Application of Mindfulness Meditation Based on Brain Computer Interface in Radiofrequency Ablation

Application of Mindfulness Meditation Based on Brain Computer Interface in Radiofrequency Ablation of Atrial Fibrillation Patients

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.

Study Overview

• Status: Completed
• Conditions: Depression; Pain; Fatigue; Atrial Fibrillation; Anxiety; Meditation; Radiofrequency Ablation; Brain-Computer Interfaces
• Intervention / Treatment: Combination product: Mindfulness meditation based on brain-computer interface; Combination product: Routine care

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

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test group; Patients undergoing brain-computer interface-based mindfulness meditation training during the perioperative period of radiofrequency ablation.	Combination product: Mindfulness meditation based on brain-computer interface; Before surgery, The nurses will teach and explain the methods and significance of meditation training. Let the patient be familiar with the function and background of this method, and explain the use of the headband during the operation, so that the patient believes that meditation training can relieve pain. In surgery, Wear a brain-computer interface headband for the patient to collect EEG, monitor the patient's psychological changes, and provide real-time feedback. The patient wears a Bluetooth headset, according to the patient's preferences, different types of music are selected, and voice playback guides the patient to prepare, relax muscles and regulate breathing. APP judges the patient's meditation state based on EEG signals, and adjusts music, voice guidance. The nurse will give personalized guidance based on the patient's specific situation and the EEG displayed on the APP to help the patient achieve a state of meditation and relaxation.
Active Comparator: control group; Patients receiving routine care for radiofrequency ablation.	Combination product: Routine care; Give routine treatment and care, and increase or decrease the dose or adjust according to the patient's condition in accordance with the doctor's advice. Before surgery, we will introduce the level of medical care involved in the surgery and the equipment of our hospital. Inform the patient of the surgical process and possible pain, and explain in detail the cause, location and characteristics of the pain, including the time when the pain will appear and last. Instruct patients to stabilize their emotions and maintain a calm state of mind. As far as possible to meet the patient's intraoperative care needs, give psychological care, wear a headband to collect EEG signals, but do not intervene in mindfulness meditation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	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.	Within 24 hours after radiofrequency ablation
the Brief Fatigue Inventory (BFI)	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.	Within 24 hours after radiofrequency ablation
the State-trait anxiety inventory (STAI)	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 .	Within 24 hours after radiofrequency ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate	Heart rate refers to the number of heartbeats per minute of normal people in a quiet state, also called resting heart rate, generally 60-100 beats/min. An ECG monitor is used for continuous monitoring. The heart rate will increase under stressful conditions such as tension and pain.	pre ablation, 10 minutes after ablation begin, 20 minutes after ablation begin, 30 minutes after ablation begin, 10minutes after ablation
blood pressure	Blood pressure refers to the lateral pressure acting on the blood vessel wall per unit area when the blood flows in the blood vessel, and it is the driving force to promote the blood flow in the blood vessel. An electronic sphygmomanometer is used for monitoring. The blood pressure range of normal adults in a quiet state is relatively stable, with a normal range of systolic blood pressure of 90～139mmHg, diastolic blood pressure of 60～89mmHg, and pulse pressure of 30～40mmHg.	pre ablation, 10 minutes after ablation begin, 20 minutes after ablation begin, 30 minutes after ablation begin, 10minutes after ablation
respiratory rate	Adopting the breathing monitoring function of the ECG monitor, the normal adult breathing rate is 12-20 times per minute.	pre ablation, 10 minutes after ablation begin, 20 minutes after ablation begin, 30 minutes after ablation begin, 10minutes after ablation
pulse oxygen	Pulse oxygen refers to the blood oxygen saturation detected by the device at the end of the hand, which can indirectly reflect whether the body is hypoxic. The normal level is greater than 94%.	pre ablation, 10 minutes after ablation begin, 20 minutes after ablation begin, 30 minutes after ablation begin, 10minutes after ablation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative adverse reaction	excessive blood pressure fluctuations (systolic blood pressure fluctuations greater than 50mmHG), intraoperative drug adverse reactions (such as nausea and vomiting), vasovagal reaction, persistent chest pain during or after ablation	intraoperative (during the operation)
number of oral reports of pain during surgery	Record the number of spontaneous oral complaints of pain during the operation.	intraoperative (during the operation)

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Study Chair: Zhipeng Bao, Master, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): May 3, 2023

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Zhipeng Bao

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No