General PopulationNCT05328856
Effects of Vital Shower on Quality of Life, Immune Function, Cardiovascular Regulation and Well-being
A study testing Hansgrohe prototype/shower head in people with General Population, run by Charite University, Berlin, Germany at 1 site in Germany.
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 in a four-week daily application. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- General Population
- What is being tested?
- Hansgrohe prototype/shower head
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 25 May 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female and male patients between 18 and 70 years of age
Who cannot join
- 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
Show all 9Show fewer
- Severe mental illness
- Insufficiently treated dermatological diseases (e.g. neurodermatitis, psoriasis)
- Non-compatible sanitary shower or bath devices
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Berlin, State of Berlin, 14163
Andreas Michalsen, Prof. Dr., +49 (0)30 - 80505 - 691, a.michalsen@immanuel.de
About this study
Official title: 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.
- Conditions
- General Population
- Being tested
- Hansgrohe prototype/shower head
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hansgrohe prototype/shower headDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline and after 4 weeks
Blood pressure at rest (systolic and diastolic)
Measured: Change from Baseline and after 4 weeks
Hospital Anxiety and Depression Scale (HADS-D)
Change
Measured: Change from HADS-D Baseline, after 4 weeks and 12 weeks
Self-Efficacy Scale (ASKU)
Change
Measured: Change from ASKU Baseline, after 4 weeks and 12 weeks
WHO-Five Well-Being Index (WHO-5)
Change
Measured: Change from WHO-5 Baseline, after 4 weeks and 12 weeks
Perceived Stress Scale (PSS-10)
Change
Measured: Change from PSS-10 Baseline, after 4 weeks and 12 weeks
Flourishing Scale (FS-D)
Change
Measured: Change from FS-D Baseline, after 4 weeks and 12 weeks
Insomnia Severity Index (ISI-D)
Change
Measured: Change from ISI-D Baseline, after 4 weeks and 12 weeks
Short Form (SF-36)
Change
Measured: Change from SF-36 Baseline, after 4 weeks and 12 weeks
Von Zerssen somatic complaint list (B-LR and B-LR')
Change
Measured: Change from B-LR and B-LR' Baseline, after 4 weeks and 12 weeks
Heart rate variability
Change
Measured: Change from Baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start25 May 2022
- Primary completion30 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General PopulationStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328856
- Sponsor's protocol ID
- VD
- Status last verified
- Dec 2024
- First submitted
- 7 Apr 2022
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Randomised Controlled Trial on the Effects of Vital Shower (Hansgrohe) on Quality of Life, Immune Function, Cardiovascular Regulation and Well-being
- ClinicalTrials.gov ID
- NCT05328856
- Acronym / sponsor ID
- VD
- Conditions
- General Population
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vital shower | Active comparator | Device: Hansgrohe prototype/shower headParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female and male patients between 18 and 70 years of age
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hansgrohe prototype/shower headStart 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 | Device | Vital shower |
Primary outcome
Immunological laboratory
Time frame: 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
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
Change
Self-Efficacy Scale (ASKU)
Time frame: Change from ASKU Baseline, after 4 weeks and 12 weeks
Change
WHO-Five Well-Being Index (WHO-5)
Time frame: Change from WHO-5 Baseline, after 4 weeks and 12 weeks
Change
Perceived Stress Scale (PSS-10)
Time frame: Change from PSS-10 Baseline, after 4 weeks and 12 weeks
Change
Flourishing Scale (FS-D)
Time frame: Change from FS-D Baseline, after 4 weeks and 12 weeks
Change
Insomnia Severity Index (ISI-D)
Time frame: Change from ISI-D Baseline, after 4 weeks and 12 weeks
Change
Short Form (SF-36)
Time frame: Change from SF-36 Baseline, after 4 weeks and 12 weeks
Change
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
Change
Heart rate variability
Time frame: Change from Baseline and after 4 weeks
Change
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hansgrohe prototype/shower head in people with General Population, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Miriam Rösner (03080505682, miriam.roesner@immanuelalbertinen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological laboratory (time frame: Change from Baseline and after 4 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.