UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019859 |
|---|---|
| Receipt number | R000022943 |
| Scientific Title | Study of effective cosmetic therapy program for the elderly |
| Date of disclosure of the study information | 2015/11/19 |
| Last modified on | 2016/06/14 13:27:17 |
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Basic information
Public title
Study of effective cosmetic therapy program for the elderly
Acronym
Study of effective cosmetic therapy program
Scientific Title
Study of effective cosmetic therapy program for the elderly
Scientific Title:Acronym
Study of effective cosmetic therapy program
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To discuss the effectiveness of the cosmetic therapy program for mind and body relaxation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The salivary amylase monitor measurements , two-dimensional mood scale , self-esteem scale, self-consciousness scale before and after cosmetic therapy program experience
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
1)individual practice plam:Experience of Cosmetic therapy ( including skin care )
Once implemented
Interventions/Control_2
2)Group practice plan:
Group psychology education program
( The discussion of appearance appeal of their own )
1.makeup before the practice once ( experimental group )
2.implementation once after cosmetic ( all , as a debriefing)
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Physically unimpaired elderly person
Key exclusion criteria
1) Person with skin disease
2) Person with a physical disability
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Saeko Ito |
Organization
Toyohashi Sozo University
Division name
Faculty of Health Nursing
Zip code
Address
20-1,Matusita,Usikawa-cho,Toyohashi, Aichi,Japan
TEL
050-2017-2256
s-ito@sozo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Saeko Ito |
Organization
Toyohashi Sozo University
Division name
Faculty of Health Nursing
Zip code
Address
20-1,Matusita,Usikawa-cho,Toyohashi, Aichi,Japan
TEL
050-2017-2256
Homepage URL
s-ito@sozo.ac.jp
Sponsor or person
Institute
Saeko Ito
Institute
Department
Personal name
Funding Source
Organization
Toyohashi Sozo University
Toyohashi-sity
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
Address
Tel
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
豊橋創造大学
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 19 | 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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 10 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 10 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 08 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 19 | Day |
Last modified on
| 2016 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022943
| 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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