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

NCT05306015 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-02-28

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Zhipeng Bao, Master · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2022-09-30
Completion
2023-05-03

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05306015 on ClinicalTrials.gov