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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039373
Receipt No. 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 2020/02/03

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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
Email 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
Email tyokono@clg.niigata-u.ac.jp

Sponsor
Institute Niigata University
Institute
Department

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
Email 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
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 No longer recruiting
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
2020 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044896

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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