Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05306015 |
| Other study ID # |
Zhipeng Bao |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2022 |
| Est. completion date |
May 3, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
The First Affiliated Hospital with Nanjing Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
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.
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
