Atrial FibrillationNCT01162811
Visualization and Structured Attention Behaviour for Pain and Anxiety Reduction During Ablation of Atrial Fibrillation
A study testing visualization together with structured behavioural attention. in people with Atrial Fibrillation, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- visualization together with structured behavioural attention.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2009to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for ablation of atrial fibrillation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Coepenhagen University Hospital, Rigshospitalet
Copenhagen, Copenhagen Ø, DK 2100
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- visualization together with structured behavioural attention.
- Keywords
- Visualization, relaxation, self hypnotic relaxation, hypnosis, invasive medical procedures, atrial fibrillation, ablation, catheter ablation, pain, anxiety
- Medical subject headings
- Atrial Fibrillation, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visualization together with structured behavioural attention.Behavioural
visualization and relaxation exercises together with structured behavioural attention.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: visualization together with structured behavioural attention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and anxiety is determined from self-reporting by the patient on a validated NRS scale.
Measured: 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)
Measured: Day 1: From the onset to the end of the ablation procedure. No follow-up.
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
Measured: Day 1: Are recorded whenever they occur from the onset, to the end of the ablation procedure. No follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startNov 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Preben U Pedersen, RN, PhD, Study chair, The Cardiac Cath.lab. The Heartcenter,Rigshospitalet, Copenhagen Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162811
- Sponsor's protocol ID
- J. nr. 2007-58-0015.).
- Status last verified
- Nov 2009
- First submitted
- 8 Jul 2010
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualization and Structured Attention Behaviour -- Does it Reduce the Patient's Experience of Pain Intensity and Anxiety During Ablation of Atrial Fibrillation?
- ClinicalTrials.gov ID
- NCT01162811
- Acronym / sponsor ID
- J. nr. 2007-58-0015.).
- Conditions
- Atrial Fibrillation
- Keywords
- Visualization, relaxation, self hypnotic relaxation, hypnosis, invasive medical procedures, atrial fibrillation, ablation, catheter ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 15 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group receives conventional care and treatment |
| Intervention group | Experimental | Behavioral: visualization together with structured behavioural attention.the intervention group receives visualization and relaxation exercises together with structured behavioural attention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients referred for ablation of atrial fibrillation
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| visualization together with structured behavioural attention.visualization and relaxation exercises together with structured behavioural attention. | Behavioural | Intervention group |
Primary outcome
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.
2 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Preben U Pedersen, RN, PhD study chair
The Cardiac Cath.lab. The Heartcenter,Rigshospitalet, Copenhagen Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visualization together with structured behavioural attention. in people with Atrial Fibrillation, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2011.