Effects of Mindfulness on Atrial Fibrillation
Effects of Monitored Mindfulness Training on Quality-of-life, Anxiety, and Depression in Patients Awaiting Ablation of Atrial Fibrillation
1 other identifier
interventional
60
1 country
1
Brief Summary
This study aims to investigate the effect of MUSE (R) Headbands on patients with Atrial Fibrillation who is awaiting pulmonary vein isolation ablation procedure. Patients are randomized in 2 arms. The control arm will not be receiving the MUSE headband, whereas the treatment group obtains a device. Patients from both group will fill out a quality-of-life questionnaire at the time of enrollment and 3 months post PVI. Results from both arms will be evaluated and ultimately the effect of mindfulness using the headband will be evaluated in the aforementioned patient population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable atrial-fibrillation
Started Aug 2015
Typical duration for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 29, 2015
CompletedFirst Posted
Study publicly available on registry
September 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedMarch 29, 2018
March 1, 2018
3.3 years
September 29, 2015
March 27, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Life
patients in both arms will fill out a questionnaire for QoL 12 weeks after their ablation.
12 weeks
Study Arms (2)
Control
NO INTERVENTIONThese patients will not receive a device, but have to fill out a quality of life questionnaire at the time of enrollment and 3 months after their procedure.
Treatment Group
EXPERIMENTALThese patients will receive the device. they are expected to use it for at least 5 minutes per day. Patients in this arm will fill out a quality of life questionnaire at the time of enrollment and 3 months after their procedure.
Interventions
Eligibility Criteria
You may qualify if:
- Age over 18
- symptomatic persistent or paroxysmal AF awaiting ablation of AF
You may not qualify if:
- Known Anxiety and Depression
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southlake Regional Health Centre
Newmarket, Ontario, L3Y 2P9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Atul Verma, MD
Newmarket Electrophysiology Research Group
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Associate
Study Record Dates
First Submitted
September 29, 2015
First Posted
September 30, 2015
Study Start
August 1, 2015
Primary Completion
December 1, 2018
Study Completion
May 1, 2019
Last Updated
March 29, 2018
Record last verified: 2018-03