UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033939 |
|---|---|
| Receipt number | 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 | 2023/03/02 17:31:09 |
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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 | Yuriko |
| Middle name | |
| Last name | Ohkawa |
Organization
University of Miyazaki Faculty of Medicine
Division name
School of Nursing
Zip code
889-1692
Address
Miyazaki city kiyotake-chou-kihara 5200
TEL
0985-859816
yuriko_ookawa@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuriko |
| Middle name | |
| Last name | Ohkawa |
Organization
University of Miyazaki Faculty of Medicine
Division name
School of Nursing
Zip code
889-1692
Address
Miyazaki city kiyotake-chou-kihara 5200
TEL
0862357984
Homepage URL
yuriko_ookawa@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki Faculty of Medicine
Miyazaki city Kiyotake-chou-Kihara 5200
Institute
Department
Personal name
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
University of Miyazaki Hospital, Clinical Research Support Center
Address
Miyazaki city kiyotake-chou-kihara 5200
Tel
0985-85-9403
rinken@med.miyazaki-u.ac.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
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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 26 | Day |
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
| 2023 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038708
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
