The Efficacy of Adapted Yoga in Managing Psychosocial Risk in Implantable Cardioverter Defibrillator (ICD) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 主要终点
- Florida Shock Anxiety Scale (FSAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receipt of Implantable Cardioverter Defibrillator for 6 weeks or more
- •Must be 18 or more years of age
排除标准
- •Patients requiring more than 48 hours of hospitalization for implantation
- •Mental Incompetence (Dementia)
- •Physician's contra-indication
结局指标
主要结局
Florida Shock Anxiety Scale (FSAS)
时间窗: End of Intervention (8 weeks)
A 10-item list which measures patient fears about implantable cardioverter defibrillator shock.
Self-Compassion Scale
时间窗: End of Intervention (8 weeks)
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
时间窗: Six month follow-up
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
时间窗: Six month follow-up
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.
次要结局
- State-Trait Anxiety Inventory (STAI)(End of Intervention (8 weeks))
- Expression Manipulation Test(End of Intervention (8 weeks))
- Pennebaker Inventory(End of Intervention (8 weeks))
- Positive Health Expectation Scale(End of Intervention (8 weeks))
- Florida Patient Acceptance Survey (FPAS)(End of Intervention (8 weeks))
- Center for Epidemiologic Study Depression Scale (CES-D)(End of Intervention (8 weeks))
- Interpersonal Support Evaluation(End of Intervention (8 weeks))
- Hospitalizations(Six month follow-up)
- Implantation Status(Baseline)
- Medications(Six month follow-up)
- Co-morbidities(Six month follow-up)
- Ejection Fraction(Six month follow-up)
- Atrial Fibrillation(Six month follow up)
研究者
Stefanie Toise
Principal Investigator
Yale University