Atrial FibrillationNCT05306015
Application of Mindfulness Meditation Based on Brain Computer Interface in Radiofrequency Ablation
A study testing Mindfulness meditation based on brain-computer interface and Routine care in people with Atrial Fibrillation and Radiofrequency Ablation, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Radiofrequency Ablation, Meditation
- What is being tested?
- Mindfulness meditation based on brain-computer interface and Routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 3 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Atrial Fibrillation
- Age ≥ 18 years
- First radiofrequency ablation treatment
- Informed consent, voluntary participation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
About this study
Official title: 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.
Read more
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.
Read the detailed description
- 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.
- 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.
- 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.
- 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
- The systolic blood pressure fluctuation is greater than 50mmHG
- Adverse drug reactions during surgery
- Vasovagal seizure
- Persistent chest pain between or after radiofrequency. Breathing disorders, such as difficulty breathing or shortness of breath.
- 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
- Conditions
- Atrial Fibrillation, Radiofrequency Ablation, Meditation, Pain, Fatigue, Anxiety
- Being tested
- Mindfulness meditation based on brain-computer interface, Routine care
- Medical subject headings
- Atrial Fibrillation, Pain, Fatigue, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditation based on brain-computer interfaceCombination 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.
Routine careCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Patients undergoing brain-computer interface-based mindfulness meditation training during the perioperative period of radiofrequency ablation. Receives: Combination Product: Mindfulness meditation based on brain-computer interface |
| control group | Active comparator | Patients receiving routine care for radiofrequency ablation. Receives: Combination Product: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 .
Measured: Within 24 hours after radiofrequency ablation
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: pre ablation, 10 minutes after ablation begin, 20 minutes after ablation begin, 30 minutes after ablation begin, 10minutes after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Apr 2022
- Primary completion30 Sep 2022
- Study completion3 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhipeng Bao, Master, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306015
- Sponsor's protocol ID
- Zhipeng Bao
- Status last verified
- Feb 2024
- First submitted
- 15 Mar 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37133926
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Mindfulness Meditation Based on Brain Computer Interface in Radiofrequency Ablation of Atrial Fibrillation Patients
- ClinicalTrials.gov ID
- NCT05306015
- Acronym / sponsor ID
- Zhipeng Bao
- Conditions
- Atrial Fibrillation, Radiofrequency Ablation, Meditation, Pain, Fatigue, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 3 May 2023 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
- 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
- The systolic blood pressure fluctuation is greater than 50mmHG
- Adverse drug reactions during surgery
- Vasovagal seizure
- Persistent chest pain between or after radiofrequency. Breathing disorders, such as difficulty breathing or shortness of breath.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Combination Product: Mindfulness meditation based on brain-computer interfacePatients undergoing brain-computer interface-based mindfulness meditation training during the perioperative period of radiofrequency ablation. |
| control group | Active comparator | Combination Product: Routine carePatients receiving routine care for radiofrequency ablation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of Atrial Fibrillation
- Age ≥ 18 years
- First radiofrequency ablation treatment
- Informed consent, voluntary participation
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness meditation based on brain-computer interfaceBefore 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 | test group |
| Routine careGive 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. | Combination product | control group |
Primary outcome
Pain intensity
Time frame: 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.
the Brief Fatigue Inventory (BFI)
Time frame: 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)
Time frame: 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 .
4 secondary outcomes
heart rate
Time frame: pre ablation, 10 minutes after ablation begin, 20 minutes after ablation begin, 30 minutes after ablation begin, 10minutes after ablation
blood pressure
Time frame: pre ablation, 10 minutes after ablation begin, 20 minutes after ablation begin, 30 minutes after ablation begin, 10minutes after ablation
respiratory rate
Time frame: pre ablation, 10 minutes after ablation begin, 20 minutes after ablation begin, 30 minutes after ablation begin, 10minutes after ablation
pulse oxygen
Time frame: pre ablation, 10 minutes after ablation begin, 20 minutes after ablation begin, 30 minutes after ablation begin, 10minutes after ablation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 37133926He 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhipeng Bao, Master study chair
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation based on brain-computer interface and Routine care in people with Atrial Fibrillation and Radiofrequency Ablation, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Within 24 hours after radiofrequency ablation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05306015, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.