UMIN-CTR Clinical Trial

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