Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01162811
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : July 21, 2011
Sponsor:
Information provided by:
Rigshospitalet, Denmark

Tracking Information
First Submitted Date  ICMJE July 8, 2010
First Posted Date  ICMJE July 15, 2010
Last Update Posted Date July 21, 2011
Study Start Date  ICMJE November 2009
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2010)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01162811 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2010)
  • 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. ]
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Visualization and Structured Attention Behaviour for Pain and Anxiety Reduction During Ablation of Atrial Fibrillation
Official Title  ICMJE Visualization and Structured Attention Behaviour -- Does it Reduce the Patient's Experience of Pain Intensity and Anxiety During Ablation of Atrial Fibrillation?
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE Behavioral: visualization together with structured behavioural attention.
visualization and relaxation exercises together with structured behavioural attention.
Study Arms  ICMJE
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: July 14, 2010)
140
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01162811
Other Study ID Numbers  ICMJE J. nr. 2007-58-0015.).
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marianne Wetendorff Noergaard, Cardiac Cath.lab 2012, Rigshospitalet. Blegdamsvej 9, DK- 2100, Copenhagen Ø Denmark
Study Sponsor  ICMJE Rigshospitalet, Denmark
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Preben U Pedersen, RN, PhD The Cardiac Cath.lab. The Heartcenter,Rigshospitalet, Copenhagen Denmark
PRS Account Rigshospitalet, Denmark
Verification Date November 2009

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