Ear Acupressure for Reducing Anxiety and Pain During Heart Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
Acupuncture and acupressure, rooted in Traditional Chinese Medicine, are used to treat a variety of symptoms. One specific and easy-to-apply method is ear acupuncture/acupressure following the NADA protocol (developed by the National Acupuncture Detoxification Association in 1985 in New York). This technique has been used successfully in Germany since 1995. It is known for its balancing and stabilizing effects on both body and mind, helping to reduce symptoms such as anxiety and stress, and promoting relaxation and inner calm.
Open-heart surgery can be emotionally overwhelming for patients, often triggering intense existential fears. Preoperative anxiety may worsen physical and psychological symptoms and negatively affect surgery outcomes. Therefore, non-pharmacological interventions like acupuncture are gaining importance alongside medication.
Several studies have demonstrated the effectiveness of preoperative acupuncture in reducing pain, anxiety, and nausea across various surgeries. Randomized trials show significant anxiety reduction through both body and ear acupuncture. One study found that ear acupuncture can rapidly improve psychological well-being, with effects noticeable within five minutes. This suggests its potential use not only the day before surgery but also immediately beforehand.
In contrast, research on ear acupressure before heart surgery is limited. However, one study reported improvements in sleep quality and reduced anxiety. A recent review highlighted the positive effects of ear stimulation on stress, blood pressure, and heart rate, and even suggested that acupressure may be more effective than acupuncture.
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
- None
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
- •All adult patients who are capable of giving consent or willing to do so and who are undergoing elective heart surgery at the Robert Bosch Krankenhaus study center are included.
排除标准
- •Under 18 years old
- •Emergency or urgent surgery
- •Patients who are incapable of giving consent or unwilling to do so
- •Patients who have received acupuncture treatment (including NADA ear acupuncture or acupressure) in the last three months
结局指标
主要结局
Anxiety
时间窗: Preoperative (Day 1)
State-Trait Anxiety Inventory - state (STAI-s) The range of possible scores varies from a minimum of 20 to a maximum of 80, where higher scores represent higher anxiety.
次要结局
- Anxiety(Baseline (Day 0, preoperative), Immediately after the acupressure session (Day 0, preoperative), Postoperative (Day 2 - Day 10 daily until discharged from hospital, on average 10 days))
- Specific preoperative anxiety(Baseline (Day 0, preoperative), Immediately after the acupressure session (Day 0, preoperative), Preoperative (Day 1))
- Quality of life(Baseline (Day 0, preoperative), Discharge from hospital (Day 10 on average))
- Pain intensity(Baseline (Day 0, preoperative), Postoperative (Day 2 - Day 10 daily until discharged from hospital)
- Major Adverse Cardiac and Cerebrovascular Events(Discharge from hospital (Day 10 on average))
- Depression(baseline (Day 0, preoperative))
- Postoperative Nausea and Vomiting(Postoperative (Day 2))
