UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049485 |
|---|---|
| Receipt number | R000056347 |
| Scientific Title | Temperature changes in peripheral skin associated with autonomic nervous system activity |
| Date of disclosure of the study information | 2022/11/12 |
| Last modified on | 2023/11/24 18:33:41 |
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Basic information
Public title
Responding to stress, relaxation and changes in hand temperature
Acronym
Responding to stress, relaxation and changes in hand temperature
Scientific Title
Temperature changes in peripheral skin associated with autonomic nervous system activity
Scientific Title:Acronym
Temperature changes in peripheral skin associated with autonomic nervous system activity
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between the relaxed state and peripheral skin temperature.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Peripheral skin temperature during changes in autonomic nervous system activity.
Key secondary outcomes
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Stress load, Relaxation method
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
| 18 | years-old | <= |
Age-upper limit
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult men and women between the ages of 18 and 29.
Key exclusion criteria
Injuries to hands.
Feeling strong anxiety in closed spaces.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Sakai |
Organization
Niigata University
Division name
Graduate school of health sciences
Zip code
9518518
Address
746 Asahimachidori 2bancho, Chuo-ku, Niigata City, Niigata Prefecture
TEL
0252270941
sakai@clg.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayuri |
| Middle name | |
| Last name | Sakai |
Organization
Niigata University
Division name
Graduate school of health sciences
Zip code
9518518
Address
746 Asahimachidori 2bancho, Chuo-ku, Niigata City, Niigata Prefecture
TEL
0252270941
Homepage URL
sakai@clg.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Niigata 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
Ethics Committee of Niigata University
Address
757 Asahimachidori 1bancho, Chuo-ku, Niigata City, Niigata Prefecture
Tel
025-227-2625
ethics@adm.niigata-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
| 2022 | Year | 11 | Month | 12 | 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
8
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
| 2022 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 01 | 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
| 2022 | Year | 11 | Month | 12 | Day |
Last modified on
| 2023 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056347
