UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058844 |
|---|---|
| Receipt number | R000067013 |
| Scientific Title | Verification of the effects of ear massage on people with sensitivity to cold |
| Date of disclosure of the study information | 2025/08/20 |
| Last modified on | 2025/08/19 21:56:11 |
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Basic information
Public title
Verification of the effects of ear massage on people with sensitivity to cold
Acronym
Verification of the effects of ear massage on people with sensitivity to cold
Scientific Title
Verification of the effects of ear massage on people with sensitivity to cold
Scientific Title:Acronym
Verification of the effects of ear massage on people with sensitivity to cold
Region
| Japan |
Condition
Condition
cold sensitivity
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.Clarify the characteristics of subjects who Cold Sensitivity.
2.Clarify the physiological and psychological effects of ear massage performed by the subjects themselves.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skin blood-flow volume, skin surface temperature, core temperature
Before intervention
Immediately after intervention
10 minutes after
20 minutes after
30 minutes after
Key secondary outcomes
blood pressure,pulse
observation with thirmography
Thermal sensation and comfort sensation by visual analogue scales
The Japanese Version of the Profile of Mood States
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
| Maneuver |
Interventions/Control_1
Self-ear massage for people with sensitivity to cold
Interventions/Control_2
Self-ear massage for people without sensitivity to cold (control 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Female with and without cold constitution
Key exclusion criteria
Smoker
Subjects with diseases under treatment
Subjects with heart disease or metabolic disease
Subjects with skin diseases or allergies
Pregnant women
Postmenopausal women
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Joboshi |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8906
hiroko-jo@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Joboshi |
Organization
Gunma University
Division name
Graduate School of Health Sciences
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma
TEL
027-220-8906
Homepage URL
hiroko-jo@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Hiroko Joboshi
Funding Source
Organization
Gunma University
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
Gunma University Medical Research Ethics Review Board for Human Subjects
Address
3- 3-39-15 Showa-machi, Maebashi, Gunma
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-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
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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | 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 | 19 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067013
