UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059390 |
|---|---|
| Receipt number | R000067925 |
| Scientific Title | Effects of Differences in Body Part Heights on Pressure Distribution in the Prone Position |
| Date of disclosure of the study information | 2025/10/14 |
| Last modified on | 2025/10/14 14:01:48 |
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Basic information
Public title
Effects of Differences in Body Part Heights on Pressure Distribution in the Prone Position
Acronym
Effects of Differences in Body Part Heights on Pressure Distribution in the Prone Position
Scientific Title
Effects of Differences in Body Part Heights on Pressure Distribution in the Prone Position
Scientific Title:Acronym
Effects of Differences in Body Part Heights on Pressure Distribution in the Prone Position
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate how changes in the height of posture-supporting devices, such as face-down pillows and chest supports, influence body pressure distribution and subjective discomfort in the prone position.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body pressure distribution (mean body pressure and contact area)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Prone-position support pads for the head, chest, and abdomen (baseline height condition)
Interventions/Control_2
Prone-position support pads (head elevated only)
Interventions/Control_3
Prone-position support pads (head and chest elevated)
Interventions/Control_4
Prone-position support pads (chest elevated only)
Interventions/Control_5
Prone-position support pads (chest and abdomen elevated)
Interventions/Control_6
Prone-position support pads (abdomen elevated only)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals aged between 18 and 60 years who are in good health and able to understand the Japanese language.
Individuals who can provide written informed consent to participate in the study of their own free will.
Individuals in good physical condition who are capable of maintaining the prone position independently.
Key exclusion criteria
Individuals with physical pain or movement restrictions.
Individuals who experience pain when assuming the positions required for the experiment.
Individuals with a body mass index (BMI) of less than 18.5 or greater than 30.
Individuals with a height of less than 150 cm or greater than 180 cm.
Individuals who are pregnant or may be pregnant.
Individuals with diseases or conditions that may cause sudden changes in health status.
Individuals deemed inappropriate for participation in this experiment by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Hamanishi |
Organization
Kansai University og Social Welfare
Division name
Nursing Faculty
Zip code
678-0255
Address
380-3 Shinden, Ako-shi, Hyogo, Japan
TEL
09097380252
sj.eyes76@gmail.com
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Hamanishi |
Organization
Kansai University of Social Welfare
Division name
Faculty of Nursing
Zip code
7000914
Address
380-3 Shinden, Ako, Hyogo
TEL
0791462545
Homepage URL
hamanishi@kusw.ac.jp
Sponsor or person
Institute
Kansai University of Social Welfare
Institute
Department
Personal name
Funding Source
Organization
Internal research grant from Kansai University of Social Welfare
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
Ethical review board of Kansai University of Social Welfare
Address
380-3 Shinden, Ako, Hyogo
Tel
0791-46-2545
kusw-kango@kusw.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
| 2025 | Year | 10 | Month | 14 | 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
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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 14 | Day |
Last modified on
| 2025 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067925
