Effects of Music and Stress Ball Application on Patients During Cataract Surgery Examining the Effect on Anxiety and Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Anxiety (Visual Analog Scale-Anxiety)
研究概览
简要总结
Cataract is one of the leading causes of preventable blindness in the world and in Türkiye. Cataract surgery is one of the most frequently performed and most reliable surgeries for eye diseases. Advances in anesthesia and surgical techniques make it possible for most cataract surgery procedures to be performed under topical anesthetic.
详细描述
This success greatly reduces the duration of surgery, and the side effects associated with local or general anesthesia. However, despite the sedation that can be administered before and during surgery (e.g. benzodiazepines and opioids), patients can experience significant anxiety along with a certain degree of pain and discomfort during surgery. Anxiety causes stress that causes the cardiovascular system to respond by activating the sympathetic nervous system, which causes an increase in heart rate and blood pressure (BP) levels. These mechanisms can complicate the surgical procedure due to increased intraocular pressure. Hypertension and tachycardia above 85 discharges per minute represent an increased risk of orbital bleeding during local anesthetic injection and potential perioperative supracoroidal expulsive bleeding. The sequence and pre-operative music intervention is to be an inexpensive, easy-to-implement technique that has no side effects, has no significant beneficial effects on the anxiety of patients in different surgical populations. Also, music intervention allows for better patient co-operation during surgery under topical anesthesia and a drop in intraoperative blood pressure. Another method that is effective in reducing anxiety and pain is the stress ball. The stress ball is usually a soft toy that is not greater than 7 cm, gets stuck, relieving stress and muscle tension, or manipulated with fingers for exercising the muscles. One of the methods of distracting attention, the stress ball is an effective way of ensuring cognitive focus. The stress ball method has been used to reduce patients' anxiety and pain. Stretching the stress ball during surgery increases the feeling of strength, allowing patients to have direct control over the object. In this way, surgical intervention has a positive effect on anxiety and patient satisfaction without intervention. While the literature includes studies involving the combination of stress ball use and music intervention on surgical patients, there is no research involving combined use of music and stress ball application in cataract surgery in a single study. The investigators work therefore contributes to literature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (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
- 是
入选标准
- •Being 18 years of age or older
- •Not having any hearing or perception problems,
- •Absence of any condition preventing the use of a stress ball (e.g. Parkinson's disease, arthritis, fractures),
- •Having undergone cataract surgery for the first time,
- •Being willing to participate in the research.
排除标准
- •Any use of any analgesic or anxiolytic within 24 hours prior to surgery,
- •Transition from topical to general anesthesia during surgery,
- •Uncontrolled hypertension
研究组 & 干预措施
Control
Pain levels will be tested with VAS 10 minutes before the surgery, and anxiety levels with the VAS-A and Spielberg Continuous Anxiety Scale. The patient in the control group will not be given any intervention.
Stress ball
Pain will be assessed using the Visual Analog Scale (VAS) immediately after surgery and approximately 10 minutes after transfer to the ward. State anxiety will be assessed using the Visual Analog Scale for Anxiety (VAS-A) preoperatively, immediately after surgery while the patient remains on the operating table, and approximately 10 minutes after transfer to the ward. Trait anxiety will be assessed once preoperatively using the State-Trait Anxiety Inventory (STAI-II). Patients assigned to the stress ball group will be instructed to squeeze the stress ball with both hands, count to five while squeezing, and repeat the exercise. The stress ball will be used for 15 minutes during cataract surgery. Patients will be reminded during the procedure to continue the intervention as instructed.
干预措施: Stress ball (Behavioral)
Music intervention
Pain will be assessed using the Visual Analog Scale (VAS) immediately after surgery and approximately 10 minutes after transfer to the ward. State anxiety will be assessed using the Visual Analog Scale for Anxiety (VAS-A) preoperatively, immediately after surgery while the patient remains on the operating table, and approximately 10 minutes after transfer to the ward. Trait anxiety will be assessed once preoperatively using the State-Trait Anxiety Inventory (STAI-II). According to the randomization, patients assigned to the music intervention group will be asked to select their preferred music from a prepared playlist. The playlist will include 50 tracks representing pop music, Turkish classical music, regional folk music, instrumental music, and religious music. The selected music will be played for 15 minutes during cataract surgery.
干预措施: Music intervention (Behavioral)
结局指标
主要结局
Anxiety (Visual Analog Scale-Anxiety)
时间窗: 10 minutes after surgery
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of anxiety he felt on the ruler and the value was measured and recorded.
Pain (Visual Analog Scale)
时间窗: Immediately after surgery
Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain. The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
Anxiety (Visual Analog Scale-Anxiety)
时间窗: approximately 5-10 minutes before surgery
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of anxiety he felt on the ruler and the value was measured and recorded.
Anxiety (Visual Analog Scale-Anxiety)
时间窗: Immediately after surgery
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of anxiety he felt on the ruler and the value was measured and recorded.
State-Trait Anxiety Inventory (STAI-II)
时间窗: Approximately 5-10 minutes before surgery
Trait anxiety will be assessed using the State-Trait Anxiety Inventory-II (STAI-II), which consists of 20 items and measures an individual's general tendency to experience anxiety. Higher scores indicate higher levels of trait anxiety.
Pain (Visual Analog Scale)
时间窗: 10 minutes after surgery
Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain. The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
次要结局
未报告次要终点
研究者
Seda Cansu Yeniğün
Lecturer Dr
Akdeniz University