UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039317
Receipt No. R000044845
Scientific Title A verification test of psychological and physiological effects of head massage treatment.
Date of disclosure of the study information 2020/08/31
Last modified on 2020/10/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A verification test of psychological and physiological effects of head massage treatment.
Acronym A verification test of psychological and physiological effects of head massage treatment.
Scientific Title A verification test of psychological and physiological effects of head massage treatment.
Scientific Title:Acronym A verification test of psychological and physiological effects of head massage treatment.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify psychological and physiological effects bring by head massage treatment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes *Evaluation of autonomic nervous system, by iris measurement and skin temperature measurement
* Evaluation of parasympathetic nervous system, by measurement for function of field of view and stabilometry
*Flicker test
Key secondary outcomes * Evaluation of autonomic nervous system, by measurement of acceleration pulse wave of peripheral artery
* Vas questionnaire
* Multiple mood scale short version

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Resting more than 10min-measurements and questionnaires- head massage treatment- measurements and questionnaires- resting- measurements and questionnaires
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

Not applicable
Gender Female
Key inclusion criteria 1. Female aged more than 20 years when informed consent.
2. Subjects who show understanding of the clinical study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria 1. Subjects who have smoking habit.
2. Subjects who are cold-sensitive constitution. (including subjects like that who feel cold on their hands and foots even in summer)
3. Subjects who are receiving medication due to treatment of disease.
4. In a past month, subjects who have had custom of taking or applying medicine for the treatment of diseases. (Except for cold but include for pollen allergy.)
5. Subjects who have previous and/or current medical history of serious disease in liver, kidney, heart, lung and/or blood.
6. Pregnant or expected pregnant, or lactating women.
7. Subjects who have symptom of dermatologic disease such as atopic dermatitis.
8. Subjects who feel pain in their knee, or subjects who feel pain or discomfort when bent their knee.
9. Subjects who have undergone surgery on investigation objective portion within the past 6 months.
10. Subjects who are participating the other clinical tests. Subjects who participated within a month prior to the current study and/or who plan to participate the other clinical tests.
11. Other who is determined ineligible by investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hiromi
Middle name
Last name Niwa
Organization Share Company Ltd.
Division name President
Zip code 135-0063
Address 2107 Galleria Grande, 1-2-11, Ariake, Koto-ku, Tokyo 135-0063, Japan
TEL 090-2324-7550
Email info@cpcc.co.jp

Public contact
Name of contact person
1st name Yukihiro
Middle name
Last name Yada
Organization University of Tsukuba, School of Integrative
Division name Global Majors
Zip code 305-8577
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577 Japan
TEL 029-853-7344
Homepage URL
Email yada.yukihiro.gb@u.tsukuba.ac.jp

Sponsor
Institute Share Company Ltd.
Institute
Department

Funding Source
Organization Share Company Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Institutional Review Board of Chiyoda Paramedical Care Clinic
Address 2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel 03-5297-5548
Email IRB@cpcc.co.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

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 31 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 20
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
2019 Year 08 Month 16 Day
Date of IRB
2019 Year 08 Month 16 Day
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
2020 Year 01 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
2020 Year 01 Month 30 Day
Last modified on
2020 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044845

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.