General Population
Conditions
Brief summary
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.
Interventions
DEVICEHansgrohe prototype/shower head
Start of the shower with warm comfort temperature and usual body cleansing. Then the Vital shower is carried out for a total of 3-5 minutes, followed optionally by another warm shower with 30 seconds or direct transition to a classic cold shower for 30- 60 seconds
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Female and male patients between 18 and 70 years of age
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Von Zerssen somatic complaint list (B-LR and B-LR') | Change from B-LR and B-LR' Baseline, after 4 weeks and 12 weeks | Change |
| Heart rate variability | Change from Baseline and after 4 weeks | Change |
| Immunological laboratory | 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 |
| Blood pressure at rest (systolic and diastolic) | Change from Baseline and after 4 weeks | — |
| Hospital Anxiety and Depression Scale (HADS-D) | Change from HADS-D Baseline, after 4 weeks and 12 weeks | Change |
| Self-Efficacy Scale (ASKU) | Change from ASKU Baseline, after 4 weeks and 12 weeks | Change |
| WHO-Five Well-Being Index (WHO-5) | Change from WHO-5 Baseline, after 4 weeks and 12 weeks | Change |
| Perceived Stress Scale (PSS-10) | Change from PSS-10 Baseline, after 4 weeks and 12 weeks | Change |
| Flourishing Scale (FS-D) | Change from FS-D Baseline, after 4 weeks and 12 weeks | Change |
| Insomnia Severity Index (ISI-D) | Change from ISI-D Baseline, after 4 weeks and 12 weeks | Change |
| Short Form (SF-36) | Change from SF-36 Baseline, after 4 weeks and 12 weeks | Change |
Countries
Germany
Contacts
Primary ContactMiriam Rösner
Outcome results
None listed