UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021622 |
|---|---|
| Receipt number | R000024718 |
| Scientific Title | Examination of the comfortable same posture retention time to judge it from vital reaction |
| Date of disclosure of the study information | 2016/03/27 |
| Last modified on | 2017/03/30 10:32:50 |
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Basic information
Public title
Examination of the comfortable same posture retention time to judge it from vital reaction
Acronym
Examination of the comfortable same posture retention time
Scientific Title
Examination of the comfortable same posture retention time to judge it from vital reaction
Scientific Title:Acronym
Examination of the comfortable same posture retention time
Region
| Japan |
Condition
Condition
The person who has difficulty in changing position by oneself
Classification by specialty
| Medicine in general | Surgery in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
You investigate vital reaction to result from the same posture, a subjective response in a viewpoint of the comfort, and determine the changing position interval in the viewpoint of the comfort by determining possibility time of the same posture maintenance
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The 2-hour same posture maintenance.
Vital signs
Key secondary outcomes
Alpha-amylase activity in saliv.
STAI
profile of mood states second edition
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
| Maneuver |
Interventions/Control_1
We have you spend 15-30 minutes with locus or decubitus freely and describe stress-resistant degree check list (following STCL), STAI, POMS in the meantime.We conduct body pressure, temperature, blood pressure, heart rate, a respiratory rate, ptyalin measurement after the course for 15-30 minutes and do the maintenance of the same posture with initiation.We measure blood pressure, heart rate, a respiratory rate every 15 minutes. Temperature, the ptyalin measurement are carried out every 30 minutes.We assume the maintenance of the same posture the end in up to 120 minutes, but we have you spend it with decubitus after the end freely for 30 minutes and perform final measurements at 30 minutes and do it with the experiment end.
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
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Five healthy men without the underlying disease of age 20-30 generations, ten people of five women in total.
It is less than 25 more than BMI18.5.
Key exclusion criteria
There is underlying disease.
We use pain-killer regularly.
More than less than BMI18.5, 25.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hayato Sumi |
Organization
Masters degree course in Asahikawa Medical University Graduate School medicine system graduate course
Division name
Basic nursing
Zip code
Address
1-1-1, Midorigaokahigashi-2-jo, Asahikawa-shi, Hokkaido
TEL
0166693570
sumi-88@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hayato Sumi |
Organization
Masters degree course in Asahikawa Medical University Graduate School medicine system graduate cours
Division name
Basic nursing
Zip code
Address
1-1-1, Midorigaokahigashi-2-jo, Asahikawa-shi, Hokkaido
TEL
0166693570
Homepage URL
sumi-88@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University Graduate School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 03 | Month | 27 | 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
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
| 2015 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 26 | Day |
Last modified on
| 2017 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024718
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
