UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033666 |
|---|---|
| Receipt number | 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 | 2022/08/10 11:03:25 |
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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
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
uchiyama@clg.niigata-u.ac.jp
Sponsor or person
Institute
Graduate School of Health Sciences, Niigata University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 07 | Day |
Last modified on
| 2022 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038381
