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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000045619
Receipt No. R000052083
Scientific Title A verification test of the effects on labor productivity of daytime rest habits using hot fomentation on eyes
Date of disclosure of the study information 2021/10/05
Last modified on 2021/10/05

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Basic information
Public title Efficacy test of daytime rest habits
Acronym Efficacy test of daytime rest habits
Scientific Title A verification test of the effects on labor productivity of daytime rest habits using hot fomentation on eyes
Scientific Title:Acronym Efficacy test of daytime rest habits
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Ophthalmology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the ophthalmologic efficacy and effects of labor productivity of hot fomentation on eyes for healthy subjects
Basic objectives2 Others
Basic objectives -Others Changes of QOL and working time by hot fomentation on eyes for healthy subjects
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Evaluation of the changes of ophthalmologic complaint, labor productivity, QOL, and working time after repeated treatment for 1week or 1week and 1month with hot fomentation on eyes.
Key secondary outcomes -Analysis of the degree of eye complaint or improvement, personality, community site participation status, and the habitation of daytime rest
-Changes in stress level and presentism in 2021 and 2022

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Apply the hot fomentation on eyes for 10 minutes once a day in the daytime. During the first week, the interventions are conducted for five consecutive days on weekdays. For the following month, the interventions are conducted at the time of preference, up to once a day.
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
65 years-old >=
Gender Male and Female
Key inclusion criteria Healthy males and females
Key exclusion criteria -Subjects with diseases, inflammation, wounds, swelling, eczema, etc. around eyes
-Subjects who are conscious of being sensitive to warmth
-Subjects who are aware of the decrease in warm sensation
-Subjects who are not good at menthol stimulation
-Subjects have difficulty to treat hot fomentation on eyes in the daytime
-Pregnancies and lactations
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Kyouko
Middle name
Last name Tagami
Organization Kao Corporation
Division name Personal Health Care Products Research Laboratory
Zip code 131-8501
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL +81-3-5630-7271
Email tagami.kyouko@kao.com

Public contact
Name of contact person
1st name Junko
Middle name
Last name Kitano
Organization Kao Corporation
Division name Personal Health Care Products Research Laboratory
Zip code 131-8501
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL +81-3-5630-7271
Homepage URL
Email kitano.junko@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Human Research Ethics Committee, Kao Corporation
Address 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel +81-3-5630-7263
Email morisaki.naoko@kao.com

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 花王株式会社(東京都)

Other administrative information
Date of disclosure of the study information
2021 Year 10 Month 05 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 Open public recruiting
Date of protocol fixation
2021 Year 09 Month 22 Day
Date of IRB
2021 Year 10 Month 05 Day
Anticipated trial start date
2021 Year 10 Month 05 Day
Last follow-up date
2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 09 Month 30 Day
Last modified on
2021 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052083

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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