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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000033939
Receipt No. R000038708
Scientific Title Study of physiological and psychological responses to facial massage and its application as a nursing skill
Date of disclosure of the study information 2018/08/29
Last modified on 2019/02/28

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Basic information
Public title Study of physiological and psychological responses to facial massage and its application as a nursing skill
Acronym Study of physiological and psychological responses to facial massage
Scientific Title Study of physiological and psychological responses to facial massage and its application as a nursing skill
Scientific Title:Acronym Study of physiological and psychological responses to facial massage
Region
Japan

Condition
Condition Stress-related fatigue
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this research was to determine the physiological and psychological responses to facial massage.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We evaluated the effectiveness of face massage wuth vital signs,salivary amylase, prefrontal blood flow,POMS,VAS.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 facemassage(3min.)-wash out(1week)-rest(3min)
Interventions/Control_2 rest(3min.)-wash out(1week)- face massage (3min)
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
25 years-old >=
Gender Female
Key inclusion criteria Age is over 20 years old
healthy woman
Subjects can judge themselves to participate in research
Key exclusion criteria Person with skin redness or eczema
Person who has a history of skin diseases such as atopic dermatitis Person who received massage in the past, who had a change in physical condition
Person who smoke
Pregnant women
Person who reacted in jojoba oil patch test
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuriko Ohkawa
Organization University of Miyazaki Faculty of Medicine
Division name School of Nursing
Zip code
Address Miyazaki city kiyotake-chou-kihara 5200
TEL 0985-859816
Email yuriko_ookawa@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuriko Ohkawa
Organization University of Miyazaki Faculty of Medicine
Division name School of Nursing
Zip code
Address Miyazaki city kiyotake-chou-kihara 5200
TEL 0862357984
Homepage URL
Email yuriko_ookawa@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki Faculty of Medicine
Miyazaki city Kiyotake-chou-Kihara 5200
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
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 宮崎大学医学部看護学科

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 29 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 Suspended
Date of protocol fixation
2015 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 29 Day
Last modified on
2019 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038708

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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