UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059811 |
|---|---|
| Receipt number | R000068382 |
| Scientific Title | A Study on Facial Morphological Changes and Psychophysiological Responses to Acupoint Stimulation |
| Date of disclosure of the study information | 2025/11/18 |
| Last modified on | 2025/11/18 12:37:43 |
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Basic information
Public title
Research on Facial Morphological Changes and Psychophysiological Effects Induced by Acupoint Stimulation
Acronym
Research on Facial Morphological Changes and Psychophysiological Effects Induced by Acupoint Stimulation
Scientific Title
A Study on Facial Morphological Changes and Psychophysiological Responses to Acupoint Stimulation
Scientific Title:Acronym
On the Effects of Acupoint Stimulation on the Facial Region and the Mind Body System
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine facial morphological changes and psychophysiological effects induced by facial acupoint stimulation. Participants will receive facial acupressure, and 3D facial images will be taken before and after the intervention. Image analysis will be used to evaluate changes in facial morphology, and salivary amylase levels will be assessed. In addition, participants subjective responses, such as perceived relaxation, will also be evaluated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Facial morphological changes assessed by 3D image analysis
Objective measurements of facial shape differences before and after the intervention using the Vectra H2 system (e.g., changes in cheek volume, facial contour, and degree of lift).
2.Changes in salivary amylase levels
Evaluation of stress responses before and after the intervention, using salivary amylase as an index of autonomic nervous system activity.
Key secondary outcomes
1.Changes in subjective relaxation
Subjective evaluation using a questionnaire based on the shortened version of the Relaxation Rating Scale.
2.Subjective sensations after the intervention
Including mood, sense of lightness, overall comfort, and satisfaction.
3.Assessment of discomfort and safety during the intervention
Evaluation of any discomfort experienced and the presence or absence of adverse events.
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
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Acupressure will be applied to the facial acupoints Quanliao (SI18), Xiaguan (ST7), and Taiyang.
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
Male and Female
Key inclusion criteria
1) Healthy adults aged 20 to 65 years;
2) Individuals who have provided informed consent to participate in the study.
Key exclusion criteria
Individuals who do not meet the inclusion criteria
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | michiyo |
| Middle name | N/A |
| Last name | takano |
Organization
Niigata University of Health and Welfare
Division name
Department of Acupuncture, Moxibustion and Health
Zip code
950-3198
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
0252501918
michiyo-takano@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | michiyo |
| Middle name | N/A |
| Last name | takano |
Organization
Niigata University of Health and Welfare
Division name
Department of Acupuncture, Moxibustion and Health
Zip code
950
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
TEL
0252501918
Homepage URL
michiyo-takano@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
michiyo takano
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare Institutional Review Board
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
Tel
0252501918
michiyo-takano@nuhw.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
Niigata
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 18 | Day |
Last modified on
| 2025 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068382
