UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052640 |
|---|---|
| Receipt number | R000060060 |
| Scientific Title | Quantification of Shape Changes in the Facial Region by Auricular Stimulation and Their Psychosomatic Effects |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2025/02/07 09:17:18 |
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Basic information
Public title
Quantification of Shape Changes in the Facial Region by Auricular Stimulation and Their Psychosomatic Effects
Acronym
Objectification of facial changes due to ear acupuncture stimulation and its effects on the body and mind
Scientific Title
Quantification of Shape Changes in the Facial Region by Auricular Stimulation and Their Psychosomatic Effects
Scientific Title:Acronym
Quantification of Shape Changes in the Facial Region by Auricular Stimulation and Their Psychosomatic Effects
Region
| Japan |
Condition
Condition
Healthy adult female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have reported subjective shape changes in the facial region induced by pressure stimulation of the auricle (granular acupuncture stimulation). However, no study has objectively quantified the shape change. Therefore, the purpose of this study is to quantitatively quantify the shape change of the facial region induced by auricular stimulation using a three-dimensional imaging device. In addition, we will examine the autonomic nervous system responses that may be related to the shape change of the face by using heart rate and stress scales to explore the effects on the mind and body.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3D image analysis device (VECTRA Handy H2: pre- and post-treatment measurements by Canfield Scientific): weekly intervention test for 4 weeks, weekly no stimulation test, total of 8 measurements.
Key secondary outcomes
Subjective changes before and after treatment (pre- and post-treatment changes in facial area points, questionnaire; name, gender, age, height, weight, date and time, before and after treatment and progress, identification of adverse events)
Autonomic nervous system variability measurement: measurement with HPO-200T3 (pulse rate, %SpO2)
Stress Scale (PHRF-SCL(SF): Stress Checklist Short Form)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
In the intervention (granular acupuncture), granular acupuncture needles are applied to acupuncture points on the auricular (Shenmen and eye). The needles were applied for 5 days, removed on the 5th day, and continued for 2 more days, for a total of 7 days, for 4 weeks.
In the no stimulation group, no stimulation is performed and only measurement and evaluation are performed as in the intervention group.
Interventions/Control_2
In the no stimulation group, no stimulation is performed and only measurement and evaluation are performed as in the intervention group.
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy adults between the ages of 20 and 50
Those who are aware of sagging of the facial area.
Those who have given their consent to participate in the study.
Key exclusion criteria
Those who receive acupuncture to the face on a regular basis.
Those who are allergic to titanium, the material used to make acupuncture needles.
Those who have craniofacial diseases or dental treatments that may cause geometrical changes in the facial area.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Michiyo |
| Middle name | |
| 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
025-250-1918
michiyo-takano@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Michiyo |
| Middle name | |
| 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
025-250-1918
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398 Shimamicho, Kita-ku, Niigata City, Niigata Prefecture
Tel
025-250-1918
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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 01 | 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
15
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
| 2023 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2023 | Year | 10 | Month | 27 | Day |
Last modified on
| 2025 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060060
