UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052961 |
|---|---|
| Receipt number | R000060103 |
| Scientific Title | Verification of Psychophysiological Effects Induced by Head Massage Therapy. |
| Date of disclosure of the study information | 2024/11/30 |
| Last modified on | 2023/12/01 10:24:20 |
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Basic information
Public title
Verification of Psychophysiological Effects Induced by Head Massage Therapy.
Acronym
Verification of Psychophysiological Effects Induced by Head Massage Therapy.
Scientific Title
Verification of Psychophysiological Effects Induced by Head Massage Therapy.
Scientific Title:Acronym
Verification of Psychophysiological Effects Induced by Head Massage Therapy.
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the psychophysiological effects on the mind and body of manual massage applied to the head and neck region.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The autonomic nervous system (Pupil measurement (pupillary light reflex), Vascular age assessment.)
Key secondary outcomes
The central nervous system (brain age assessment, flicker measurement, postural sway assessment)
Psychological questionnaires (SCL30, VAS, Multiple measurements of emotion using a multiple mood scale (40 questions))
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Perform a 15-minute massage on the head (including the face and the top of the head).
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy males and females aged 30 to 59 years old when informed consent.
2. Subjects who can give informed consent to partake in this research, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects who are in the habit of smoking.
2. Subjects who are receiving medication due to treatment of disease at the time of consent.
3. Subjects who have taken or applied medication for the treatment of any diseases. within the past month (excluding the common cold, but including treatment for hay fever).
4. Subjects who have undergone surgery in the area to be treated (including neck, face, and crown of the head) within the past six months.
5. Subjects currently participating in another clinical trial or those who have participated in a clinical trial within the past month.
6. Subjects who have previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood.
7. Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
8. Subjects who have symptom of dermatologic disease such as atopic dermatitis.
9. Others who have been determined ineligible by investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Niwa |
Organization
Share Co.Ltd
Division name
Representative of Director
Zip code
136-0063
Address
2107 Galleria Grande, 1-2-11 Ariake, Koto-ku, Tokyo, Japan
TEL
03-5530-4445
share28.co@gmail.com
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Niwa |
Organization
Share Co.Ltd
Division name
Representative of Director
Zip code
136-0063
Address
2107 Galleria Grande, 1-2-11 Ariake, Koto-ku, Tokyo, Japan
TEL
03-5530-4445
Homepage URL
share28.co@gmail.com
Sponsor or person
Institute
Share Co.Ltd
Institute
Department
Personal name
Funding Source
Organization
Share Co.Ltd
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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
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
| 2024 | Year | 11 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 30 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060103
