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

NCT05306015 | Completed

• 1 other identifier: Zhipeng Bao
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Radiofrequency Ablation; Meditation; Pain; Fatigue; Anxiety; Depression; Brain-Computer Interfaces

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

• respiratory rate

  pre ablation, 10 minutes after ablation begin, 20 minutes after ablation begin, 30 minutes after ablation begin, 10minutes after ablation

• pulse oxygen

  pre ablation, 10 minutes after ablation begin, 20 minutes after ablation begin, 30 minutes after ablation begin, 10minutes after ablation

Other Outcomes (2)

• intraoperative adverse reaction

  intraoperative (during the operation)

• number of oral reports of pain during surgery

  intraoperative (during the operation)

Study Arms (2)

test group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

Patients receiving routine care for radiofrequency ablation.

Combination Product: Routine care

Interventions

Mindfulness meditation based on brain-computer interface COMBINATION_PRODUCT

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.

test group

Routine care COMBINATION_PRODUCT

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.

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

Related Publications (1)

• He Y, Tang Z, Sun G, Cai C, Wang Y, Yang G, Bao Z. Effectiveness of a Mindfulness Meditation App Based on an Electroencephalography-Based Brain-Computer Interface in Radiofrequency Catheter Ablation for Patients With Atrial Fibrillation: Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 May 3;11:e44855. doi: 10.2196/44855.

  PMID: 37133926 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Pain; Fatigue; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Zhipeng Bao, Master

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 31, 2022
• Study Start: April 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: May 3, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

CN (1)