Cardiac Arrhythmias
Conditions
Keywords
Randomized Clinical Control Trial, Complementary and Alternative Medicine, Yoga, Electrophysiology, Implantable Cardioverter Defibrillator, Psychosocial, Anxiety, Self-Compassion, Anti-Tachycardia Pacing Events
Brief summary
Psychosocial risks are significant in the management of patients with cardiovascular disease and implantable cardioverter defibrillators (ICD) devices. This is a randomized, controlled, clinical study. The hypothesis is that adapted yoga (vs. usual care) will significantly reduce psychosocial risks (e.g. anxiety and depression symptoms) and improve the quality of life in ICD patients. The specialized, real-time data, collected by the device provides a unique look at the electrophysiological parameters of each patient's heart.
Detailed description
All intervention data will be analyzed to determine the statistical significance of the data, and to accept or reject the hypothesis. In addition, the researcher will conduct supplemental interviews with patients who have lived with the implantable cardioverter defibrillator (ICD) device for at least six months and who are not in the intervention. The qualitative data gathered from these interviews will document concepts of illness and healing and general beliefs about mind-body interventions.
Interventions
BEHAVIORALAdapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients
A weekly 80-minute standardized, repeatable adapted Yoga program designed for recipients of Implantable Cardioverter Defibrillators, including a 30-minute home practice CD.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Receipt of Implantable Cardioverter Defibrillator for 6 weeks or more * Must be 18 or more years of age
Exclusion criteria
* Patients requiring more than 48 hours of hospitalization for implantation * Mental Incompetence (Dementia) * Physician's contra-indication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Florida Shock Anxiety Scale (FSAS) | Baseline | A 10-item list which measures patient fears about implantable cardioverter defibrillator shock. |
| Self-Compassion Scale | Baseline | A 26-item self-report scale that measures self-kindness, self-judgement, common humanity, isolation, mindfulness and over-identification. |
| The number of device-initiated ventricular defibrillations as recorded by their ICD device | Baseline | A record of device firings from the Implantable Cardioverter Defibrillator (ICD) device data. |
| The number of anti-tachycardia pacing events among participants as recorded by their ICD device | Baseline | As measured by each ICD device, the number of times that the device therapeutically paced the heart faster than its intrinsic rate, known as anti-tachycardia pacing (ATP), was recorded for each participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Florida Patient Acceptance Survey (FPAS) | Baseline | An 18-item list which measures patient acceptance of implantable cardiac device therapy. |
| Center for Epidemiologic Study Depression Scale (CES-D) | Baseline | A 20-item list which is a self-report depression scale for research in the general population. |
| Interpersonal Support Evaluation | Baseline | A 16-item self-report list designed to measure belonging, self-esteem, appraisal, and other concrete areas of social support. |
| Hospitalizations | Baseline | Medical Chart Review of cardiac and non-cardiac hospitalizations. |
| Expression Manipulation Test | Baseline | A 31-item list which tests personal and situational cue responsiveness. |
| Medications | Baseline | Review of medication use (cardiac, anti-arrhythmia, anti-depression and anti-anxiety medications) from Medical Charts. |
| Co-morbidities | Baseline | Medical chart review for co-existing morbidities. |
| Ejection Fraction | Baseline | Cardiac ejection fraction measured from Electro-cardiogram (EKG). |
| Atrial Fibrillation | Baseline | A record of atrial events recorded in the Implantable Cardioverter Defibrillator (ICD) device data, and in Medical Chart Review. |
| Implantation Status | Baseline | Primary prevention and secondary prevention data from Medical Chart Review. |
| Pennebaker Inventory | Baseline | A 54-item list which tests psychological responses to physical symptoms. |
| State-Trait Anxiety Inventory (STAI) | Baseline | A 30-item self report scale emphasizing dispositional states (anxiety). |
| Positive Health Expectation Scale | Baseline | A 7-item list which measures positive expectations to predict health after heart transplantation. |
Outcome results
None listed