Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Length of hospital stay, Days to engraftment defined as absolute neutrophil count (ANC: segs + bands) greater
研究概览
简要总结
This randomized pilot clinical trial studies healing touch or usual care in improving quality of life in patients undergoing stem cell transplant. Healing touch may improve the quality of life of patients undergoing stem cell transplant.
详细描述
Primary Objectives:
I. To estimate the effects of healing touch (HT) vs usual care in the following clinical outcomes of stem cell transplant (SCT) patients; length of hospital stay, days to engraftment, and number of hospital readmissions during 100 days post-transplant.
II. To estimate changes in quality of life (QoL) which occur during hospitalization of SCT patients who receive HT vs. usual care.
III. To examine differences in effects of HT vs. usual care (UC) in patients receiving related allogeneic (Allo) transplant compared to those receiving autologous (Auto) transplant.
OUTLINE: Patients are randomized to 1 of 2 arms.
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
- •Currently undergoing autologous (auto) or related allogeneic (related allo) stem cell transplantation
- •Admitted to the University (U) Adult Blood and Bone Marrow Transplant Unit (UIBMTU) of the University of Iowa Hospitals and Clinic
- •Ability to provide written informed consent obtained prior to participation in the study and able to complete questionnaires
- •Pregnant woman who are eligible for stem cell transplant are included in this study
排除标准
- •Patients with any significant history of non-compliance to medical regimens, with inability to grant a reliable informed consent or unable to complete questionnaires
- •Patients with evidence of a significant psychiatric disorder by history that would prevent completion of the study will not be allowed to participate, i.e., schizophrenia, anxiety disorder, major depressive disorder and bipolar disorder
- •Diagnosis of dementia or other disease affecting cognitive function
- •Nursing women are excluded
结局指标
主要结局
Length of hospital stay, Days to engraftment defined as absolute neutrophil count (ANC: segs + bands) greater
时间窗: Up to 100 days
Changes in QoL (POMS-SF, FACT-BMT, CES-D)
时间窗: Baseline up to 100 days
Changes in levels of QoL measures before and after hospitalization will be compared using the paired t-test or the nonparametric paired sign test, if the assumption of normality is substantially violated.
次要结局
- Number of hospital readmissions(Up to 100 days)
研究者
Susan Lutgendorf
Professor
University of Iowa