UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032808 |
|---|---|
| Receipt number | R000037425 |
| Scientific Title | Effect of touching brushing wood (Uzukuri) of Japanese cedar with the sole of the foot. |
| Date of disclosure of the study information | 2018/05/31 |
| Last modified on | 2020/09/08 12:03:49 |
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Basic information
Public title
Effect of touching brushing wood (Uzukuri) of Japanese cedar with the sole of the foot.
Acronym
Effect of touching brushing wood (Uzukuri) of Japanese cedar with the sole of the foot.
Scientific Title
Effect of touching brushing wood (Uzukuri) of Japanese cedar with the sole of the foot.
Scientific Title:Acronym
Effect of touching brushing wood (Uzukuri) of Japanese cedar with the sole of the foot.
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to clarify the effect of touching brushing wood (Uzukuri) of Japanese cedar with the sole of the foot in female university students, using psychological and physiological indicators.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Near infrared spectroscopy
2) Heart rate variability
3) Heart rate
Key secondary outcomes
1) Profile of Mood State
2) Modified semantic differential method
3) Kwansei Gakuin (KG) daily life questionnaire
4) Trait Anxiety of State-Trait Anxiety Inventory
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Tactile stimulation with brushing wood (Uzukuri) of Japanese cedar (90 s) -> Washout period -> Tactile stimulation with sanding wood of Japanese cedar (90 s) -> Washout period -> Tactile stimulation with marble (90 s)
Interventions/Control_2
Tactile stimulation with brushing wood (Uzukuri) of Japanese cedar (90 s) -> Washout period -> Tactile stimulation with marble (90 s) -> Washout period -> Tactile stimulation with sanding wood of Japanese cedar (90 s)
Interventions/Control_3
Tactile stimulation with sanding wood of Japanese cedar (90 s) -> Washout period -> Tactile stimulation with brushing wood (Uzukuri) of Japanese cedar (90 s) -> Washout period -> Tactile stimulation with marble (90 s)
Interventions/Control_4
Tactile stimulation with sanding wood of Japanese cedar (90 s) -> Washout period -> Tactile stimulation with marble (90 s) -> Washout period -> Tactile stimulation with brushing wood (Uzukuri) of Japanese cedar (90 s)
Interventions/Control_5
Tactile stimulation with marble (90 s) -> Washout period -> Tactile stimulation with brushing wood (Uzukuri) of Japanese cedar (90 s) -> Washout period -> Tactile stimulation with sanding wood of Japanese cedar (90 s)
Interventions/Control_6
Tactile stimulation with marble (90 s) -> Washout period -> Tactile stimulation with sanding wood of Japanese cedar (90 s) -> Washout period -> Tactile stimulation with brushing wood (Uzukuri) of Japanese cedar (90 s)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
Healthy person
Key exclusion criteria
1) Subjects who are in a poor physical condition
2) Subjects who have a respiratory illness
3) Subjects deemed inappropriate to participate in this study by the principle investigator
4) Subjects with menstruation during the study period
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Miyazaki |
Organization
Center for Environment, Health and Field Sciences, Chiba University
Division name
Natural Therapy Laboratory
Zip code
277-0882
Address
6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
TEL
04-7137-8113
ymiyazaki@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Miyazaki |
Organization
Center for Environment, Health and Field Sciences, Chiba University
Division name
Natural Therapy Laboratory
Zip code
277-0882
Address
6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
TEL
04-7137-8113
Homepage URL
http://www.fc.chiba-u.jp/research/miyazaki/index.html
ymiyazaki@faculty.chiba-u.jp
Sponsor or person
Institute
Center for Environment, Health and Field Sciences, Chiba University
Institute
Department
Personal name
Funding Source
Organization
Tokyo wood cooperatives
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Forestry and Forest Products Research Institute
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of the Center for Environment, Health and Field Sciences, Chiba University
Address
6-2-1 Kashiwa-no-ha, Kashiwa, Chiba 277-0882, Japan
Tel
04-7137-8010
field-rinri@chiba-u.jp
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
| 2018 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
https://jwoodscience.springeropen.com/articles/10.1186/s10086-020-01876-1
Publication of results
Published
Result
URL related to results and publications
https://jwoodscience.springeropen.com/articles/10.1186/s10086-020-01876-1
Number of participants that the trial has enrolled
27
Results
The results found that the uzukuri wood significantly decreased oxy-Hb concentration in the left prefrontal cortex compared with touching the marble. Compared to before contact, the uzukuri wood showed significantly decreased oxy-Hb concentrations in the right prefrontal cortex, increased ln(HF), and decreased the ln(LF/HF) ratio. The contact with sanded wood significantly decreased oxy-Hb concentrations in the right prefrontal cortex compared with before contact.
Results date posted
| 2020 | Year | 06 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Female university students
Participant flow
Key exclusion criteria
1) Subjects who are in a poor physical condition
2) Subjects who have a respiratory illness
3) Subjects deemed inappropriate to participate in this study by the principle investigator
4) Subjects with menstruation during the study period
Adverse events
None
Outcome measures
1) Prefrontal activity using near-infrared spectroscopy
2) Sympathetic and parasympathetic nervous system activity as indicated by heart rate variability
3) Heart rate
4) Profile of Mood State
5) Modified semantic differential method
6) Kwansei Gakuin (KG) daily life questionnaire
7) Trait Anxiety of State-Trait Anxiety Inventory
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 17 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 10 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 10 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 31 | Day |
Last modified on
| 2020 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037425
