UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058029 |
|---|---|
| Receipt number | R000066322 |
| Scientific Title | Effects of hand baths on autonomic nervous activity in people with diabetes |
| Date of disclosure of the study information | 2025/05/31 |
| Last modified on | 2025/05/30 18:38:27 |
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Basic information
Public title
Effects of hand baths on autonomic nervous activity in people with diabetes
Acronym
Effects of hand baths on autonomic nervous activity in people with diabetes
Scientific Title
Effects of hand baths on autonomic nervous activity in people with diabetes
Scientific Title:Acronym
Effects of hand baths on autonomic nervous activity in people with diabetes
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hand baths were administered to people with diabetes and those without diabetes to determine whether there were differences in autonomic nervous system activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
autonomic nervous activity
Key secondary outcomes
sleepiness
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
people with diabetes
Interventions/Control_2
people who do not have diabetes
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Diagnosed with diabetes for more than one year but less than ten years, and currently receiving medication.
Not diagnosed with diabetes by a medical institution.
Key exclusion criteria
Individuals diagnosed with cataracts. Individuals with autonomic nervous system disorders. Individuals with peripheral nerve disorders. Individuals with cardiovascular disease. Individuals currently taking medications that affect the autonomic nervous system. Individuals with brain disorders. Individuals experiencing abnormal sensations such as numbness or discomfort in the hands. Individuals unable to immerse their hands in warm water due to abnormal skin conditions on the hands.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | Iwane |
Organization
Wakayama Medical University
Division name
School of Health and Nursing Science
Zip code
641-0011
Address
580 Mikatsura, Wakayama City, Wakayama Prefecture
TEL
073-446-6700
iwane-na@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Iwane |
Organization
Wakayama Medical University
Division name
School of Health and Nursing Science
Zip code
641-0011
Address
580 Mikatsura, Wakayama City, Wakayama Prefecture
TEL
073-447-6700
Homepage URL
iwane-na@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University
Address
580 Mikatsura, Wakayama City, Wakayama Prefecture
Tel
0734466700
iwane-na@wakayama-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
| 2025 | Year | 05 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 30 | Day |
Last modified on
| 2025 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066322
