UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041417
Receipt number R000047259
Scientific Title Reliability and validity of facial check sheet (FCS): Checklist for self-satisfaction with cosmetic acupuncture
Date of disclosure of the study information 2020/08/15
Last modified on 2020/09/04 13:23:39

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Basic information

Public title

Reliability and validity of facial check sheet (FCS): Checklist for self-satisfaction with cosmetic acupuncture

Acronym

Reliability and validity of facial check sheet (FCS)

Scientific Title

Reliability and validity of facial check sheet (FCS): Checklist for self-satisfaction with cosmetic acupuncture

Scientific Title:Acronym

Reliability and validity of facial check sheet (FCS)

Region

Japan


Condition

Condition

Adult women

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study examined the reliability and validity of facial check sheet(FCS) that can be used in cosmetic acupuncture.

Basic objectives2

Others

Basic objectives -Others

We examined the reliability and validity of facial check sheet (FCS).

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The contents of the survey were age, sex, skin disease status, face care status, face concern status, and facial check sheet(FCS) items created by us.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Female

Key inclusion criteria

It is a Japanese woman living in Japan.

Key exclusion criteria

The study were age, those who did not fill in the survey items, and men.

Target sample size

142


Research contact person

Name of lead principal investigator

1st name Hidetoshi
Middle name
Last name Mori

Organization

National University Corporation Tsukuba University of Technology

Division name

Department of Health, Faculty of Health Science

Zip code

350-8521

Address

4-12-7 Kasuga, Tsukuba City, Ibaraki Prefecture, 305-8521, Japan

TEL

+81-29-856-3570

Email

h.mori.tsukuba@gmail.com


Public contact

Name of contact person

1st name Hiroshi
Middle name
Last name Kuge

Organization

Osaka Medical College Hospital

Division name

Department of Anesthesiology Pain Clinic

Zip code

569-8686

Address

2-7 Daigaku-machi, Takatsuki City, Osaka Prefecture, 569-8686, Japan

TEL

+81-90-1487-1151

Homepage URL


Email

sherry@kha.biglobe.ne.jp


Sponsor or person

Institute

National University Corporation Tsukuba University of Technology

Institute

Department

Personal name



Funding Source

Organization

National University Corporation Tsukuba University of Technology

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

Osaka Medical College Hospital

Address

2-7 Daigaku-machi, Takatsuki City, Osaka Prefecture, 569-8686, Japan

Tel

+81-90-1487-1151

Email

sherry@kha.biglobe.ne.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

2020 Year 08 Month 15 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-bin/fileshare/registrant.cgi

Publication of results

Unpublished


Result

URL related to results and publications

https://upload.umin.ac.jp/cgi-bin/fileshare/registrant.cgi

Number of participants that the trial has enrolled

142

Results

The facial check sheet (FCS) showed reliability between FCS items, and showed validity between the condition of the facial region and FCS items.

Results date posted

2020 Year 08 Month 14 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

We have created a facial check sheet (FCS).
And, the evaluation judgment was performed using FCS at the time of cosmetic acupuncture operation. However, the FCS is collateral for a few cases of credibility analysis and has not investigated its validity.

Participant flow

The number of people used for outcome analysis and the number of people used for statistical analysis were the same as those at the start of the study.

Adverse events

There were no unintended effects (adverse events).

Outcome measures

The contents of the survey were age, sex, skin disease status, face care status, face concern status, and facial check sheet(FCS) items created by us.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 05 Month 01 Day

Date of IRB

2017 Year 06 Month 22 Day

Anticipated trial start date

2017 Year 07 Month 01 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Cross-sectional research by internet survey


Management information

Registered date

2020 Year 08 Month 14 Day

Last modified on

2020 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047259


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name