UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043361 |
|---|---|
| Receipt number | R000049507 |
| Scientific Title | Examination of the effect of foot baths using commercially available carbonated bath salts on the hemodynamics of patients with heart disease |
| Date of disclosure of the study information | 2021/02/18 |
| Last modified on | 2021/08/29 14:25:40 |
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Basic information
Public title
Examination of the effect of foot baths using commercially available carbonated bath salts on the hemodynamics of patients with heart disease
Acronym
Examination of the effect of foot baths using commercially available carbonated bath salts on the hemodynamics of patients with heart disease
Scientific Title
Examination of the effect of foot baths using commercially available carbonated bath salts on the hemodynamics of patients with heart disease
Scientific Title:Acronym
Examination of the effect of foot baths using commercially available carbonated bath salts on the hemodynamics of patients with heart disease
Region
| Japan |
Condition
Condition
heart disease
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of hemodynamics on patients with heart disease by using a foot bath using a commercially available carbonated bath salt using subjective and objective indicators. The purpose of this is to provide information that contributes to the care methods implemented by supporters such as patients, nurses, and caregivers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in vital signs (blood pressure, pulse, SpO2, heart rate, electrocardiogram) from start to end of footbath compared to resting before implementation.
Key secondary outcomes
Changes in Body Composition Analyzer (In Body) measurements during the implementation period.
Changes in thermography measurements during the implementation period.
Changes in oil and moisture measurements before and after implementation.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults over 20 years of age with heart disease, AHA / ACC heart failure Stage C stage, NYHA I, II symptoms and LVEF 40% or higher.
Patients who can maintain a sitting position.
Patients who have permission to take a foot bath from their doctor.
Key exclusion criteria
Those who have been diagnosed with dementia, or who have an in-hospital CGA evaluation and have an MMSE of 23 points or less.
Those who are infusing circulatory drugs.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kikuko |
| Middle name | |
| Last name | Yamashita |
Organization
Shiga University of Medical Science Hospital
Division name
Nursing Department
Zip code
5202192
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
0775482111
tsunsan@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Kikuko |
| Middle name | |
| Last name | Yamashita |
Organization
Shiga University of Medical Science Hospital
Division name
Nursing Department
Zip code
5202192
Address
Seta Tsukinowa-cho, Otsu, Shiga
TEL
0775482111
Homepage URL
tsunsan@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shiga University of Medical Science Research Ethics Committee
Address
Seta Tsukinowa-cho, Otsu, Shiga
Tel
0775483576
hqrec@belle.shiga-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 02 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an exploratory study. The registration period is until December 31, 2021. Among the patients admitted to cardiology / cardiovascular surgery during the period, the researchers will give an oral explanation in writing and obtain written consent for patients who meet the eligibility criteria.
Management information
Registered date
| 2021 | Year | 02 | Month | 17 | Day |
Last modified on
| 2021 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049507
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
