UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029316
Receipt number R000033512
Scientific Title The effect of self-administered skincare routines using cosmetics on elderly residents' mental health and activities of daily living: a six-month control trial in nursing homes
Date of disclosure of the study information 2017/09/28
Last modified on 2022/10/04 12:43:36

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Basic information

Public title

The effect of self-administered skincare routines using cosmetics on elderly residents' mental health and activities of daily living: a six-month control trial in nursing homes

Acronym

A six-month control trial of elderly residents' self-administered skincare routines in nursing home

Scientific Title

The effect of self-administered skincare routines using cosmetics on elderly residents' mental health and activities of daily living: a six-month control trial in nursing homes

Scientific Title:Acronym

A six-month control trial of elderly residents' self-administered skincare routines in nursing home

Region

Japan


Condition

Condition

Adult

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of facial skin care on self-body image, self-esteem, well-being, depressive symptoms and social cognitive function of aging residents.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The Cutaneous Body Image Scale

Key secondary outcomes

The Rosenberg Self-Esteem Scale
Philadelphia Geriatric Center Morale Scale
Geriatric Depression Scale
Cognitive items of the Functional Independence Measure


Base

Study type

Interventional


Study design

Basic design

Parallel

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

Behavior,custom Other

Interventions/Control_1

Three month of skincare routine

Interventions/Control_2

Non three month of skincare routine

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

105 years-old >=

Gender

Female

Key inclusion criteria

To be able to make self-administered skincare routines using the cosmetics

Key exclusion criteria

Notto be able to make self-administered skincare routines using the cosmetics

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masumi Nagae

Organization

Graduate School of Kyushu University of Aguriculture

Division name

Department of AgroEnvironmental Sciences Laboratory of systematic Forest and Forest Products Science

Zip code


Address

Collabo-station 2-711 3-1-1 Maidashi Higashi-ku Fukuoka

TEL

092-642-6527

Email

nagae.masumi.258@m.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masumi Nagae

Organization

Graduate School of Kyushu University of Aguriculture

Division name

Department of AgroEnvironmental Sciences Laboratory of systematic Forest and Forest Products Science

Zip code


Address

Collabo-station 2-711 3-1-1 Maidashi Higashi-ku Fukuoka

TEL

092-642-6527

Homepage URL


Email

nagae.masumi.258@m.kyushu-u.ac.jp


Sponsor or person

Institute

Graduate School of Kyushu University of Aguriculture
Department of Agro-Environmental Sciences Laboratory of systematic Forest and Forest Products Science

Institute

Department

Personal name



Funding Source

Organization

MEXT/JSPS KAKENHI

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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 09 Month 28 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

2017 Year 04 Month 01 Day

Date of IRB

2017 Year 08 Month 08 Day

Anticipated trial start date

2017 Year 09 Month 28 Day

Last follow-up date

2019 Year 02 Month 09 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 09 Month 27 Day

Last modified on

2022 Year 10 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033512


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name