Visualization and Structured Attention Behaviour for Pain and Anxiety Reduction During Ablation of Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01162811
First received: July 8, 2010
Last updated: July 20, 2011
Last verified: November 2009

July 8, 2010
July 20, 2011
November 2009
July 2011   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01162811 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
    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
Same as current
Not Provided
Not Provided
 
Visualization and Structured Attention Behaviour for Pain and Anxiety Reduction During Ablation of Atrial Fibrillation
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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Atrial Fibrillation
Behavioral: visualization together with structured behavioural attention.
visualization and relaxation exercises together with structured behavioural attention.
  • No Intervention: Control group
    The control group receives conventional care and treatment
  • Experimental: Intervention group
    the intervention group receives visualization and relaxation exercises together with structured behavioural attention
    Intervention: Behavioral: visualization together with structured behavioural attention.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
July 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01162811
J. nr. 2007-58-0015.).
No
Marianne Wetendorff Noergaard, Cardiac Cath.lab 2012, Rigshospitalet. Blegdamsvej 9, DK- 2100, Copenhagen Ø Denmark
Rigshospitalet, Denmark
Not Provided
Study Chair: Preben U Pedersen, RN, PhD The Cardiac Cath.lab. The Heartcenter,Rigshospitalet, Copenhagen Denmark
Rigshospitalet, Denmark
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP