,
- •Those who were transferred to intensive care after the procedure,
- •Those who developed complications during and after the procedure,
- •Those who underwent general anesthesia,
- •Those whose type of anesthesia was changed during surgery.
研究组 & 干预措施
Intervention group
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.
干预措施: Binaural beat music recital (Other)
Control group
Routine interventions will be applied to the control group without listening to music.
结局指标
主要结局
Visual Analog Scale
时间窗: Through study completion, an average of 2 months
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.
Cortisol level
时间窗: Through study completion, an average of 2 months
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.
State Anxiety Inventory
时间窗: Through study completion, an average of 2 months
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.
次要结局
未报告次要终点
研究者
Fadime Ertural
Principal Investigator
Nuh Naci Yazgan University
