Clinical trial NCT01162811: Visualization and Structured Attention Behaviour for Pain and Anxiety Reduction During Ablation of Atrial Fibrillation
Official title: Visualization and Structured Attention Behaviour -- Does it Reduce the Patient's Experience of Pain Intensity and Anxiety During Ablation of Atrial Fibrillation?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Visualization
relaxation
self hypnotic relaxation
hypnosis
invasive medical procedures
atrial fibrillation
ablation
catheter ablation
pain
anxiety
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2010-07-15
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain and anxiety is determined from self-reporting by the patient on a validated NRS scale.
timeFrame: 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:
measure: Amount of Medication used /kg (Fentanyl and Midazolam) during the ablation procedure)
timeFrame: Day 1: From the onset to the end of the ablation procedure. No follow-up.
measure: Number of adverse events during the ablation procedure
timeFrame: Day 1: Are recorded whenever they occur from the onset, to the end of the ablation procedure. No follow-up.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Coepenhagen University Hospital, Rigshospitalet
state: Copenhagen Ø
Study officials:
affiliation: The Cardiac Cath.lab. The Heartcenter,Rigshospitalet, Copenhagen Denmark
name: Preben U Pedersen, RN, PhD
role: STUDY_CHAIR
References: