UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001433 |
|---|---|
| Receipt number | R000001742 |
| Scientific Title | Effects of bedrock bathing (Ganbanyoku) on body and psychological states |
| Date of disclosure of the study information | 2008/10/17 |
| Last modified on | 2011/04/21 13:16:50 |
* 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
Effects of bedrock bathing (Ganbanyoku) on body and
psychological states
Acronym
Shizuoka Ganbanyoku Study
Scientific Title
Effects of bedrock bathing (Ganbanyoku) on body and
psychological states
Scientific Title:Acronym
Shizuoka Ganbanyoku Study
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Medicine in general | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects of bedrock bathing on body and psychological states
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood pressure, pulse, POMS(mood), STAI(anxiety) and others
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
bedrock bathing
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy volunteer
Key exclusion criteria
subjects who are prohibited bath by physicians
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Hayasaka |
Organization
Hamamatsu University School of Medicine
Division name
Depf. of Community Health and Preventive Medicine
Zip code
Address
1-20-1 Handayama Higashiku Hamamatsu
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hamamatsu University School of Medicine
Division name
Depf. of Community Health and Preventive Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Depf. of Community Health and Preventive Medicine,
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fujinetsusetsubi
Organization
Division
Category of Funding Organization
Profit organization
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
| 2008 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
This uncontrolled intervention study explored the effects of stone spa use on the psychological states of
women. Sixty-eight female volunteers (mean age 37.5 years (standard deviation 14.8)) recruited at
a women-only stone spa facility participated in the study. They completed the short-form Profile of
Moods States (POMS) and the State-Trait Anxiety Inventory (STAI) before and after stone spa use in order
to determine changes in mood and anxiety states. Six factors relating to mood were measured using the
POMS: Tension&Anxiety, Depression&Dejection, Anger&Hostility, Vigor, Fatigue, and Confusion. The two
anxiety concepts of state anxiety and trait anxiety were also measured. The scores for Tension&Anxiety
and Anger&Hostility and both anxiety measures were improved statistically after stone spa use. Stone spa
use shows considerable promise for improving mood and reducing anxiety. Since this study was
a descriptive, prospective and uncontrolled intervention study, further investigation of these promising
findings is warranted.
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
| 2007 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Hayasaka S, Tsutsumi A, Noda N, Murata C, Ojima T: Effects of Stone Spa (Ganban-yoku) on Psychological States. Complement Ther Clin Pract 15: 129-32. 2009.
Management information
Registered date
| 2008 | Year | 10 | Month | 16 | Day |
Last modified on
| 2011 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001742
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
