Application of Mindfulness Meditation Based on Brain Computer Interface in Radiofrequency Ablation of Atrial Fibrillation Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- the Brief Fatigue Inventory (BFI)
研究概览
简要总结
In recent years, radiofrequency ablation has gradually become a first-line treatment for patients with atrial fibrillation. Radiofrequency ablation is an invasive procedure that lasts several hours, patients can experience varying degrees of discomfort and pain despite the use of analgesics.
Mindfulness meditation requires the trainer to focus on breathing during the training process, while being non-critical and consciously observing various sensations on the body. It has a good effect in reducing pain, fatigue, negative emotions and strengthening coping with stressful events. With the rapid development of science and technology, meditation is no longer confined to traditional forms. The meditation method with the help of mobile communication technology and brain-computer interface technology can improve efficiency and convenience, and is more personalized. It has been recognized in many studies. The brain-computer interface is to establish a channel between the human brain and the computer that does not rely on conventional brain information output. Using techniques such as electroencephalogram, the spontaneous biopotential of the brain is amplified and recorded from the scalp.
This study aims to explore the impact of mindfulness meditation with devices based on brain-computer interface technology on patients undergoing radiofrequency ablation of atrial fibrillation. In order to improve the negative experience of patients during ablation, ensure the safety of patients during ablation, promote postoperative recovery, and increase satisfaction. The pain intensity, fatigue level, anxiety and depression of the meditation group and the control group were compared by the scale. Record relevant vital signs and adverse events.
The investigators hypothesized that the pain, fatigue, anxiety and depression of the meditation group would be lower than those of the control group.
详细描述
- Research Background
Atrial fibrillation is one of the most common arrhythmias in the world. According to 2020 ESC atrial fibrillation management guidelines, the global prevalence of atrial fibrillation is 2% to 4%. According to a 2021 epidemiological survey in china, there are about 7.9 million patients with atrial fibrillation in China over the age of 45. In the past 11 years, the prevalence of atrial fibrillation in China has increased 20-fold and has caused a huge financial and medical burden. In recent years, radiofrequency ablation has gradually become a first-line treatment for patients with atrial fibrillation. Radiofrequency ablation is an invasive procedure that lasts several hours, patients can experience varying degrees of discomfort and pain despite the use of analgesics. Studies have shown that more than 90% of patients have a strong sense of pain and discomfort during ablation even under deep sedation. In recent years, studies on mindfulness and meditation have been carried out among cardiac patients. Currently there is no application in radiofrequency ablation of atrial fibrillation. However, some studies have reported the application of visual hypnosis during atrial fibrillation ablation and turned out that it could help patients manage pain and anxiety. At the same time, patients have high treatment satisfaction. Studies have shown that meditation equipment based on brain-computer interface and artificial intelligence can show the state of the brain, help users conduct meditation training, and improve sleep. The application of such technologies in clinical nursing work provides new ideas. 2. Research purposes
This study aims to explore the impact of mindfulness meditation with devices based on brain-computer interface technology on patients undergoing radiofrequency ablation of atrial fibrillation. In order to improve the negative experience of patients during surgery, ensure the safety of patients during surgery, promote postoperative recovery, and increase satisfaction. The pain intensity, fatigue level, anxiety and depression of the meditation group and the control group were compared by the scale. Record relevant vital signs and adverse events. 3. Research methods
3.1.Sampling and grouping
Use convenient sampling method to select patients and random number table grouping.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Atrial Fibrillation
- •Age ≥ 18 years
- •First radiofrequency ablation treatment
- •Informed consent, voluntary participation
排除标准
- •With serious organic diseases such as malignant tumors
- •With a history of mental illness or cognitive dysfunction, unable to correctly understand the questionnaire and intervention content
- •Patients who are forced to or voluntarily withdraw due to changes in their condition
研究组 & 干预措施
test group
Patients undergoing brain-computer interface-based mindfulness meditation training during the perioperative period of radiofrequency ablation.
干预措施: Mindfulness meditation based on brain-computer interface (Combination Product)
control group
Patients receiving routine care for radiofrequency ablation.
干预措施: Routine care (Combination Product)
结局指标
主要结局
the Brief Fatigue Inventory (BFI)
时间窗: Within 24 hours after radiofrequency ablation
Fatigue refers to continuous extreme exhaustion. The working ability, mental strength and physical strength are not as good as before. It is a subjective feeling, and this feeling cannot be relieved by rest. It is already a disease state or has become a factor in inducing other diseases. Using the Brief Fatigue Inventory(BFI) to assess the patient's fatigue. According to the presence or absence of fatigue symptoms, it is represented by 0-10, 0 means no fatigue, and 10 means severe fatigue that cannot be relieved.
the State-trait anxiety inventory (STAI)
时间窗: Within 24 hours after radiofrequency ablation
Use the (STAI, Form YI) part of the State-trait anxiety inventory (STAI) to assess anxiety. This scale is mainly used to assess the immediate or recent experiences or feelings of fear, tension, anxiety and neuroticism at a specific time or situation .
Pain intensity
时间窗: Within 24 hours after radiofrequency ablation
According to the International Pain Society, pain is an unpleasant subjective and emotional experience associated with existing or potential tissue damage and has been recognized as the fifth vital indicator. Using the Numeric Pain RatingScale(NPRS) to assess the patient's intraoperative pain level.0-10 means different degrees of pain, 0 means no pain, and 10 means the most severe pain. Patients choose the number that best represents their pain according to their own situation. 1-3 are mild pain, 4-6 are moderate pain, and 7-10 are severe pain.
次要结局
- pulse oxygen(pre ablation, 10 minutes after ablation begin, 20 minutes after ablation begin, 30 minutes after ablation begin, 10minutes after ablation)
- respiratory rate(pre ablation, 10 minutes after ablation begin, 20 minutes after ablation begin, 30 minutes after ablation begin, 10minutes after ablation)
- heart rate(pre ablation, 10 minutes after ablation begin, 20 minutes after ablation begin, 30 minutes after ablation begin, 10minutes after ablation)
- blood pressure(pre ablation, 10 minutes after ablation begin, 20 minutes after ablation begin, 30 minutes after ablation begin, 10minutes after ablation)