Clinical trial NCT05306015: Application of Mindfulness Meditation Based on Brain Computer Interface in Radiofrequency Ablation
Official title: Application of Mindfulness Meditation Based on Brain Computer Interface in Radiofrequency Ablation of Atrial Fibrillation Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Radiofrequency Ablation
Meditation
Pain
Fatigue
Anxiety
Depression
Brain-Computer Interfaces
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 1. 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.

   3.2.Sample size calculation

   According to the calculation formula for comparing the two sample averages: n1= n2=2×(μα+μβ)2×σ2/δ2, where μα is the μ value of the first type of error probability (μ0.05=1.6449), and μβ is the second type The μ value of the error probability (μ0.10=1.2816), δ is the allowable error (the absolute value of the difference between the two groups of means), σ2=(Se2+Sc2)/2 (Se and Sc are respectively the study group and the control group Standard deviation). Substituting the above formula, calculating the sample size of each group of 36 cases, considering the 10% loss rate, the total number of cases is 80 cases.

   3.3.Ablation plan

   A unified ablation procedure was used. Analgesia plan: ①Parecoxib sodium 40mg + 10ml normal saline intravenous bolus; ②Fentanyl 0.4mg (4\*2ml/piece) is configured to 40ml, fentanyl is initially 0.001mg/kg intravenously, and then the maintenance dose is 0.001mg /kg/h. If the patient complains of severe pain, speed up the analgesic bolus.

   3.4.Research team

   The research team includes 1 nursing management expert, 1 cardiologist, 2 clinical nurses, 1 clinical nurse who has obtained the national second-level psychological counselor certificate, and 1 nursing graduate student. Two nurses and two nursing graduate students were the main implementers of the intervention program. Psychology lecturers gave them a week of training in behavioral therapy and mindfulness meditation. All nurses in the cath lab have been trained by researchers and have mastered the methods of meditation training.
4. Outcome indicators

   4.1.normal information

   Gender, age, operation method, ablation time, number of discharges, energy, temperature, usage of anesthesia and analgesics, hypertension, diabetes, coronary heart disease, BMI, lvef, ladd, type of atrial fibrillation

   4.2.Specificity index

   Pain intensity, fatigue, anxiety and depression, heart rate, blood pressure, respiratory rate, pulse oxygen

   4.3.Adverse events
   1. The systolic blood pressure fluctuation is greater than 50mmHG
   2. Adverse drug reactions during surgery
   3. Vasovagal seizure
   4. Persistent chest pain between or after radiofrequency. Breathing disorders, such as difficulty breathing or shortness of breath.
5. Data collection method

Before intervention: collect general information and medical records

Intervention: Collect heart rate, blood pressure, pulse oxygen, number of patients reported pain, dosage of anesthesia and analgesics, duration of ablation, adverse events

After intervention: Collect pain score, anxiety and depression score

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Atrial Fibrillation
* Age ≥ 18 years
* First radiofrequency ablation treatment
* Informed consent, voluntary participation

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain intensity
timeFrame: Within 24 hours after radiofrequency ablation
measure: the Brief Fatigue Inventory (BFI)
timeFrame: Within 24 hours after radiofrequency ablation
measure: the State-trait anxiety inventory (STAI)
timeFrame: Within 24 hours after radiofrequency ablation
Secondary outcomes:
measure: heart rate
timeFrame: pre ablation, 10 minutes after ablation begin, 20 minutes after ablation begin, 30 minutes after ablation begin, 10minutes after ablation
measure: blood pressure
timeFrame: pre ablation, 10 minutes after ablation begin, 20 minutes after ablation begin, 30 minutes after ablation begin, 10minutes after ablation
measure: respiratory rate
timeFrame: pre ablation, 10 minutes after ablation begin, 20 minutes after ablation begin, 30 minutes after ablation begin, 10minutes after ablation
measure: pulse oxygen
timeFrame: pre ablation, 10 minutes after ablation begin, 20 minutes after ablation begin, 30 minutes after ablation begin, 10minutes after ablation
Other outcomes:
measure: intraoperative adverse reaction
timeFrame: intraoperative (during the operation)
measure: number of oral reports of pain during surgery
timeFrame: intraoperative (during the operation)
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Zhipeng Bao, Master
role: STUDY_CHAIR
References: