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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
visualization together with structured behavioural attention.
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Atrial Fibrillation focused on measuring Visualization, relaxation, self hypnotic relaxation, hypnosis, invasive medical procedures, atrial fibrillation, ablation, catheter ablation, pain, anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Coepenhagen University Hospital, Rigshospitalet

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm Description

The control group receives conventional care and treatment

the intervention group receives visualization and relaxation exercises together with structured behavioural attention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Amount of Medication used /kg (Fentanyl and Midazolam) during the ablation procedure)
Number of adverse events during the ablation procedure
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

Full Information

First Posted
July 8, 2010
Last Updated
July 20, 2011
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01162811
Brief Title
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

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Visualization, relaxation, self hypnotic relaxation, hypnosis, invasive medical procedures, atrial fibrillation, ablation, catheter ablation, pain, anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group receives conventional care and treatment
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
the intervention group receives visualization and relaxation exercises together with structured behavioural attention
Intervention Type
Behavioral
Intervention Name(s)
visualization together with structured behavioural attention.
Intervention Description
visualization and relaxation exercises together with structured behavioural attention.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.
Title
Number of adverse events during the ablation procedure
Description
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
Time Frame
Day 1: Are recorded whenever they occur from the onset, to the end of the ablation procedure. No follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Preben U Pedersen, RN, PhD
Organizational Affiliation
The Cardiac Cath.lab. The Heartcenter,Rigshospitalet, Copenhagen Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Coepenhagen University Hospital, Rigshospitalet
City
Copenhagen
State/Province
Copenhagen Ø
ZIP/Postal Code
DK 2100
Country
Denmark

12. IPD Sharing Statement

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

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