Atrial Fibrillation Clinical Trial
Official title:
Visualization and Structured Attention Behaviour -- Does it Reduce the Patient's Experience of Pain Intensity and Anxiety During Ablation of Atrial Fibrillation?
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.
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:
The study will test the following hypothesis which also acts as 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.
Design / Methodology:
The Trial is conducted in a cardiac lab. The survey is conducted as a controlled Trial. The
control group receives conventional care and treatment and the intervention group receives
visualization and relaxation exercises together with structured behavioural attention.
The patient scores experienced pain intensity and anxiety in a validated linear numerical
rank scale.
A Statistical calculation of power estimated the required number of patients to 70 in each
group.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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