UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051487 |
|---|---|
| Receipt number | R000058741 |
| Scientific Title | Evaluating the effects of air cushions on body pressure distribution and thermal insulation in evacuation shelters |
| Date of disclosure of the study information | 2023/07/31 |
| Last modified on | 2026/03/25 18:27:07 |
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Basic information
Public title
Evaluating the effects of air cushions on body pressure distribution and thermal insulation in evacuation shelters
Acronym
Evaluating the effects of air cushions on body pressure distribution and thermal insulation in evacuation shelters
Scientific Title
Evaluating the effects of air cushions on body pressure distribution and thermal insulation in evacuation shelters
Scientific Title:Acronym
Evaluating the effects of air cushions on body pressure distribution and thermal insulation in evacuation shelters
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate whether air cushions could alleviate the concentrated body pressure and provide effective thermal insulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body pressure distribution (the body contact pressure, the body surface contour area)
Key secondary outcomes
NRS
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
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Sequence A: 1. Plastic sheets, 2. Blankets, 3. Urethane mats, 4. Air cushions
Interventions/Control_2
Sequence B: 1. Plastic sheets, 2. Blankets, 3. Air cushions, 4. Urethane mats
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. People who can give written informed consent (aged between 18 and 60 years).
2. People who can read and fill out explanatory documents, consent forms, and survey forms written in Japanese.
Key exclusion criteria
1. People suffering from musculoskeletal or neurogenic pain.
2. People with difficulty in supine and lateral positions for pain with positioning.
3. People who have a disease that may change suddenly.
4. BMI less than 16 and higher than 30
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Hamanishi |
Organization
Kansai University of Social Welfare
Division name
Faculty of Nursing/Graduate school of nursing
Zip code
6780255
Address
380-3 Shinden, Ako, Hyogo
TEL
0791462545
hamanishi@kusw.ac.jp
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/Graduate school of nursing
Zip code
6780255
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
Kansai University of Social Welfare
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
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
| 2023 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000058741
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/globalpublichealth/article?id=10.1371/journal.pgph.0005259
Number of participants that the trial has enrolled
20
Results
Compared with plastic sheets, air cushions reduced mean body pressure by more than 20% in both the supine and lateral positions and increased contact area by more than 30%. Compared with urethane pads, air cushions also showed significantly lower mean body pressure and significantly larger contact area. In subjective evaluations, air cushions were rated as less firm and more comfortable. Their thermal insulation was comparable to that of urethane pads.
Results date posted
| 2026 | Year | 03 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 20 participants were included, with 10 assigned to Sequence A and 10 to Sequence B. Overall, 19 participants (95.0%) were female and 1 was male. The mean age was 23.5 years and the mean BMI was 20.3. In Sequence A, there were 0 males and 10 females, with a mean age of 20.30 years and a mean BMI of 19.92. In Sequence B, there were 1 male and 9 females, with a mean age of 26.70 11.57 years and a mean BMI of 20.62.
Participant flow
Twenty participants were assessed for eligibility, and none were excluded, declined participation, or were lost to contact. All 20 participants were randomized, with 10 allocated to Sequence A and 10 to Sequence B. In Sequence A, participants received the interventions in the following order: period 1, plastic sheet; period 2, blanket; period 3, urethane pad; period 4, air cushion. In Sequence B, the order was: period 1, plastic sheet; period 2, blanket; period 3, air cushion; period 4, urethane pad. All 20 participants were included in the final analysis.
Adverse events
No adverse events reported.
Outcome measures
The primary outcome measures were body pressure distribution parameters, including mean body pressure and contact area. Secondary outcome measures included Numerical Rating Scale (NRS) assessments of comfort and perceived firmness, as well as thermal insulation assessed by surface temperature changes when each material was placed over a cooling gel pack. Body pressure distribution was measured in both the supine and lateral positions, and comparisons were made among air cushions, urethane pads, blankets, and plastic sheets.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 06 | Month | 30 | Day |
Last modified on
| 2026 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058741
