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

NCT05328856 | Recruiting

• 1 other identifier: VD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

General Population

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (2)

Vital shower

ACTIVE COMPARATOR

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

Regular shower

NO INTERVENTION

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.

Interventions

Hansgrohe prototype/shower head DEVICE

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

Vital shower

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female and male patients between 18 and 70 years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Berlin, State of Berlin, 14163, Germany

RECRUITING

Central Study Contacts

Miriam Rösner

CONTACT

03080505682; miriam.roesner@immanuelalbertinen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Andreas Michalsen

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: May 25, 2022
• Primary Completion: July 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 6, 2025

Record last verified: 2024-12

Locations

DE (1)