Effects of Monitored Mindfulness Training on Quality-of-life, Anxiety, and Depression in Patients Awaiting Ablation of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Quality of Life
研究概览
简要总结
This study aims to investigate the effect of MUSE (R) Headbands on patients with Atrial Fibrillation who is awaiting pulmonary vein isolation ablation procedure. Patients are randomized in 2 arms. The control arm will not be receiving the MUSE headband, whereas the treatment group obtains a device.
Patients from both group will fill out a quality-of-life questionnaire at the time of enrollment and 3 months post PVI. Results from both arms will be evaluated and ultimately the effect of mindfulness using the headband will be evaluated in the aforementioned patient population.
详细描述
Background:
Atrial fibrillation is the most common arrhythmic disorder and ablation of AF has become an important part of AF treatment. AF is associated with a large number of somatic symptoms like chest pain, fatigue, lightheadedness, palpitations, physical limitations, shortness of breath, irregular rhythm and heart rate but also with psychological comorbidities such as anxiety and depression [1]. In recent years, the severity of these comorbidities has become more apparent in AF patients. For instance, Sears and colleagues found a positive correlation between the number of AF symptoms reported and the number of negative emotions experienced [2]. Since there is prospective data on the effects of AF ablation on long term mortality and morbidity, reduction of AF related symptoms and improvement of quality of life (QoL) is still a major goal of AF ablation [3,4].
Mindful meditation (MM) is a basic form of meditation that involves focusing on one thing internally or externally. Being fully present in the moment is the goal of MM. Practicing MM teaches relaxation and concentration on experiencing bodily sensations such as breathing patterns. Mindfulness is independent of environmental stimuli; it is a state of mind that can be achieved at any time [5]. Studies show that, with practice, this form of meditation can provide both long- and short-term positive effects with respect to reduction in anxiety and depression[6,7]. Immediate and transferable benefits for AF patients include self-regulated attention, heightened perception of internal states, reduced stress and anxiety symptoms, and increased overall well-being.
Mindfulness training can heighten meta-cognitive processing, which can improve a person's ability to control adverse thoughts and feelings. Consistent mindful meditation training can induce neuroplasticity[7,8].
The amygdala is a crucial brain structure that is hyperactive during perceived stressful conditions [8]. Being able to utilize skills to control emotions in stressful situations will be beneficial in controlling psychological hyperactivity. Studies show after mindful-attention training there is a decrease in amygdala activity even when in a non-meditative state [6]. This is proof that skills obtained during meditation have lasting positive neural effects. In another study, Holzel et al. found that after eight weeks of MM training, there was a significant correlation between a decrease in subjective stress and a decrease in amygdala's gray matter density. Therefore, a reduction in stress output is positively correlated with gray matter density. MM training induces brain changes in the amygdala and resting state connectivity, which have impacts on cognition such as an increase in attentional control and executive function [9].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18
- •symptomatic persistent or paroxysmal AF awaiting ablation of AF
排除标准
- •Known Anxiety and Depression
研究组 & 干预措施
Control
These patients will not receive a device, but have to fill out a quality of life questionnaire at the time of enrollment and 3 months after their procedure.
Treatment Group
These patients will receive the device. they are expected to use it for at least 5 minutes per day. Patients in this arm will fill out a quality of life questionnaire at the time of enrollment and 3 months after their procedure.
干预措施: MUSE Headband (Device)
结局指标
主要结局
Quality of Life
时间窗: 12 weeks
patients in both arms will fill out a questionnaire for QoL 12 weeks after their ablation.
次要结局
未报告次要终点
研究者
Pouria Alipour
Research Associate
Newmarket Electrophysiology Research Group Inc
