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
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Behavioral: visualization together with structured behavioural attention.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Visualization and Structured Attention Behaviour -- Does it Reduce the Patient's Experience of Pain Intensity and Anxiety During Ablation of Atrial Fibrillation?

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 140
Study Start Date: November 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Behavioral: visualization together with structured behavioural attention.
visualization and relaxation exercises together with structured behavioural attention.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162811

Locations
Denmark
Coepenhagen University Hospital, Rigshospitalet
Copenhagen, Copenhagen Ø, Denmark, DK 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Chair: Preben U Pedersen, RN, PhD The Cardiac Cath.lab. The Heartcenter,Rigshospitalet, Copenhagen Denmark
  More Information

No publications provided

Responsible Party: Marianne Wetendorff Noergaard, Cardiac Cath.lab 2012, Rigshospitalet. Blegdamsvej 9, DK- 2100, Copenhagen Ø Denmark
ClinicalTrials.gov Identifier: NCT01162811     History of Changes
Other Study ID Numbers: J. nr. 2007-58-0015.).
Study First Received: July 8, 2010
Last Updated: July 20, 2011
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Rigshospitalet, Denmark:
Visualization
relaxation
self hypnotic relaxation
hypnosis
invasive medical procedures
atrial fibrillation
ablation
catheter ablation
pain
anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Atrial Fibrillation
Mental Disorders
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014