UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051936 |
|---|---|
| Receipt number | R000059267 |
| Scientific Title | Examination of facial pillows used for prone positioning after a vitreous surgery -Crossover study in healthy subjects- |
| Date of disclosure of the study information | 2023/08/18 |
| Last modified on | 2024/03/22 14:42:09 |
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Basic information
Public title
Comparative study of facial pillows used for prone positioning after a vitreous surgery
Acronym
Comparative study of facial pillows used for prone positioning after a vitreous surgery
Scientific Title
Examination of facial pillows used for prone positioning after a vitreous surgery
-Crossover study in healthy subjects-
Scientific Title:Acronym
Crossover study of facial pillows used for prone positioning after a vitreous surgery
Region
| Japan |
Condition
Condition
macular hole, rhegmatogenous retinal detachment
Classification by specialty
| Ophthalmology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the shape and material of a facial pillow suitable for reducing distress in the prone position during vitreoretinal surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Face pressure
Key secondary outcomes
Facial redness, face temperature, muscle hardness, environmental temperature and humidity around the face, subjective distress
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The U-shaped urethane face pillow
Interventions/Control_2
The U-shaped beads face pillow
Interventions/Control_3
The U-shaped natural rubber face 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
Male and Female
Key inclusion criteria
Healthy students aged 18 to 39.
Key exclusion criteria
Subjects with difficulty maintaining the prone position due to eye disease, low 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
951-8518
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
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 18 | 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
The forehead interface pressure of the urethane pillow was the highest of the three types of pillows. The environmental temperature around the face with the urethane pillow significantly rosed than the rubber pillow after 30 minutes in the prone position. The environmental humidity around the face decreased significantly after 30 minutes in prone position using bead pillows and rubber pillows. The score for forehead pain when using the urethane pillow was significantly higher than the bead pillow.
Results date posted
| 2024 | Year | 03 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were 21 participants in their 20s (5 males and 16 females).
Participant flow
Experiments were performed using the following steps.
1) A subject change into the uniform.
2) Measure body temperature
3) Take a photo of subject's face.
4) Measure their face temperature
5) Subject lies down in prone position
6) Measure facial pressure distribution for 3 minutes
7) Measure interface pressure in the forehead and both cheeks
8) Measure muscle hardness
9) Start lying down in prone position and measuring the environmental temperature and humidity around the face for 30 minutes.
(10) Measure interface pressure in the forehead and both cheeks.
(11) Measure muscle hardness.
(12) Measure face temperature in a sitting position.
(13) Take a photo of subject's face.
(14) Measure body temperature.
(15) Evaluates subjective distress and interview the feeling of using the pillows.
In the same way, each subject conducts the experiment for 3 times (washout interval of 1 day).
The order of intervention for each pillow is randomly assigned by drawing lots.
Adverse events
Nothing.
Outcome measures
1) facial pressure distribution
2) the environmental temperature and humidity around the face
3) face temperature
4) facial skin
5) subjective distress
6) muscle hardness
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 10 | Month | 20 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059267
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