Pilot Study of Massage Therapy to Improve Self-efficacy in Patients With Left-ventricular Device
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change in Self-Efficacy for Managing Chronic Disease 6-item Scale from Baseline to Repeat Visits
研究概览
简要总结
This pilot study evaluates the role of massage therapy to improve self-efficacy in patients with advanced heart failure who have recently received a left-ventricular assist device. In addition to usual care, half of the volunteer patients will receive a massage at regular clinic visits and half will not receive any massage.
详细描述
Patients with advanced heart failure who undergo left-ventricular assist device (LVAD) implantation may experience notable physical and/or emotional distress associated with this lifestyle-changing procedure. Furthermore, these patients are faced with the task of coping with the trauma of surgery, creating new self-care routines, and learning to live with a lifesaving mechanical device that must always be connected to a power source.The immediate weeks and months after LVAD implantation are a critical period to lower physical and emotional distress and to influence patient coping and adaptation. In small studies, massage therapy has been increasingly used to improve patient self-efficacy and coping. In this pilot study, we investigate whether regularly scheduled massages delivered in the clinic setting improve self-efficacy and coping in this select patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •capacitated, at least 18 years of age, received LVAD implant during last hospital admission
排除标准
- •incapacitated, non-English speaking, negative pressure isolation, unstable spine, very low serum platelets (<10,000/uL), received massage in 30 days prior to enrollment
结局指标
主要结局
Change in Self-Efficacy for Managing Chronic Disease 6-item Scale from Baseline to Repeat Visits
时间窗: 1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion
The Self-Efficacy for Managing Chronic Disease 6-item Scale is a psychometric scale that asks the subject 6 questions regarding confidence managing aspects of the chronic illness (fatigue, physical discomfort, emotional distress, non-pain symptoms, medication adherence, completing assigned health care related tasks). Subjects respond to each question on a Likert scale from zero to 10 (zero="not confident at all"; 10="totally confident"). The score for the scale is the mean of the composite scores of the 6 Likert scales.
次要结局
- Change in score on National Comprehensive Cancer Network Distress Thermometer from baseline to repeat visits(1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion)
- Change in score on Brief COPE Inventory from baseline to repeat visits(1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion)
- Change in score on McGill Quality of Life Scale (Revised) from baseline to repeat visits(1) Baseline; 2) after week 4; 3) after week 8; 4) 1 month post completion)
研究者
Hunter Groninger
Investigator
Medstar Health Research Institute