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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021442
Receipt No. R000024730
Scientific Title Influence of continuous public hot spring facility "Tokotome no Sato Ichishi" usage on sense of well-being in community residents
Date of disclosure of the study information 2016/03/11
Last modified on 2017/07/18

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Basic information
Public title Influence of continuous public hot spring facility "Tokotome no Sato Ichishi" usage on sense of well-being in community residents
Acronym Influence of continuous public hot spring facility usage on sense of well-being in community residents
Scientific Title Influence of continuous public hot spring facility "Tokotome no Sato Ichishi" usage on sense of well-being in community residents
Scientific Title:Acronym Influence of continuous public hot spring facility usage on sense of well-being in community residents
Region
Japan

Condition
Condition healthy subject
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 One type of feature that can serve as such a regional hub is public hot spring facilities. We therefore attempt to establish the efficacy of continuous usage of public hot spring facilities for creating a sense of well-being as a regional hub for health promotion and social capital activation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Salivary cortisol, SF-8, and Visual Analog Scale night and day for duration of intervention
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Trial subjects in city residents are divided into two equal groups that used the hot springs either continuously or non-continuously. We measure salivary cortisol levels as an index of autonomic nervous activity, and assessed health-related quality of life (HRQOL, SF-36), and emotional scores (using a visual analog scale) using a before and after trial method and crossover methods.

Intervention1(use a public hot spring facility for a week continuously), no wash-out period, Intervention2(non-use a public hot spring facility for a week)
Interventions/Control_2 Trial subjects in city residents are divided into two equal groups that used the hot springs either continuously or non-continuously.

Intervention 1 (non-use a public hot spring facility for a week), no wash-out period, Intervention 2 (use a public hot spring facility for a week continuously)
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
15 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Healthy male and female
Key exclusion criteria Not have serious underlying disease
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chihiro MIWA
Organization Aichi Medical College for Physical and Occupational Therapy
Division name Department of rehabilitation
Zip code
Address 519 Ichiba, Kiyosu, Aichi
TEL 052-409-3311
Email aichi@yuai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasunori MORI
Organization Mie Prefecture Health and Environment Research Institute
Division name Department of hygienic sciences
Zip code
Address 3684-11 Sakura-cho, Yokkaichi, Mie
TEL 059-329-3800
Homepage URL
Email hokan@pref.mie.jp

Sponsor
Institute Mie Prefecture Health and Environment Research Institute
Institute
Department

Funding Source
Organization Mie Prefecture
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
Address
Tel
Email

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
2016 Year 03 Month 11 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 02 Month 02 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 02 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
2016 Year 03 Month 11 Day
Last modified on
2017 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024730

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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