Visualization and Structured Attention Behaviour -- Does it Reduce the Patient's Experience of Pain Intensity and Anxiety During Ablation of Atrial Fibrillation?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Pain and anxiety is determined from self-reporting by the patient on a validated NRS scale.
研究概览
简要总结
The purpose of this study is to test the efficacy of visualization and relaxation exercises together with a structured behavioural attention from nurses during ablation of atrial fibrillation.
The study will test the following hypothesis which is also aim for intervention:
Relaxation and visualization performed in patients during ablation of atrial fibrillation combined with structured attention behaviour from the nurse reduces the patient's experience of pain and anxiety - and secondary reduces the consumption of painkillers and the number of episodes of adverse outcome that requires extra attention from staff.
The survey is conducted as a controlled trial with a control group and an intervention group.
详细描述
Background:
Atrial fibrillation (AF) is the most common form of cardiac arrhythmia with a prevalence of 5% among people older than 65 years, and 0.4% of the total population. Ablation is a relatively new treatment that has proven to be effective in removing physical symptoms in patients with severe symptoms.
Compared to other ablation treatments, ablation of AF is complex and of longer duration. It can be accompanied by significant discomfort and pain, despite pharmacological analgesia.
Non pharmacological analgesia in the form of relaxation exercises and visualization has successfully been used to reduce the experience of pain intensity and anxiety of other invasive procedures.
Aim:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patients referred for ablation of atrial fibrillation
排除标准
- •Unable to give informed consent
- •Impaired mental function, psychosis, severe chronic obstructive pulmonary disease, intolerance towards midazolam or fentanyl
- •Undergoing the ablation in general anaesthesia
- •Unable to speak or understand danish
研究组 & 干预措施
Control group
The control group receives conventional care and treatment
Intervention group
the intervention group receives visualization and relaxation exercises together with structured behavioural attention
干预措施: visualization together with structured behavioural attention. (Behavioral)
结局指标
主要结局
Pain and anxiety is determined from self-reporting by the patient on a validated NRS scale.
时间窗: Day 1 :Patient self-reporting every 15 minutes from the onset of the ablation procedure to the end of the ablation procedure. In addition self-reporting is recorded if the patient complains in between these fixed measurement points. No follow-up.
次要结局
- Amount of Medication used /kg (Fentanyl and Midazolam) during the ablation procedure)(Day 1: From the onset to the end of the ablation procedure. No follow-up.)
- Number of adverse events during the ablation procedure(Day 1: Are recorded whenever they occur from the onset, to the end of the ablation procedure. No follow-up.)