Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Berlin, State of Berlin, 14163, Germany
Location status: Recruiting
Recruiting
NCT Number: NCT05328856
Effects of Vital Shower on Quality of Life, Immune Function, Cardiovascular Regulation and Well-being
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–70 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Hansgrohe prototype/shower head
DeviceStart 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
Primary outcomes
-
Immunological laboratory
Time frame: 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)
Time frame: Change from Baseline and after 4 weeks
-
Hospital Anxiety and Depression Scale (HADS-D)
Time frame: Change from HADS-D Baseline, after 4 weeks and 12 weeks
Change
-
Self-Efficacy Scale (ASKU)
Time frame: Change from ASKU Baseline, after 4 weeks and 12 weeks
Change
-
WHO-Five Well-Being Index (WHO-5)
Time frame: Change from WHO-5 Baseline, after 4 weeks and 12 weeks
Change
-
Perceived Stress Scale (PSS-10)
Time frame: Change from PSS-10 Baseline, after 4 weeks and 12 weeks
Change
-
Flourishing Scale (FS-D)
Time frame: Change from FS-D Baseline, after 4 weeks and 12 weeks
Change
-
Insomnia Severity Index (ISI-D)
Time frame: Change from ISI-D Baseline, after 4 weeks and 12 weeks
Change
-
Short Form (SF-36)
Time frame: Change from SF-36 Baseline, after 4 weeks and 12 weeks
Change
-
Von Zerssen somatic complaint list (B-LR and B-LR')
Time frame: Change from B-LR and B-LR' Baseline, after 4 weeks and 12 weeks
Change
-
Heart rate variability
Time frame: Change from Baseline and after 4 weeks
Change
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Charite University, Berlin, Germany
Other
Registry information
Official study title
An Randomised Controlled Trial on the Effects of Vital Shower (Hansgrohe) on Quality of Life, Immune Function, Cardiovascular Regulation and Well-being
Important dates
- Study start
- 2022
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Apr 14, 2022
- Registry last updated
- Mar 6, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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