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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05328856
Other study ID # VD
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 25, 2022
Est. completion date December 31, 2024

Study information

Verified date October 2023
Source Charite University, Berlin, Germany
Contact Miriam Rösner
Phone 03080505682
Email miriam.roesner@immanuelalbertinen.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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, 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2024
Est. primary completion date July 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Hansgrohe prototype
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

Locations

Country Name City State
Germany Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Blood pressure at rest (systolic and diastolic) Change from Baseline and after 4 weeks
Primary Hospital Anxiety and Depression Scale (HADS-D) Change Change from HADS-D Baseline, after 4 weeks and 12 weeks
Primary Self-Efficacy Scale (ASKU) Change Change from ASKU Baseline, after 4 weeks and 12 weeks
Primary WHO-Five Well-Being Index (WHO-5) Change Change from WHO-5 Baseline, after 4 weeks and 12 weeks
Primary Perceived Stress Scale (PSS-10) Change Change from PSS-10 Baseline, after 4 weeks and 12 weeks
Primary Flourishing Scale (FS-D) Change Change from FS-D Baseline, after 4 weeks and 12 weeks
Primary Insomnia Severity Index (ISI-D) Change Change from ISI-D Baseline, after 4 weeks and 12 weeks
Primary Short Form (SF-36) Change Change from SF-36 Baseline, after 4 weeks and 12 weeks
Primary 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
Primary Heart rate variability Change Change from Baseline and after 4 weeks
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