UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058169 |
|---|---|
| Receipt number | R000066492 |
| Scientific Title | Subjective Evaluation and Physiological Response of Adult Participants in the Same Body Position for Different Head of Bed Elevation Angles |
| Date of disclosure of the study information | 2025/07/28 |
| Last modified on | 2025/06/13 14:58:02 |
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Basic information
Public title
A study on how bed angle affects perceived discomfort and physical responses
Acronym
Bed Angle and Body Response Study
Scientific Title
Subjective Evaluation and Physiological Response of Adult Participants in the Same Body Position for Different Head of Bed Elevation Angles
Scientific Title:Acronym
Response Evaluation Study on Different Head-of-Bed Elevation Angles
Region
| Japan |
Condition
Condition
Not Applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to identify the head-of-bed elevation angle that causes the least discomfort in adults maintaining the same body position, using subjective evaluation and physiological response as indicators.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Every 15 minutes from the start of measurement, participants will subjectively report the symptoms, affected body areas, and severity of discomfort caused by being unable to move.
Key secondary outcomes
Every 15 minutes from the start of measurement, vital signs including body temperature, pulse rate, blood pressure, respiratory rate, and oxygen saturation will be recorded.
Additionally, pressure measurements will be taken at the scapular, sacral, ischial, posterior thigh, and heel regions, and the total and average pressure values will be calculated.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Experiment 1 (Head-of-Bed Elevation at 30 degrees)
Interventions/Control_2
Experiment 2 (Head-of-Bed Elevation at 45 degrees)
Interventions/Control_3
Experiment 3 (Head-of-Bed Elevation at 60 degrees)
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
| 45 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Participants will be men and women aged between 45 and under 65 years.
2.Participants must be able to take part in all three experiments: Experiment 1 (head-of-bed elevation at 30 degrees), Experiment 2 (head-of-bed elevation at 45 degrees), and Experiment 3 (head-of-bed elevation at 60 degrees).
Key exclusion criteria
1.Individuals with diseases that may cause dizziness or malaise due to elevation or lowering of the head or foot sections of the bed.
2.Individuals without current or past history of lumbar spine disorders.
3.Individuals currently undergoing treatment for any disease.
4.Individuals without subjective symptoms of paralysis or pain, for the purpose of pain assessment.
5.Individuals who have taken analgesics within the past 24 hours.
6.Women who are menstruating.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Inokuchi |
Organization
Osaka Metropolitan University
Division name
Department of Nursing Science
Zip code
545-0051
Address
OOSAKAHUOOSAKASHIABENOKUASAHIMACHI
TEL
0666453511
sr24793v@st.omu.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Inokuchi |
Organization
Osaka Metropolitan University
Division name
Department of Nursing Science
Zip code
545-0051
Address
OOSAKAHUOOSAKASHIABENOKUASAHIMACHI
TEL
0666453511
Homepage URL
masamochi1107@icloud.com
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan 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
Osaka Metropolitan University
Address
OOSAKAHUOOSAKASHIABENOKUASAHIMACHI
Tel
0666453511
sr24793v@st.omu.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 | 07 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 06 | Month | 13 | Day |
Last modified on
| 2025 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066492
