UMIN-CTR Clinical Trial

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 of Health Sciences
Division name	Basic Nursing
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 Akita University Graduate School of Health Sciences
Division name	Basic Nursing
Address	1-1-1, Hondo, Akita
TEL	+81-18-884-6505
Homepage URL
Email	yukiko@hs.akita-u.ac.jp

Sponsor
Institute	Akita University Graduate School of Health Sciences
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	Completed
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	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031870