Visualization and Structured Attention Behaviour for Pain and Anxiety Reduction During Ablation of Atrial Fibrillation
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About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Patients referred for ablation of atrial fibrillation
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
140 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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