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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042440
Receipt No. R000048449
Scientific Title Verification of head massage-inducing effects on brain waves and heart beat variability
Date of disclosure of the study information 2021/11/20
Last modified on 2021/05/21

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Basic information
Public title Verification of head massage-inducing effects on brain waves and heart beat variability
Acronym Verification of head massage-inducing effects on brain waves and heart beat variability
Scientific Title Verification of head massage-inducing effects on brain waves and heart beat variability
Scientific Title:Acronym Verification of head massage-inducing effects on brain waves and heart beat variability
Region
Japan

Condition
Condition Healthy female adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to verify some kind of clinical effect on brain waves and heart rate variability by massage operation to the head
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Brain waves
2. Heart rate variability
Key secondary outcomes 1. Visual Analog Scale (VAS)-
questionnaire scores
2. Oxytocin in saliva

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
Maneuver
Interventions/Control_1 Giving a massage to the subject's head for 20 min, including neck/facial/parietal operations.
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Female
Key inclusion criteria (1) Healthy female subjects ranging in age from 20 to 64.
(2) Subjects who can give informed consent to participate in this research after being provided with an explanation of the protocol detail.
Key exclusion criteria (1) Subjects falling into the habit of smoking.
(2) Subjects with some kind of continuous medical treatment, at the moment of giving informed consent to participate in this research.
(3) Subjects who have undergone some kind of medical treatment/application within the last month into this research (except taking in some cold remedies, but curing pollinosis).
(4) Subjects having present/previous medical history of serious diseases in liver, kidney, heart, lung, and/or blood.
(5) Pregnant, possibly pregnant, or lactating women.
(6) Subjects with some kind of skin symptom, disease or disorder, just like atopic dermatitis.
(7) Subjects having experience of some kind of skin-related trouble, because of putting a surgical tape on their facial part and/or region of chest.
(8) Subjects who have undergone some kind of surgical treatment for their head, including neck/facial/parietal operations, within six months into this trial.
(9) Subjects who are now under the other clinical trials with some kind of medicine/food, or have participated in similar tests within a month after those.
(10) Others who have been determined as ineligible for participation, judging from the investigator's opinions.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hiromi
Middle name
Last name Niwa
Organization Share Company
Division name President
Zip code 135-0063
Address 1-2-11-2107 Ariake, Koto-ku, Tokyo 135-0063, Japan
TEL 090-2334-7550
Email share28.co@gmail.com

Public contact
Name of contact person
1st name Masanori
Middle name
Last name Numa
Organization CPCC Company Limited
Division name Planning & Sales Department
Zip code 101-0047
Address 4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL 03-5297-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

Funding Source
Organization Share Company
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Graduate School of Integrative and Global Majors, Tsukuba University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of Chiyoda Paramedical Care Clinic
Address 2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel 03-5297-5548
Email IRB@cpcc.co.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
2021 Year 11 Month 20 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
2020 Year 10 Month 19 Day
Date of IRB
2020 Year 10 Month 16 Day
Anticipated trial start date
2020 Year 11 Month 20 Day
Last follow-up date
2020 Year 11 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 13 Day
Last modified on
2021 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048449

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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