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

July 20, 2011 updated by: Rigshospitalet, Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen Ø
      • Copenhagen, Copenhagen Ø, Denmark, DK 2100
        • Coepenhagen University Hospital, Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1: From the onset to the end of the ablation procedure. No follow-up.
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
Day 1: Are recorded whenever they occur from the onset, to the end of the ablation procedure. No follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Study Chair: Preben U Pedersen, RN, PhD, The Cardiac Cath.lab. The Heartcenter,Rigshospitalet, Copenhagen Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

July 8, 2010

First Submitted That Met QC Criteria

July 14, 2010

First Posted (ESTIMATE)

July 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 21, 2011

Last Update Submitted That Met QC Criteria

July 20, 2011

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J. nr. 2007-58-0015.).

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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