An Randomised Controlled Trial on the Effects of Vital Shower (Hansgrohe) on Quality of Life, Immune Function, Cardiovascular Regulation and Well-being
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Hospital Anxiety and Depression Scale (HADS-D)
研究概览
简要总结
The aim of this exploratory randomized controlled clinical study is to evaluate the health-promoting effects of Kneipp hydrotherapy, in the form of the Vital Shower in a four-week daily application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female and male patients between 18 and 70 years of age
排除标准
- •Bad general condition
- •Serious acute or chronic comorbidity
- •Pregnancy and breast feeding period/ in the next 6 months
- •Participation in a clinical trial within the last 3 months before enrollment
- •Simultaneous participation in another clinical trial
- •Raynaud's disease or cold agglutinin disease
- •Severe mental illness
- •Insufficiently treated dermatological diseases (e.g. neurodermatitis, psoriasis)
- •Non-compatible sanitary shower or bath devices
结局指标
主要结局
Hospital Anxiety and Depression Scale (HADS-D)
时间窗: Change from HADS-D Baseline, after 4 weeks and 12 weeks
Change
Self-Efficacy Scale (ASKU)
时间窗: Change from ASKU Baseline, after 4 weeks and 12 weeks
Change
Blood pressure at rest (systolic and diastolic)
时间窗: Change from Baseline and after 4 weeks
Flourishing Scale (FS-D)
时间窗: Change from FS-D Baseline, after 4 weeks and 12 weeks
Change
Insomnia Severity Index (ISI-D)
时间窗: Change from ISI-D Baseline, after 4 weeks and 12 weeks
Change
Short Form (SF-36)
时间窗: Change from SF-36 Baseline, after 4 weeks and 12 weeks
Change
Immunological laboratory
时间窗: Change from Baseline and after 4 weeks
T-Cells (CD3), B-Cells (CD19), Natural Killer Cells (CD16), T-helper cells (CD4), cytotoxic T-cells (CD8), CD4/CD8 ratio, interleukin 4, interferon gamma
Von Zerssen somatic complaint list (B-LR and B-LR')
时间窗: Change from B-LR and B-LR' Baseline, after 4 weeks and 12 weeks
Change
WHO-Five Well-Being Index (WHO-5)
时间窗: Change from WHO-5 Baseline, after 4 weeks and 12 weeks
Change
Perceived Stress Scale (PSS-10)
时间窗: Change from PSS-10 Baseline, after 4 weeks and 12 weeks
Change
Heart rate variability
时间窗: Change from Baseline and after 4 weeks
Change
次要结局
未报告次要终点
研究者
Andreas Michalsen
Prof. Dr. Andreas Michalsen
Charite University, Berlin, Germany