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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031639
Receipt No. R000036127
Scientific Title A study of physiological and psychological change by touching non-woven
Date of disclosure of the study information 2018/03/08
Last modified on 2018/05/15

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Basic information
Public title A study of physiological and psychological change by touching non-woven
Acronym Physiological and psychological change by touching non-woven
Scientific Title A study of physiological and psychological change by touching non-woven
Scientific Title:Acronym Physiological and psychological change by touching non-woven
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the physiological and psychological change by touching non-woven
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement and assessment of salivary hormones and psychological states before and after touching three kinds of non-woven
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Touching non-woven A->Touching non-woven C->Touching non-woven B->No touching
Interventions/Control_2 Touching non-woven B->No touching->Touching non-woven C->Touching non-woven A
Interventions/Control_3 Touching non-woven C->Touching non-woven A->No touching->Touching non-woven B
Interventions/Control_4 No touching->Touching non-woven B->Touching non-woven A->Touching non-woven C
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
59 years-old >=
Gender Female
Key inclusion criteria -Healthy females
-Subjects with using and experience of diapers
-Subjects without breastfeeding
Key exclusion criteria -Subjects with systemic illness
-Subjects with a skin disease, and are consulting with the dermatologist
-Subjects with a severe rough hand
-Subjects with a disease in the oral cavity, and are consulting with the medical institution
-The pregnant and subjects who hope to get pregnant during the exam period
-Subjects who are taking prescription medicine
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoko Saito
Organization Kao Corporation
Division name Kansei Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7683
Email saito.nao@kao.com

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Sakamoto
Organization Kao Corporation
Division name Kansei Science Research
Zip code
Address 2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7682
Homepage URL
Email sakamoto.takashi@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
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
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 花王株式会社(栃木県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

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
2018 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 08 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
2018 Year 03 Month 08 Day
Last modified on
2018 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036127

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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