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临床试验/NCT02564302
NCT02564302Unknown不适用

Effects of Monitored Mindfulness Training on Quality-of-life, Anxiety, and Depression in Patients Awaiting Ablation of Atrial Fibrillation

Newmarket Electrophysiology Research Group Inc1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年8月1日最近更新:
适应症
干预措施

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

No Intervention

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

Experimental

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

发起方
Newmarket Electrophysiology Research Group Inc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pouria Alipour

Research Associate

Newmarket Electrophysiology Research Group Inc

研究点 (1)

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