Recruiting NCT05328856
Effects of Vital Shower on Quality of Life, Immune Function, Cardiovascular Regulation and Well-being
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hansgrohe prototype/shower head.
- Who it may be relevant to
- Registry conditions: General Population. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Randomised Controlled Trial on the Effects of Vital Shower (Hansgrohe) on Quality of Life, Immune Function, Cardiovascular Regulation and Well-being
Overview
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.
Interventions
- 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
Primary outcome measures
- Immunological laboratory [Time frame: Change from Baseline and after 4 weeks]
- Blood pressure at rest (systolic and diastolic) [Time frame: Change from Baseline and after 4 weeks]
- Hospital Anxiety and Depression Scale (HADS-D) [Time frame: Change from HADS-D Baseline, after 4 weeks and 12 weeks]
- Self-Efficacy Scale (ASKU) [Time frame: Change from ASKU Baseline, after 4 weeks and 12 weeks]
- WHO-Five Well-Being Index (WHO-5) [Time frame: Change from WHO-5 Baseline, after 4 weeks and 12 weeks]
- Perceived Stress Scale (PSS-10) [Time frame: Change from PSS-10 Baseline, after 4 weeks and 12 weeks]
- Flourishing Scale (FS-D) [Time frame: Change from FS-D Baseline, after 4 weeks and 12 weeks]
- Insomnia Severity Index (ISI-D) [Time frame: Change from ISI-D Baseline, after 4 weeks and 12 weeks]
- Short Form (SF-36) [Time frame: Change from SF-36 Baseline, after 4 weeks and 12 weeks]
- Von Zerssen somatic complaint list (B-LR and B-LR') [Time frame: Change from B-LR and B-LR' Baseline, after 4 weeks and 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Germany · 1 center
- Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus — Berlin
Identifiers
NCT: NCT05328856 · VD