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
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
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
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
