UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the comfortable same posture retention time to judge it from vital reaction
Title of the study (Brief title)	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	Hayato Sumi
Organization	Masters degree course in Asahikawa Medical University Graduate School medicine system graduate course
Division name	Basic nursing
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	Hayato Sumi
Organization	Masters degree course in Asahikawa Medical University Graduate School medicine system graduate cours
Division name	Basic nursing
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000024718