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This is a trial to examine the effects of meditation on the incidence of ventricular arrhythmias and the psychological profiles in patients with implanted cardiac defibrillators.
We wish to test the following hypotheses:
This is a single center, investigator-initiated, randomized, controlled trial to examine the effects of meditation on the incidence of ventricular arrhythmias and the psychological profiles in patients with implanted cardiac defibrillators and cardiac resynchronization devices. The former are used to protect patients against cardiac fibrillation and the latter for synchronizing the contractions of the two ventricles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meditation Cohort | Experimental | 25 patients will be given instruction in vipassana meditation. Vipassana meditation is thought to reduce the incidence of atrial and ventricular arrhythmias in patients with congestive heart failure, and improve their overall psychological profile. |
|
| Standard Care | Active Comparator | 25 patients will receive current standard of care to manage their congestive heart failure, implanted cardiac devices, and psychological health. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vipassana Meditation practice and instruction | Behavioral | 2-3 instructed meditation sessions per week in addition to standard medical care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in ventricular arrhythmias and incidence of sudden cardiac death secondary to ventricular arrhythmias. | 3 month interval | |
| Reduction of norepinephrine levels within the meditation assigned group resulting in improved quality of life. | 3 month intervals | |
| Improved psychological profile of patients with CHF due to enhanced vitality and improved coping mechanisms resulting from participating in focused meditation. | 3 month intervals | |
| Increase in heart rate variability for patients participating in vipassana meditation training. | 3 month intervals |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uma Srivatsa, MD | University of California, Davis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| D019122 | Meditation |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
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| Standard Medical Care | Other | Standard medical care for patients with congestive heart failure plus implanted cardiac defibrillators. |
|
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| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
| D012064 | Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |