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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | The control group receives conventional care and treatment | |
| Intervention group | Experimental | the intervention group receives visualization and relaxation exercises together with structured behavioural attention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| visualization together with structured behavioural attention. | Behavioral | visualization and relaxation exercises together with structured behavioural attention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain and anxiety is determined from self-reporting by the patient on a validated NRS scale. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Defined as occurrences requiring extra medical attention to restore hemodynamic and cardiorespiratory stability during the procedure, including systolic blood pressure fluctuation, vasovagal episodes, cardiac events and respiratory impairment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Preben U Pedersen, RN, PhD | The Cardiac Cath.lab. The Heartcenter,Rigshospitalet, Copenhagen Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coepenhagen University Hospital, Rigshospitalet | Copenhagen | Copenhagen Ø | DK 2100 | Denmark |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Day 1: Are recorded whenever they occur from the onset, to the end of the ablation procedure. No follow-up. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001523 | Mental Disorders |