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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05328856

Collaborator

(none)

Enrollment

Location

Arms

8.2

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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, a variation of the alternating warm and cold showers, in a four-week daily application. The hydrotherapy will be carried out in the home environment using a shower prototype from Hansgrohe.

Condition or Disease	Intervention/Treatment	Phase
General Population	Device: Hansgrohe prototype	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

An Randomised Controlled Trial on the Effects of Vital Shower (Hansgrohe Prototype) on Quality of Life, Immune Function, Cardiovascular Regulation and Well-being

Anticipated Study Start Date :

Apr 25, 2022

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vital shower 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.	Device: Hansgrohe prototype Start of the shower with warm comfort temperature and usual body cleansing. Then the Vital shower is carried out with a mixing function 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
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.

Arm

Intervention/Treatment

Active Comparator: Vital shower

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.

Device: Hansgrohe prototype

Start of the shower with warm comfort temperature and usual body cleansing. Then the Vital shower is carried out with a mixing function 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

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.

Outcome Measures

Primary Outcome Measures

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
Blood pressure at rest (systolic and diastolic) [Change from Baseline and after 4 weeks]
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
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
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
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
Heart rate variability [Change from Baseline and after 4 weeks]
Change

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus	Berlin		Germany	14163

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andreas Michalsen, Prof. Dr. Andreas Michalsen, Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT05328856

Other Study ID Numbers:

First Posted:

Apr 14, 2022

Last Update Posted:

Apr 14, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 14, 2022