Optimizing Quality of Life by Improved Patient Expectation Following Atrial Fibrillation Catheter Ablation
NCT ID: NCT05557526
Last Updated: 2022-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2022-06-09
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Standard Medical Care Control Group
Patients with atrial fibrillation receiving catheter ablation of atrial fibrillation without additional intervention.
No interventions assigned to this group
Optimize Expectation Group
Patients with atrial fibrillation receiving catheter ablation of atrial fibrillation and an additional verbal intervention to optimize the expectation of the patient towards the procedure.
Expectation optimization
A short (2-5 min) verbal intervention will be createad individually based on the expectation of the patient towards the procedure.
Interventions
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Expectation optimization
A short (2-5 min) verbal intervention will be createad individually based on the expectation of the patient towards the procedure.
Eligibility Criteria
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Inclusion Criteria
* indication for pulmonary vein isolation
* sufficient command of the German language
Exclusion Criteria
* permanent atrial fibrillation
* presence of psychiatric disorders which impair the study participitatin
* presence of another medical condiction which influences quality of life stronger than the cardiac condition
* atrial fibrillation induced by intoxication, medicamentation or infection
* inability to grap the course of the study
18 Years
ALL
No
Sponsors
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University Hospital, Essen
OTHER
Evangelical Hospital Düsseldorf
OTHER
Responsible Party
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Christian Meyer
Head of the Division of Cardiology, Angiology and Intensive Care
Locations
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Evangelic Hospital Düsseldorf
Düsseldorf, North Rhine-Westfalia, Germany
Countries
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Facility Contacts
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References
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Salzmann S, Euteneuer F, Laferton JAC, Auer CJ, Shedden-Mora MC, Schedlowski M, Moosdorf R, Rief W. Effects of Preoperative Psychological Interventions on Catecholamine and Cortisol Levels After Surgery in Coronary Artery Bypass Graft Patients: The Randomized Controlled PSY-HEART Trial. Psychosom Med. 2017 Sep;79(7):806-814. doi: 10.1097/PSY.0000000000000483.
Rief W, Shedden-Mora MC, Laferton JA, Auer C, Petrie KJ, Salzmann S, Schedlowski M, Moosdorf R. Preoperative optimization of patient expectations improves long-term outcome in heart surgery patients: results of the randomized controlled PSY-HEART trial. BMC Med. 2017 Jan 10;15(1):4. doi: 10.1186/s12916-016-0767-3.
Schedlowski M, Enck P, Rief W, Bingel U. Neuro-Bio-Behavioral Mechanisms of Placebo and Nocebo Responses: Implications for Clinical Trials and Clinical Practice. Pharmacol Rev. 2015 Jul;67(3):697-730. doi: 10.1124/pr.114.009423.
Laferton JA, Auer CJ, Shedden-Mora MC, Moosdorf R, Rief W. Optimizing preoperative expectations in cardiac surgery patients is moderated by level of disability: the successful development of a brief psychological intervention. Psychol Health Med. 2016;21(3):272-85. doi: 10.1080/13548506.2015.1051063. Epub 2015 Jun 4.
Kuniss M, Pavlovic N, Velagic V, Hermida JS, Healey S, Arena G, Badenco N, Meyer C, Chen J, Iacopino S, Anselme F, Packer DL, Pitschner HF, Asmundis C, Willems S, Di Piazza F, Becker D, Chierchia GB; Cryo-FIRST Investigators. Cryoballoon ablation vs. antiarrhythmic drugs: first-line therapy for patients with paroxysmal atrial fibrillation. Europace. 2021 Jul 18;23(7):1033-1041. doi: 10.1093/europace/euab029.
Other Identifiers
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IMPROVE AF
Identifier Type: -
Identifier Source: org_study_id
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