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

Not Applicable

Recruiting

• Conditions: General Population
• Interventions: Device: Hansgrohe prototype

• Registration Number: NCT05328856
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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 in a four-week daily application.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-14
• Study Start: 2022-05-25
• Status Verified: 2024-12
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-07-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vital shower	Hansgrohe prototype	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus; 🇩🇪 Berlin, Germany