UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057460 |
|---|---|
| Receipt number | R000063221 |
| Scientific Title | Comparative study of the air cell pillow and the rubber U-shaped pillow for distributing facial pressure and reducing physical pain in prone position after vitreoretinal surgery |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2025/03/31 14:45:21 |
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Basic information
Public title
Comparative study of the air cell pillow and the rubber U-shaped pillow for distributing facial pressure and reducing physical pain in prone position after vitreoretinal surgery
Acronym
Comparative study of face pillows in prone position after vitreoretinal surgery
Scientific Title
Comparative study of the air cell pillow and the rubber U-shaped pillow for distributing facial pressure and reducing physical pain in prone position after vitreoretinal surgery
Scientific Title:Acronym
Comparative study of face pillows in prone position after vitreoretinal surgery
Region
| Japan |
Condition
Condition
The purpose of this study is to compare the air cell pillow and the rubber U-shaped pillow for distributing facial pressure and reducing physical pain in prone position after vitreoretinal surgery.
Classification by specialty
| Ophthalmology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the air cell pillow and the rubber U-shaped pillow for distributing facial pressure and reducing physical pain in prone position after vitreoretinal surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Facial pressure distribution
Key secondary outcomes
Local facial pressure values
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
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
The air cell pillow
Interventions/Control_2
The rubber U-shaped pillow
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy college students over 18 years old
Key exclusion criteria
People who have difficulty lying down due to eye disease, back pain, stiff shoulders, poor physical condition, etc.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomoe |
| Middle name | |
| Last name | Yokono |
Organization
Niigata University Graduate School of Health Sciences
Division name
Department of Nursing
Zip code
9518518
Address
2-746 Asahimachi-dori, Chuo-ku, Niigata, 951-8518, Japan
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 Graduate School of Health Sciences
Division name
Department of Nursing
Zip code
951-8518
Address
2-746 Asahimachi-dori, Chuo-ku, Niigata, 951-8518, Japan
TEL
0252270940
Homepage URL
tyokono@clg.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Tomoe Yokono
Funding Source
Organization
Niigata University
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
Ethics Committee of Niigata University
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata, 951-8510, Japan
Tel
025-227-2005
joho@med.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
新潟大学医学部保健学科
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 31 | 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
21
Results
For the maximum facial pressure site, the air cell pillow had the most cases of pressure on the chin (16 cases). For the rubber U-shaped pillow, there were 6 cases of the forehead, and 6 cases of the left cheek. When comparing the local facial pressure values between the face pillows, the facial pressure of the air cell pillow was less significant than that of the rubber U-shaped pillow for both the forehead and cheeks.
Results date posted
| 2025 | Year | 03 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were 21 subjects (7 males, 14 females), with the mean (standard deviation) age of 25.0 (5.87) years. The mean (standard deviation) face size was 20.6 (0.79) cm long and 14.7 (0.72) cm wide. The mean (standard deviation) body mass index was 20.8 (2.97) kg/m2.
Participant flow
Adverse events
None
Outcome measures
Facial pressure distribution, local facial pressure values
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 08 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 31 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063221
