Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant
研究概览
详细说明
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.
ARM I: Patients receive daily HT sessions comprising pain drain, chakra connection, magnetic clearing, and mind clearing over 30 minutes from day 1 until 2 days before discharge from the hospital.
ARM II: Patients receive routine nursing care from doctors and nurses from day 1 until 2 days before discharge from the hospital.
After completion of study treatment, patients are followed up for 100 days.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
Iowa
-
Iowa City、Iowa、美国、52242
- University of Iowa Hospitals and Clinics
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm 1 (healing touch)
Patients receive daily HT sessions comprising pain drain, chakra connection, magnetic clearing, and mind clearing over 30 minutes from day 1 until 2 days before discharge from the hospital (therapeutic touch). Interventions: therapeutic touch, quality-of-life assessment, and questionnaire administration |
辅助研究
辅助研究
其他名称：
receiving healing touch
其他名称：
|
|
有源比较器：Arm II (usual care)
Patients receive routine nursing care from doctors and nurses from day 1 until 2 days before discharge from the hospital. Interventions: quality-of-life assessment, and questionnaire administration |
辅助研究
辅助研究
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Length of hospital stay, Days to engraftment defined as absolute neutrophil count (ANC: segs + bands) greater
大体时间：Up to 100 days
|
Up to 100 days
|
|
|
Changes in QoL (POMS-SF, FACT-BMT, CES-D)
大体时间：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.
|
Baseline up to 100 days
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Number of hospital readmissions
大体时间：Up to 100 days
|
Up to 100 days
|
合作者和调查者
调查人员
- 首席研究员：Susan K Lutgendorf, PhD、University of Iowa
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.