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

General Population Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05328856
• Other study ID #: VD
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• General Population

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