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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033498
Receipt No. R000038200
Scientific Title Effects of scalp massage on physiological and psychological responses during shampooing
Date of disclosure of the study information 2018/08/27
Last modified on 2018/07/24

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Basic information
Public title Effects of scalp massage on physiological
and psychological responses during shampooing
Acronym Effects of scalp massage on physiological
and psychological responses during shampooing
Scientific Title Effects of scalp massage on physiological
and psychological responses during shampooing
Scientific Title:Acronym Effects of scalp massage on physiological
and psychological responses during shampooing
Region
Japan

Condition
Condition The target condition is healthy adults.
It is expected to apply to hospitalized patients who have stress or feel anxiety about surgery or diseases.
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is clarified how the shampoo method that the scalp massage is added affects the physiological and psychological reaction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clear feeling (psychological refreshing feeling)
Key secondary outcomes Skin blood flow rate, heart rate variability, blood pressure, relaxation feeling, refreshing feeling (physical refreshing feeling)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Shampoo with scalp massage
Interventions/Control_2 Shampoo only
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
28 years-old >=
Gender Female
Key inclusion criteria A healthy woman over 20 years old and under 28 years old
Key exclusion criteria The person whose hair length is under the shoulder more than 20 cm
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Natsuko Yanagi
Organization Gunma university
Division name Graduate school of health science
Zip code
Address 3-39-22,Showa-machi Maebashi, Gunma
TEL 027-220-7111
Email natsuy@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yui Takahashi
Organization Gunma university
Division name School of health science
Zip code
Address 3-39-22,Showa-machi Maebashi, Gunma
TEL 027-220-7111
Homepage URL
Email m15202045@gunma-u.ac.jp

Sponsor
Institute Gunma university
Institute
Department

Funding Source
Organization Gunma university
Organization
Division
Category of Funding Organization Other
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
2018 Year 08 Month 27 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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 27 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 07 Month 24 Day
Last modified on
2018 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038200

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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