UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039373 |
|---|---|
| Receipt number | R000044896 |
| Scientific Title | Verification of the face pillows for patients maintaining a prone position after vitrectomy to distribute pressure and relieve distress. |
| Date of disclosure of the study information | 2020/02/03 |
| Last modified on | 2021/02/16 17:21:37 |
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Basic information
Public title
Verification of the face pillows for patients maintaining a prone position after vitrectomy to distribute pressure and relieve distress.
Acronym
Verification of the face pillow for patients maintaining a prone position after vitrectomy
Scientific Title
Verification of the face pillows for patients maintaining a prone position after vitrectomy to distribute pressure and relieve distress.
Scientific Title:Acronym
Verification of the face pillow for patients maintaining a prone position after vitrectomy
Region
| Japan |
Condition
Condition
Retinal detachment,Macular hole
Classification by specialty
| Ophthalmology | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to verify materials of the face pillows for healthy women maintaining a prone position to distribute pressure and relieve distress.This examination will contribute the patients maintaining a prone position after vitrectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Interface pressure
(2) Muscle fatigue level
(3) Subjective distress (NRS)
Key secondary outcomes
(1)Skin condition
(2)Posture collapse
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The 3 types of face pillows use by healthy women who maintained prone position on a microbead cushion for 60 minutes each. Each intervention is on a different day.
Type A is a box-shaped urethane pillow hollowed out in a half cycle shape(This is used in A hospital).
Interventions/Control_2
Type B is a U-shaped microbead pillow.
Interventions/Control_3
Type C is a U-shaped soft urethane pillow.
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
Healthy female students in A university
Key exclusion criteria
Ohthalmic diseases
Backache
Stiff shoulder
Poor physical condition
Difficult to maintain prone position
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomoe |
| Middle name | |
| Last name | Yokono |
Organization
Niigata University
Division name
Medical and Dental Science
Zip code
9518518
Address
2-746 Asahimachi-dori, Chuo-ku, NIIGATA
TEL
0252270940
tyokono@clg.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoe |
| Middle name | |
| Last name | Yokono |
Organization
Niigata University
Division name
Medical and Dental Science
Zip code
9518518
Address
2-746 Asahimachi-dori, Chuo-ku, Niigata
TEL
0252270940
Homepage URL
tyokono@clg.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University Ethics Review Committee
Address
757-1 Asahimachi-dori, Chuo-ku, Niigata
Tel
0252272625
ethics@adm.niigata-u.ac.jp
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
| 2020 | Year | 02 | Month | 03 | 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
20
Results
The interface pressure of the U shaped pillows were lower than the follow box shaped pillow. On the other hand, U shaped pillows might be difficult to breathe and U shaped microbead pillow might have blockage or oppression. Hence, the confort pillow should be keep wide contact area and good air permeability.
Results date posted
| 2021 | Year | 02 | Month | 16 | Day |
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
| 2019 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 03 | Day |
Last modified on
| 2021 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044896
