Short-term Effects of Sound-bed Music Therapy in Healthy Caregivers of a Hospital Oncology Ward (MTO_03) (MTO_03)
Short-term Effects of Live Sound-bed Music on Physiological and Psychological Parameters in Healthy Oncology Staff - A Randomized Controlled Trial With Crossover Design
The purpose of this study is to determine the effects of live sound-bed music on physiological and psychological parameters in staff of a hospital oncology ward.
研究概览
地位
完全的
干预/治疗
研究类型
介入性
注册 (预期的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Baden-Württemberg
-
Filderstadt、Baden-Württemberg、德国、70794
- Filderklinik
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- signed informed consent of the participant
- affiliation to the staff of the hospital oncology ward
Exclusion Criteria:
- insufficient knowledge of the German language
- alcohol, caffeine or nicotine less than 3 hours before the beginning
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Controll
No sound-bed intervention
|
|
|
实验性的：Music
live sound-bed music intervention
|
live sound-bed music intervention
|
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 |
|---|---|---|
|
Basler Mood Questionnaire (BBS)
大体时间：30 minutes
|
filled in by the participants four times (before and after the music intervention respectively no intervention)
|
30 minutes
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
additional questions addressing body warmth, subjective painlessness and general mental state
大体时间：30 minutes
|
filled in by the participants four times (before and after the music intervention respectively no intervention)
|
30 minutes
|
|
heart rate variability -Parameter (HRV)
大体时间：Physiological parameters are measured twice over a period of 2 hours.
|
Standard Deviation of Normal to Normal (heart rate) (SDNN)
|
Physiological parameters are measured twice over a period of 2 hours.
|
|
HRV-Parameter
大体时间：Physiological parameters are measured twice over a period of 2 hours.
|
Root Mean Square of the Successive Differences (RMSSD)
|
Physiological parameters are measured twice over a period of 2 hours.
|
|
HRV-Parameter
大体时间：Physiological parameters are measured twice over a period of 2 hours.
|
pNN50 (the proportion of NN50 divided by total number of NNs)
|
Physiological parameters are measured twice over a period of 2 hours.
|
|
HRV-Parameter
大体时间：Physiological parameters are measured twice over a period of 2 hours.
|
ratio low frequency to high frequency (LF/HF)
|
Physiological parameters are measured twice over a period of 2 hours.
|
|
HRV-Parameter
大体时间：Physiological parameters are measured twice over a period of 2 hours.
|
very low frequency (VLF)
|
Physiological parameters are measured twice over a period of 2 hours.
|
|
HRV-Parameter
大体时间：Physiological parameters are measured twice over a period of 2 hours.
|
NN50 (the number of pairs of successive NNs that differ by more than 50 ms)
|
Physiological parameters are measured twice over a period of 2 hours.
|
|
Hamilton Anxiety and Depression Scale
大体时间：filled in by the participants as baseline measurement at the beginning
|
filled in by the participants as baseline measurement at the beginning
|
|
|
Sense of Coherence (SOC-13)
大体时间：filled in by the participants as baseline measurement at the beginning
|
questionnaire
|
filled in by the participants as baseline measurement at the beginning
|
|
SF-12 Health Survey
大体时间：filled in by the participants as baseline measurement at the beginning
|
filled in by the participants as baseline measurement at the beginning
|
|
|
Electromyography (EMG)
大体时间：Physiological parameters are measured twice over a period of 2 hours.
|
Electromyography of the shoulder muscles
|
Physiological parameters are measured twice over a period of 2 hours.
|
|
Skin temperature
大体时间：Physiological parameters are measured twice over a period of 2 hours.
|
Physiological parameters are measured twice over a period of 2 hours.
|
|
|
skin conductance
大体时间：Physiological parameters are measured twice over a period of 2 hours.
|
skin conductance measured at the fingertip
|
Physiological parameters are measured twice over a period of 2 hours.
|
|
Cortisol
大体时间：20 minutes
|
via the saliva of the participants before and after the music intervention respectively no intervention
|
20 minutes
|
|
Pulse-Transit-Time (PTT)
大体时间：Physiological parameters are measured twice over a period of 2 hours
|
Pulse-Transit-Time (ms)
|
Physiological parameters are measured twice over a period of 2 hours
|
|
Perfusion-Index (PI)
大体时间：Physiological parameters are measured twice over a period of 2 hours
|
Perfusion-Index
|
Physiological parameters are measured twice over a period of 2 hours
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jan Vagedes, Dr.、ARCIM-Institute
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年9月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2014年9月9日
首先提交符合 QC 标准的
2014年10月1日
首次发布 (估计)
2014年10月3日
研究记录更新
最后更新发布 (估计)
2015年1月13日
上次提交的符合 QC 标准的更新
2015年1月12日
最后验证
2015年1月1日
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.