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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021622
Receipt No. 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

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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
Email 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
Email sumi-88@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University Graduate School
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024718

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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