UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058795 |
|---|---|
| Receipt number | R000067229 |
| Scientific Title | Preventive Acupuncture Using Multi-Core Thumbtack Needles at PC6 (Neiguan) for Virtual Reality Sickness: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/08/20 |
| Last modified on | 2025/08/13 15:41:32 |
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Basic information
Public title
Preventive Acupuncture Using Multi-Core Thumbtack Needles at PC6 (Neiguan) for VR Sickness
Acronym
Preventive Acupuncture Using Multi-Core Thumbtack Needles at PC6 (Neiguan) for VR Sickness
Scientific Title
Preventive Acupuncture Using Multi-Core Thumbtack Needles at PC6 (Neiguan) for Virtual Reality Sickness: A Randomized Controlled Trial
Scientific Title:Acronym
Preventive Acupuncture Using Multi-Core Thumbtack Needles at PC6 (Neiguan) for Virtual Reality Sickness: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Virtual Reality Sickness
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of preventive acupuncture therapy using multi-core thumbtack needles at PC6 (Neiguan) as a symptomatic treatment for virtual reality (VR) sickness, a condition that currently lacks a fundamental solution.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numeric Rating Scale (NRS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Control Group: Received a sham (placebo) needle
Interventions/Control_2
Intervention Group: Received a multi-core thumbtack needle
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male
Key inclusion criteria
Individuals who have experienced, or have a history of, VR sickness or motion sickness.
Key exclusion criteria
Individuals with underlying medical conditions (particularly Meniere's disease or vestibular migraine).
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Shogo |
| Middle name | |
| Last name | Miyazaki |
Organization
Teikyo Heisei University
Division name
Faculty of Health Care
Zip code
1708445
Address
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo
TEL
03-5843-3111
s.miyazaki@thu.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Miyazaki |
Organization
Teikyo Heisei University
Division name
Faculty of Health Care
Zip code
1708445
Address
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo
TEL
03-5843-3111
Homepage URL
s.miyazaki@thu.ac.jp
Sponsor or person
Institute
Teikyo Heisei University
Institute
Department
Personal name
Funding Source
Organization
LINTEC Corporation
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
Teikyo Heisei University
Address
2-51-4 Higashiikebukuro, Toshima-ku, Tokyo
Tel
03-5843-3111
rec@thu.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
| 2025 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 08 | Month | 13 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067229
