UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042440 |
|---|---|
| Receipt number | 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 12:15:57 |
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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
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
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048449
