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Meditation + AF Education for Atrial Fibrillation (MEND-AF2 Trial)

N/A

Recruiting

Led By Linda Ottoboni, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (initial), 12 month

Awards & highlights

MEND-AF2 Trial Summary

This trial will study whether a combination of mindfulness meditation, AF education, and weekly phone visits can help reduce symptoms, anxiety, and negative illness perception in people with paroxysmal atrial fibrillation.

Who is the study for?

This trial is for adults with Paroxysmal Atrial Fibrillation (PAF) who've had symptoms in the last 6 months. Participants must be able to engage in weekly phone calls, attend two video/phone sessions six weeks apart, and understand English. Those with severe heart failure, short life expectancy, recent hospitalization for other illnesses, prior mindfulness practice or cognitive issues cannot join.Check my eligibility

What is being tested?

The study tests if a nurse-led program combining Mindfulness meditation, AF education, and weekly phone check-ins can reduce AF symptoms and anxiety while improving quality of life compared to partial or no intervention. The effectiveness of each component alone will also be evaluated.See study design

What are the potential side effects?

Since the interventions are non-medical (meditation and education), significant side effects are not expected. However, participants may experience discomfort or emotional distress during meditation or when discussing their health condition.

MEND-AF2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (initial), 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (initial), 12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (initial), 12 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Atrial Fibrillation

Change from Baseline in AF Quality of Life Score

Secondary outcome measures

Change from Baseline in Anxiety

MEND-AF2 Trial Design

8Treatment groups

Experimental Treatment

Active Control

Group I: Weekly Phone CallsExperimental Treatment1 Intervention

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.

Group II: Mindfulness Meditation and Phone CallsExperimental Treatment2 Interventions

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.

Group III: Mindfulness Meditation PracticeExperimental Treatment1 Intervention

Group IV: Meditation and Education and Phone CallsExperimental Treatment3 Interventions

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.

Group V: AF educationExperimental Treatment1 Intervention

Participant receives 6 modules of AF education topics that are intended to be completed consecutively, one each week.

Group VI: AF Education and Weekly Phone CallsExperimental Treatment2 Interventions

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.

Group VII: AF Education and Mindfulness MeditationExperimental Treatment2 Interventions

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.

Group VIII: Usual CareActive Control1 Intervention

patient receives same care as patients not enrolled in study intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Meditation

2021

Completed Phase 3

~2740

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,380 Total Patients Enrolled

18 Trials studying Atrial Fibrillation

425,570 Patients Enrolled for Atrial Fibrillation

Linda Ottoboni, PhDPrincipal InvestigatorClinician and research scientist

1 Previous Clinical Trials

11 Total Patients Enrolled

1 Trials studying Atrial Fibrillation

11 Patients Enrolled for Atrial Fibrillation

Media Library

Meditation Clinical Trial Eligibility Overview. Trial Name: NCT03834844 — N/A

Atrial Fibrillation Research Study Groups: Meditation and Education and Phone Calls, AF Education and Weekly Phone Calls, Mindfulness Meditation and Phone Calls, Usual Care, AF education, Mindfulness Meditation Practice, Weekly Phone Calls, AF Education and Mindfulness Meditation

Atrial Fibrillation Clinical Trial 2023: Meditation Highlights & Side Effects. Trial Name: NCT03834844 — N/A

Meditation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03834844 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are taking part in this research?

"Affirmative. Per the information on clinicaltrials.gov, this investigation is actively searching for subjects. This trial was listed on May 1st 2018 and updated most recently April 7th 2021; 75 volunteers are needed from a single site."

Answered by AI

Are there any eligibility requirements to participate in the current clinical trial?

"Correct. Clinicaltrials.gov clearly shows that this medical research, which was initially posted on May 1st 2018, is currently searching for enrollees. Approximately 75 individuals need to be recruited from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Meditation and Education That is Nurse Delivered for Symptom Management in Paroxysmal Atrial Fibrillation (PAF)

Paul Wang 2018. "Meditation and Education That is Nurse Delivered for Symptom Management in Paroxysmal Atrial Fibrillation (PAF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03834844.