UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027815 |
|---|---|
| Receipt number | R000031870 |
| Scientific Title | Effect of a warm hand bath on blood flow in the shoulder, skin and deep body temperature, autonomic nervous activity and subjective comfort in healthy women. |
| Date of disclosure of the study information | 2017/06/19 |
| Last modified on | 2018/05/30 10:19:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of a warm hand bath on blood flow in the shoulder, skin and deep body temperature, autonomic nervous activity and subjective comfort in healthy women.
Acronym
Effect of a warm hand bath on blood flow in the shoulder, skin and deep body temperature, autonomic nervous activity and subjective comfort in healthy women.
Scientific Title
Effect of a warm hand bath on blood flow in the shoulder, skin and deep body temperature, autonomic nervous activity and subjective comfort in healthy women.
Scientific Title:Acronym
Effect of a warm hand bath on blood flow in the shoulder, skin and deep body temperature, autonomic nervous activity and subjective comfort in healthy women.
Region
| Japan |
Condition
Condition
wemen
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to clarify the effects of a warm hand bath on blood flow of shoulder, skin and deep body temperature, autonomic nervous activity and subjective comfort in healthy Japanese women.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood flow of shoulder, skin and deep body temperature, autonomic nervous activity and subjective comfort.
Key secondary outcomes
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Participants were given a warm hand bath (water temperature, 40 deg C) for 10 min.The experimental protocol was set as resting for 20 min before the experiment, 10 min between conditions, and 90 min after the hand baths.
Interventions/Control_2
Control.
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
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy adult women.
Key exclusion criteria
A body mass index (BMI) over 25, menstruation during the experiment, exercising, eating, drinking, or smoking 2 h before the experiment (to avoid effects on autonomic nervous activity)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukiko KUDO |
Organization
Akita University Graduate School of Health Sciences
Division name
Basic Nursing
Zip code
Address
1-1-1, Hondo, Akita
TEL
+81-18-884-6505
yukiko@hs.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiko KUDO |
Organization
Akita University Akita University Graduate School of Health Sciences
Division name
Basic Nursing
Zip code
Address
1-1-1, Hondo, Akita
TEL
+81-18-884-6505
Homepage URL
yukiko@hs.akita-u.ac.jp
Sponsor or person
Institute
Akita University Graduate School of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
The Japanese Ministry of Education, Culture, Sports, Science, and Technology.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 06 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 19 | Day |
Last modified on
| 2018 | 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=R000031870
