Meditation and Education That is Nurse Delivered for Symptom Management in Paroxysmal Atrial Fibrillation (PAF)
NCT ID: NCT03834844
Last Updated: 2024-12-02
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2018-05-01
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Usual Care
patient receives same care as patients not enrolled in study intervention
No interventions assigned to this group
AF education
Participant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week.
AF Education
6 weekly education modules on topics related to AF
Mindfulness Meditation Practice
Each participant watches an mindfulness meditation introductory video in the initial session and then is asked to practice for 10 minutes each day using a guided audio, which includes a different topic each week. The time duration of the guided meditations increases to 15 minutes each day during Weeks 3-6.
Meditation
Guided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks
Weekly Phone Calls
Each week for the six-week intervention, the researcher will contact the participant by phone at an agreed upon time and will discuss any questions, issues or concerns that are voiced by the participant within 5-15 minutes.
Phone Calls
Weekly phone call to discuss patient concerns or questions
AF Education and Mindfulness Meditation
Participant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week. Each participant watches an mindfulness meditation introductory video in the initial session and then is asked to practice for 10 minutes each day using a guided audio, which includes a different topic each week. The time duration of the guided meditations increases to 15 minutes each day during Weeks 3-6.
Meditation
Guided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks
AF Education
6 weekly education modules on topics related to AF
AF Education and Weekly Phone Calls
Participant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week. Each week for the six-week intervention, the researcher will contact the participant by phone at an agreed upon time and will discuss any questions, issues or concerns that are voiced by the participant within 5-15 minutes.
AF Education
6 weekly education modules on topics related to AF
Phone Calls
Weekly phone call to discuss patient concerns or questions
Mindfulness Meditation and Phone Calls
Each participant watches an mindfulness meditation introductory video in the initial session and then is asked to practice for 10 minutes each day using a guided audio, which includes a different topic each week. The time duration of the guided meditations increases to 15 minutes each day during Weeks 3-6. Each week for the six-week intervention, the researcher will contact the participant by phone at an agreed upon time and will discuss any questions, issues or concerns that are voiced by the participant within 5-15 minutes.
Meditation
Guided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks
Phone Calls
Weekly phone call to discuss patient concerns or questions
Meditation and Education and Phone Calls
Each participant watches an mindfulness meditation introductory video in the initial session and then is asked to practice for 10 minutes each day using a guided audio, which includes a different topic each week. Participant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week. The time duration of the guided meditations increases to 15 minutes each day during Weeks 3-6. Each week for the six-week intervention, the researcher will contact the participant by phone at an agreed upon time and will discuss any questions, issues or concerns that are voiced by the participant within 5-15 minutes.
Meditation
Guided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks
AF Education
6 weekly education modules on topics related to AF
Phone Calls
Weekly phone call to discuss patient concerns or questions
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Meditation
Guided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks
AF Education
6 weekly education modules on topics related to AF
Phone Calls
Weekly phone call to discuss patient concerns or questions
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. A symptomatic episode of PAF within last 6 months
3. 18 years old or greater
4. Able to read and understand English
5. Able to participate in weekly phone calls
6. Able to attend two video visit/phone sessions that are 6 weeks apart
Exclusion Criteria
2. Life expectancy of less than 6 months
3. Hospitalized in prior 3 months for illness other than PAF
4. Previously practiced mindfulness
5. Cognitive impairment
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stanford University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Paul Wang
Professor of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Linda Ottoboni, PhD
Role: PRINCIPAL_INVESTIGATOR
Clinician and research scientist
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford Health Care
Stanford, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB-44919
Identifier Type: -
Identifier Source: org_study_id