UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037565
Receipt number R000042818
Scientific Title The evaluation of stress responses using cardboard bed
Date of disclosure of the study information 2019/09/01
Last modified on 2020/03/05 15:57:18

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Basic information

Public title

The evaluation of stress responses using cardboard bed

Acronym

The evaluation of stress responses using cardboard bed

Scientific Title

The evaluation of stress responses using cardboard bed

Scientific Title:Acronym

The evaluation of stress responses using cardboard bed

Region

Japan


Condition

Condition

Healthy adult males

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the stress responses when lying on the floor and the cardboard bed, and to evaluate the usefulness of the cardboard bed.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Heart rate variability
salivary amylase activity

Key secondary outcomes

subjective emotions


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking

YES

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Lying on the cardboard bed for sixty minutes.

Interventions/Control_2

Lying on the floor for sixty minutes.

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

18 years-old <=

Age-upper limit

29 years-old >=

Gender

Male

Key inclusion criteria

1.Students or participants in the disaster volunteer study group.
2.These who voluntarily submit written informed consent.

Key exclusion criteria

1.Subjects taking drug.
2.Subjects with arrhythmia.
3.Subjects with low back pain.
4.Subjects with abnormality in the oral cavity.

Target sample size

12


Research contact person

Name of lead principal investigator

1st name Masae
Middle name
Last name Amiki

Organization

Yamaguchi University

Division name

Division of Fundamental Nursing, Faculty of Health Sciences,School of Medicine

Zip code

755-8505

Address

1-1-1 Minami-kogushi,Ube,Yamaguchi

TEL

0836-22-2822

Email

amiki@yamaguchi-u.ac.jp


Public contact

Name of contact person

1st name Masae
Middle name
Last name Amiki

Organization

Yamaguchi University

Division name

Division of Fundamental Nursing, Faculty of Health Sciences,School of Medicine

Zip code

755-8505

Address

1-1-1 Minami-kogushi,Ube,Yamaguchi

TEL

0836-22-2822

Homepage URL


Email

amiki@yamaguchi-u.ac.jp


Sponsor or person

Institute

Division of Fundamental Nursing, Faculty of Health Sciences,School of Medicine,Yamaguchi University

Institute

Department

Personal name



Funding Source

Organization

Yamaguchi University

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Review Board School of Health Sciences

Address

1-1-1 Minami-kogushi,Ube,Yamaguchi

Tel

0836-22-2007

Email

me202@yamaguchi-u.ac.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

山口大学大学院医学系研究科(山口県)


Other administrative information

Date of disclosure of the study information

2019 Year 09 Month 01 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

12

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 07 Month 01 Day

Date of IRB

2019 Year 08 Month 30 Day

Anticipated trial start date

2019 Year 09 Month 09 Day

Last follow-up date

2019 Year 09 Month 19 Day

Date of closure to data entry

2019 Year 09 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 08 Month 01 Day

Last modified on

2020 Year 03 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042818


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name