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

NCT01162811 | Completed

• 1 other identifier: J. nr. 2007-58-0015.).
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Visualization; relaxation; self hypnotic relaxation; hypnosis; invasive medical procedures; atrial fibrillation; ablation; catheter ablation; pain; anxiety

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

• Amount of Medication used /kg (Fentanyl and Midazolam) during the ablation procedure)

  Day 1: From the onset to the end of the ablation procedure. No follow-up.

• Number of adverse events during the ablation procedure

  Day 1: Are recorded whenever they occur from the onset, to the end of the ablation procedure. No follow-up.

Study Arms (2)

Control group

NO INTERVENTION

The control group receives conventional care and treatment

Intervention group

EXPERIMENTAL

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

Behavioral: visualization together with structured behavioural attention.

Interventions

visualization together with structured behavioural attention. BEHAVIORAL

visualization and relaxation exercises together with structured behavioural attention.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for ablation of atrial fibrillation

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Coepenhagen University Hospital, Rigshospitalet

Copenhagen, Copenhagen Ø, DK 2100, Denmark

Location

MeSH Terms

Conditions

Atrial Fibrillation; Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Study Officials

• Preben U Pedersen, RN, PhD

  The Cardiac Cath.lab. The Heartcenter,Rigshospitalet, Copenhagen Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 15, 2010
• Study Start: November 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 21, 2011

Record last verified: 2009-11

Locations

DK (1)