Effects of Vital Shower on Quality of Life, Immune Function, Cardiovascular Regulation and Well-being
Not Applicable
Recruiting
- Conditions
- General Population
- Registration Number
- NCT05328856
- Lead Sponsor
- Charite University, Berlin, Germany
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Blood pressure at rest (systolic and diastolic) Change from Baseline and after 4 weeks 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
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
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
Heart rate variability Change from Baseline and after 4 weeks Change
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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Vital Shower's impact on immune function and cardiovascular regulation in healthy individuals?
How does Kneipp hydrotherapy with the Hansgrohe prototype compare to standard-of-care wellness interventions in terms of efficacy and safety?
Are there specific biomarkers that correlate with improved quality of life and well-being following Vital Shower therapy in the general population?
What adverse events have been reported in similar hydrotherapy trials and how are they managed in clinical practice?
What combination therapies or alternative devices show synergistic effects with hydrotherapy in enhancing immune and cardiovascular health?
Trial Locations
- Locations (1)
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
🇩🇪Berlin, Germany
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus🇩🇪Berlin, GermanyAndreas Michalsen, Prof. Dr.Contact+49 (0)30 - 80505 - 691a.michalsen@immanuel.de