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Completed

NCT Number: NCT01162811

Visualization and Structured Attention Behaviour for Pain and Anxiety Reduction 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.

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Key information

Conditions

Atrial Fibrillation Anxiety Disorders Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Mental Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coepenhagen University Hospital, Rigshospitalet

Copenhagen, Copenhagen Ø, DK 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

visualization together with structured behavioural attention.

Behavioral

visualization and relaxation exercises together with structured behavioural attention.

Primary outcomes

  1. Pain and anxiety is determined from self-reporting by the patient on a validated NRS scale.

    Time frame: 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.

Secondary outcomes

  1. Amount of Medication used /kg (Fentanyl and Midazolam) during the ablation procedure)

    Time frame: Day 1: From the onset to the end of the ablation procedure. No follow-up.

  2. Number of adverse events during the ablation procedure

    Time frame: Day 1: Are recorded whenever they occur from the onset, to the end of the ablation procedure. No follow-up.

    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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

Visualization and Structured Attention Behaviour -- Does it Reduce the Patient's Experience of Pain Intensity and Anxiety During Ablation of Atrial Fibrillation?

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 15, 2010
Registry last updated
Jul 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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