Recruiting

Mindfulness

Sponsor:

Newmarket Electrophysiology Research Group Inc

Code:

NCT02564302

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MUSE Headband

Study Details

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.

Conditions

Atrial Fibrillation

Study ID

NCT02564302

Start date

Aug, 2015

Status verified date

Mar, 2018

Completion date

May, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age over 18
  • symptomatic persistent or paroxysmal AF awaiting ablation of AF

Exclusion Criteria:

  • Known Anxiety and Depression

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

These 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.

experimental: Treatment Group

These 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

MUSE Headband

MUSE Headband will help patients with mindfulness.

Primary outcome measure

  • Quality of Life [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Pouria Alipour, BSc

9058954521palipour@southlakeregional.org

Annette Nath, RN

9058954521anath@southlakeregional.org

Locations

Southlake Regional Health Centre

Recruiting

Newmarket, Ontario, Canada, L3Y 2P9

Contacts

Pouria Alipour, BSc

905-895-4521PAlipour@southlakeregional.org

Annette Nath, RN

905-895-4521ANath@southlakeregional.org

Principal Investigator:

Atul Verma, MD

More Information

Sponsor

Newmarket Electrophysiology Research Group Inc

Last update posted

Mar 29, 2018

Last verified

Mar, 2018

Keywords

  • PVI
  • Atrial Fibrillation
  • MUSE Headband
  • Mindfulness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Newmarket Electrophysiology Research Group Inc on 2018-03-29.