UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039317
Receipt number 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 12:04:32

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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 or person

Institute

Share Company Ltd.

Institute

Department

Personal name



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

Value
https://center6.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