UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039384
Receipt number R000044885
Scientific Title Psychological effects of microbubble bathing
Date of disclosure of the study information 2020/02/06
Last modified on 2021/02/04 09:29:54

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Basic information

Public title

Psychological effects of microbubble bathing

Acronym

Psychological effects of microbubble bathing

Scientific Title

Psychological effects of microbubble bathing

Scientific Title:Acronym

Psychological effects of microbubble bathing

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluate psychological effects and muscle hardness of bathing in a micro bubble bath.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relaxing effect

Key secondary outcomes

Muscle tension


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

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Tap water bathing,
single time
Micro bubble bathing,
single time

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy adults: bathing is not prohibited by doctors.

Key exclusion criteria

Poor physical condition

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Masao
Middle name
Last name Nonoyama

Organization

Rinnai Corporation

Division name

R&D Headquarters

Zip code

480-0133

Address

3-1 Kaechi, Oguchi-cho,Niwa-gun, Aichi, Japan

TEL

0587-95-5702

Email

rsiken200214@gmail.com


Public contact

Name of contact person

1st name Masao
Middle name
Last name Nonoyama

Organization

Rinnai Corporation

Division name

R&D Headquarters

Zip code

480-0133

Address

3-1 Kaechi, Oguchi-cho,Niwa-gun, Aichi, Japan

TEL

0587-95-5702

Homepage URL


Email

rsiken200214@gmail.com


Sponsor or person

Institute

Rinnai Corporation

Institute

Department

Personal name



Funding Source

Organization

Rinnai Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Japan Health & Research Institute
Tokyo City University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Japan Health & Research Institute

Address

Garou Building 8F 3-1-4 Nihonbashi Cyuou-ku, Tokyo

Tel

03-5290-1621

Email

info@jph-ri.or.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 02 Month 06 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/jjhr/41/0/41_20200423/_article/-char/ja

Number of participants that the trial has enrolled

11

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

Main results already published

Date of protocol fixation

2020 Year 01 Month 31 Day

Date of IRB

2020 Year 01 Month 31 Day

Anticipated trial start date

2020 Year 02 Month 06 Day

Last follow-up date

2020 Year 04 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 02 Month 04 Day

Last modified on

2021 Year 02 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044885


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name