Effects of Vital Shower on Quality of Life, Immune Function, Cardiovascular Regulation and Well-being

Study Overview
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Brief Summary
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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, a variation of the alternating warm and cold showers, in a four-week daily application. The hydrotherapy will be carried out in the home environment using a shower prototype from Hansgrohe.

Official Title
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An Randomised Controlled Trial on the Effects of Vital Shower (Hansgrohe Prototype) on Quality of Life, Immune Function, Cardiovascular Regulation and Well-being

Conditions
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General Population

Intervention / Treatment
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* Device: Hansgrohe prototype


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vital shower<br>Participants receive the installation of a shower prototype from Hansgrohe and training including a handout. After installation, participants are asked to shower daily for four weeks according to a predefined shower protocol with alternating warm and cold water application. | Device: Hansgrohe prototype<br>* Start of the shower with warm comfort temperature and usual body cleansing. Then the Vital shower is carried out with a mixing function 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<br>|
| No Intervention: Regular shower<br>Participants are advised not to change their showering behaviour; at the end of the study, the participants receive an offer of a shower head for free. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological laboratory | 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 | Change from Baseline and after 4 weeks | 
| Blood pressure at rest (systolic and diastolic) |  | Change from Baseline and after 4 weeks | 
| Hospital Anxiety and Depression Scale (HADS-D) | Change | Change from HADS-D Baseline, after 4 weeks and 12 weeks | 
| Self-Efficacy Scale (ASKU) | Change | Change from ASKU Baseline, after 4 weeks and 12 weeks | 
| WHO-Five Well-Being Index (WHO-5) | Change | Change from WHO-5 Baseline, after 4 weeks and 12 weeks | 
| Perceived Stress Scale (PSS-10) | Change | Change from PSS-10 Baseline, after 4 weeks and 12 weeks | 
| Flourishing Scale (FS-D) | Change | Change from FS-D Baseline, after 4 weeks and 12 weeks | 
| Insomnia Severity Index (ISI-D) | Change | Change from ISI-D Baseline, after 4 weeks and 12 weeks | 
| Short Form (SF-36) | Change | Change from SF-36 Baseline, after 4 weeks and 12 weeks | 
| Von Zerssen somatic complaint list (B-LR and B-LR') | Change | Change from B-LR and B-LR' Baseline, after 4 weeks and 12 weeks | 
| Heart rate variability | Change | Change from Baseline and after 4 weeks |