Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-20 @ 6:09 PM
Study NCT ID:
NCT05328856
Status:
RECRUITING
Last Update Posted:
2025-03-06
First Post:
2022-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Vital Shower on Quality of Life, Immune Function, Cardiovascular Regulation and Well-being
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2022-04-07', 'studyFirstSubmitQcDate': '2022-04-13', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunological laboratory', 'timeFrame': 'Change from Baseline and after 4 weeks', 'description': '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'}, {'measure': 'Blood pressure at rest (systolic and diastolic)', 'timeFrame': 'Change from Baseline and after 4 weeks'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS-D)', 'timeFrame': 'Change from HADS-D Baseline, after 4 weeks and 12 weeks', 'description': 'Change'}, {'measure': 'Self-Efficacy Scale (ASKU)', 'timeFrame': 'Change from ASKU Baseline, after 4 weeks and 12 weeks', 'description': 'Change'}, {'measure': 'WHO-Five Well-Being Index (WHO-5)', 'timeFrame': 'Change from WHO-5 Baseline, after 4 weeks and 12 weeks', 'description': 'Change'}, {'measure': 'Perceived Stress Scale (PSS-10)', 'timeFrame': 'Change from PSS-10 Baseline, after 4 weeks and 12 weeks', 'description': 'Change'}, {'measure': 'Flourishing Scale (FS-D)', 'timeFrame': 'Change from FS-D Baseline, after 4 weeks and 12 weeks', 'description': 'Change'}, {'measure': 'Insomnia Severity Index (ISI-D)', 'timeFrame': 'Change from ISI-D Baseline, after 4 weeks and 12 weeks', 'description': 'Change'}, {'measure': 'Short Form (SF-36)', 'timeFrame': 'Change from SF-36 Baseline, after 4 weeks and 12 weeks', 'description': 'Change'}, {'measure': "Von Zerssen somatic complaint list (B-LR and B-LR')", 'timeFrame': "Change from B-LR and B-LR' Baseline, after 4 weeks and 12 weeks", 'description': 'Change'}, {'measure': 'Heart rate variability', 'timeFrame': 'Change from Baseline and after 4 weeks', 'description': 'Change'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['General Population']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female and male patients between 18 and 70 years of age\n\nExclusion Criteria:\n\n* Bad general condition\n* Serious acute or chronic comorbidity\n* Pregnancy and breast feeding period/ in the next 6 months\n* Participation in a clinical trial within the last 3 months before enrollment\n* Simultaneous participation in another clinical trial\n* Raynaud's disease or cold agglutinin disease\n* Severe mental illness\n* Insufficiently treated dermatological diseases (e.g. neurodermatitis, psoriasis)\n* Non-compatible sanitary shower or bath devices"}, 'identificationModule': {'nctId': 'NCT05328856', 'briefTitle': 'Effects of Vital Shower on Quality of Life, Immune Function, Cardiovascular Regulation and Well-being', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'An Randomised Controlled Trial on the Effects of Vital Shower (Hansgrohe) on Quality of Life, Immune Function, Cardiovascular Regulation and Well-being', 'orgStudyIdInfo': {'id': 'VD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vital shower', 'description': '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.', 'interventionNames': ['Device: Hansgrohe prototype/shower head']}, {'type': 'NO_INTERVENTION', 'label': 'Regular shower', 'description': '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': [{'name': 'Hansgrohe prototype/shower head', 'type': 'DEVICE', 'description': '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', 'armGroupLabels': ['Vital shower']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14163', 'city': 'Berlin', 'state': 'State of Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Andreas Michalsen, Prof. Dr.', 'role': 'CONTACT', 'email': 'a.michalsen@immanuel.de', 'phone': '+49 (0)30 - 80505 - 691'}], 'facility': 'Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Miriam Rösner', 'role': 'CONTACT', 'email': 'miriam.roesner@immanuelalbertinen.de', 'phone': '03080505682'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Andreas Michalsen', 'investigatorFullName': 'Andreas Michalsen', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}