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

An Randomised Controlled Trial on the Effects of Vital Shower (Hansgrohe) 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.

Study Overview

• Status: Recruiting
• Conditions: General Population
• Intervention / Treatment: Device: Hansgrohe prototype/shower head

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miriam Rösner; Phone Number: 03080505682; Email: miriam.roesner@immanuelalbertinen.de

Study Locations

• Germany
  • Berlin, Germany, 14163
    • Recruiting
    • Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
    • Contact: Andreas Michalsen, Prof. Dr.; Phone Number: +49 (0)30 - 80505 - 691; Email: a.michalsen@immanuel.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Regular shower; 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.
Active Comparator: Vital shower; Participants receive a prototype/shower head from Hansgrohe and training including a handout. After installation, participants are asked to shower daily for four weeks according to a predefined shower protocol.	Device: Hansgrohe prototype/shower head; Start 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Estimated): July 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: VD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No