UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040518 |
|---|---|
| Receipt number | R000045930 |
| Scientific Title | Effects of facial massages on cerebral activity |
| Date of disclosure of the study information | 2021/12/31 |
| Last modified on | 2025/04/15 11:34:18 |
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Basic information
Public title
Effects of facial massages on cerebral activity
Acronym
Effects of facial massages on cerebral activity
Scientific Title
Effects of facial massages on cerebral activity
Scientific Title:Acronym
Effects of facial massages on cerebral activity
Region
| Japan |
Condition
Condition
Healthy Person
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Massage is known to have various benefits, including relaxation and stress relief. Care by touching the skin such as massage therapy and touch therapy is introduced in medical settings to reduce patients' pain or tension. In this study, we will investigate the effect of massage on cerebral activity. The biological reactions when relaxed or after pleasant stimuli by massage will be examined by measuring protein amounts in saliva, and to examine the effect of massage on cerebral activity, MRI will be performed.
Basic objectives2
Others
Basic objectives -Others
Novel insights on cerebral activities responding to pleasant stimuli may be obtained: e.g., elucidation of activated neural pathway in the brain or mechanisms of mental function activation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary cortisol before and after facial massage will be measured, by which the physical and mental stress relief by massage will be evaluated.
Key secondary outcomes
The influence of facial massage on the body will be examined by performing fMRI and measuring heart rate and pulse rate before and after the massage.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
-Comprehension of purpose
-Free consent obtained
Key exclusion criteria
-History of severe head injury, severe depression, cerebral lesion or psychiatric disorder
-MRI-unsafe metal in the body or on the body surface
-Contraindication for MRI, such as during pregnancy
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Hasegawa |
Organization
Nagoya University Graduate school of medicine
Division name
Nagoya University-MENARD Collaborative Research Chair
Zip code
466-8550
Address
65 Tsrumai-cho, Showa-ku, Nagoya, 466-8550
TEL
052-744-2350
hasegawa.seiji.g9@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Hasebe |
Organization
Nagoya University Graduate school of medicine
Division name
Nagoya University-MENARD Collaborative Research Chair
Zip code
466-8550
Address
65 Tsrumai-cho, Showa-ku, Nagoya, 466-8550
TEL
052-744-2350
Homepage URL
hasebe.yuichi.e3@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University-MENARD Collaborative Research Chair Nagoya University Graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University-MENARD Collaborative Research Chair Nagoya University Graduate school of medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
NIPPON MENARD COSMETIC CO.,LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Nagoya University Graduate School of Medicine
Address
65 Tsrumai-cho, Showa-ku, Nagoya
Tel
052-744-2973
ethics@med.nagoya-u.ac.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
名古屋大学医学部医学系研究科
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 31 | 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
23
Results
Results of phychological evaluation after facial massage confirmed an increase in comfort and areduction in stress. Cortisol in saliva, an indicator of stress, was greatly reduced after facial massage. the results of fMRI data analysis confirmed that the brain connectivity was enhanced in specific brain regions after facial massage.
Results date posted
| 2024 | Year | 05 | Month | 29 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Testing delayed due to COVID-19 infestation.
Date of the first journal publication of results
| 2024 | Year | 05 | Month | 29 | Day |
Baseline Characteristics
23 healty female participants (mean age : 35 years)
Participant flow
Adverse events
.
Outcome measures
Cortisol concentration in saliva
Chromogranin A concentration in saliva
Oxytocin concentration in saliva
17beta estradiol concentration in saliva
Immuno globulin A concentration in saliva
Psychological evaluation tests
fMRI was performed using a 3TMRI system (Simens Verio)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2020 | Year | 05 | Month | 26 | Day |
Last modified on
| 2025 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045930
