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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033666
Receipt No. R000038381
Scientific Title Comparative study of comfortable positioning in prone position after retinal vitreous surgery
Date of disclosure of the study information 2018/09/01
Last modified on 2018/08/07

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Basic information
Public title Comparative study of comfortable positioning in prone position after retinal vitreous surgery
Acronym Comparative study of comfortable positioning in prone position after retinal vitreous surgery
Scientific Title Comparative study of comfortable positioning in prone position after retinal vitreous surgery
Scientific Title:Acronym Comparative study of comfortable positioning in prone position after retinal vitreous surgery
Region
Japan

Condition
Condition Retinal vitreous disease
Classification by specialty
Ophthalmology Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Quantitative verification of positioning after retinal vitreous surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of indicators of current and improved positioning
Body pressure, degree of muscle tone, Numerical Rating Scale, interview survey
Key secondary outcomes

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
Other
Interventions/Control_1 Current type and improved use items and positioning
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
50 years-old >=
Gender Male and Female
Key inclusion criteria Those that can hold a prone position for 2 hours (120 minutes) or more
Key exclusion criteria Shoulder pain, those with chronic diseases such as low back pain, sleep disorders, cardiovascular diseases, nervous system diseases, psychiatric diseases, urological diseases
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mieko Uchiyama
Organization Niigata University
Division name Graduate School of Health Sciences
Zip code
Address 2-746 Asahimachoi-dori, chiuo-ku, Niigata 951-8518 Japan
TEL 025-227-2263
Email uchiyama@clg.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mieko Uchiyama
Organization Niigata University
Division name Graduate School of Health Sciences
Zip code
Address Asahimachoi-dori, chiuo-ku, Niigata 951-8518 Japan
TEL 025-227-2263
Homepage URL
Email uchiyama@clg.niigata-u.ac.jp

Sponsor
Institute Graduate School of Health Sciences, Niigata University
Institute
Department

Funding Source
Organization Personal procurement
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
2018 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
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 Open public recruiting
Date of protocol fixation
2018 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 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
2018 Year 08 Month 07 Day
Last modified on
2018 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038381

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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