UMIN-CTR Clinical Trial

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