UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of effective cosmetic therapy program for the elderly
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Saeko Ito
Organization	Toyohashi Sozo University
Division name	Faculty of Health Nursing
Address	20-1,Matusita,Usikawa-cho,Toyohashi, Aichi,Japan
TEL	050-2017-2256
Email	s-ito@sozo.ac.jp

Public contact
Name of contact person	Saeko Ito
Organization	Toyohashi Sozo University
Division name	Faculty of Health Nursing
Address	20-1,Matusita,Usikawa-cho,Toyohashi, Aichi,Japan
TEL	050-2017-2256
Homepage URL
Email	s-ito@sozo.ac.jp

Sponsor
Institute	Saeko Ito
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022943