UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033498 |
|---|---|
| Receipt number | 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 | 2019/07/25 11:47:25 |
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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
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
m15202045@gunma-u.ac.jp
Sponsor or person
Institute
Gunma university
Institute
Department
Personal name
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
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
35
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
| 2018 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 28 | 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 | 07 | Month | 24 | Day |
Last modified on
| 2019 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038200
| 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 |
