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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027815
Receipt No. R000031870
Official scientific title of the study 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 2017/06/19

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Basic information
Official scientific title of the study 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.
Title of the study (Brief 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.
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 Yukiko KUDO
Organization Akita University Graduate School
Division name Health Sciences
Address 1-1-1, Hondo, Akita
TEL +81-18-884-6505
Email yukiko@hs.akita-u.ac.jp

Public contact
Name of contact person Yukiko KUDO
Organization Akita University Graduate School
Division name Health Sciences
Address 1-1-1, Hondo, Akita
TEL +81-18-884-6505
Homepage URL
Email yukiko@hs.akita-u.ac.jp

Sponsor
Institute The Japanese Ministry of Education, Culture, Sports, Science, and Technology.
Institute
Department

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)

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

Progress
Recruitment status Terminated
Date of protocol fixation
2015 Year 01 Month 27 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2017 Year 06 Month 19 Day
Last modified on
2017 Year 06 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031870

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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