UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030483 |
|---|---|
| Receipt number | R000034805 |
| Scientific Title | Verification of effect of tactile massage by physiological index |
| Date of disclosure of the study information | 2017/12/20 |
| Last modified on | 2019/12/24 10:22:35 |
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Basic information
Public title
Verification of effect of tactile massage by physiological index
Acronym
Verification of effect of tactile massage
Scientific Title
Verification of effect of tactile massage by physiological index
Scientific Title:Acronym
Verification of effect of tactile massage
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the effect of tactile massage by physiological index for healthy adult women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary oxytocin
Key secondary outcomes
Salivary cortisol
Heart rate variability frequency range analyzer
State-Trait Anxiety Inventory From JYZ(STAI-JYZ)
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
| Maneuver |
Interventions/Control_1
Receive tactile massage for 20 minutes
Interventions/Control_2
Keep resting position for 20 minutes
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
A healthy person
Key exclusion criteria
People who are being treated with hand skin diseases, arrhythmias, autonomic diseases, and oral diseases.
People who are allergic to olive oil.
Pregnant.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshiko |
| Middle name | |
| Last name | Uehara |
Organization
University of Fukui
Division name
Division of Nursing, Faculty of Medical
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki Eiheiji Yoshida Fukui
TEL
0776-61-8291
uehara@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiko |
| Middle name | |
| Last name | Uehara |
Organization
University of Fukui
Division name
Division of Nursing, Faculty of Medical
Zip code
910-1193
Address
23-3 Matsuokashimoaizuki Eiheiji Yoshida Fukui
TEL
0776-61-8291
Homepage URL
uehara@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
University of Fukui
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
University of Fukui
Address
23-3 Matsuokashimoaizuki Eiheiji Yoshida Fukui
Tel
0776-61-8291
uehara@u-fukui.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
| 2017 | Year | 12 | 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
20
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
| 2017 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2018 | 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
| 2017 | Year | 12 | Month | 20 | Day |
Last modified on
| 2019 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034805
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
