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

Mindfulness Meditation and Patient Education for Symptom Management in Individuals With Atrial Fibrillation(AF): Do They Need to Be Offered Together?

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03834844

Acronym

MEND-AF2

Enrollment

Registered

2019-02-08

Start date

2018-05-01

Completion date

2025-12-31

Last updated

2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Atrial Fibrillation

Keywords

Symptom Management, Quality of Life, Anxiety

Brief summary

The aim of this project is to determine whether the entire intervention (Mindfulness meditation, AF education, and weekly phone visits) that is nurse delivered to individuals with paroxysmal atrial fibrillation is more effective than a combination, single or no intervention in the reduction of overall AF symptoms, anxiety, and negative illness perception; or the improvement of quality of life (QOL) and functional status.

Interventions

BEHAVIORALMeditation

Guided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks

OTHERAF Education

6 weekly education modules on topics related to AF

OTHERPhone Calls

Weekly phone call to discuss patient concerns or questions

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

2 x 2 factorial design

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Individuals with Symptomatic Paroxysmal Atrial Fibrillation 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

1. Diagnosed with low cardiac function (NYHA Class IV) 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

Design outcomes

Primary

Measure	Time frame	Description
Change from Baseline Atrial Fibrillation Symptom Burden and Symptom Severity Scores	Baseline (Initial), Post-Intervention (6 weeks)	Atrial Fibrillation Burden and Symptom Severity will be calculated from the patient-completed responses on the Atrial Fibrillation Symptom Severity Scale-Symptom Burden can range from 3.25 (minimally bothersome) to 30 (continuous symptomatic episodes) and is based on event frequency (1-10), duration (1.25-10), and global episode (1-10). Symptom severity is based on symptom specific subscale with range from 0(no symptoms) to 35 (severe symptoms).
Change from Baseline in AF Quality of Life Score	Baseline (Initial), Post-Intervention (6 weeks)	Quality of Life will be assessed using a patient completed questionnaire, Atrial Fibrillation Effect on Quality of Life Questionnaire. The AFEQT score is a combined score of 21 items (21-100) with a higher score representing greater QOL.

Secondary

Measure	Time frame	Description
Change from Baseline in Anxiety	Baseline (Initial), Post-Intervention (6 weeks)	Anxiety will be measured using the Cardiac Anxiety Questionnaire with a calculated score (0-72) and higher scores indicate greater heart focused anxiety.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026