UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051810 |
|---|---|
| Receipt number | R000059108 |
| Scientific Title | Effects of Variation in Bed Height during Hygienic Assistance on the Contractions of the Erector Spinae Muscles among Caregivers: A Quasi-Experimental Study |
| Date of disclosure of the study information | 2023/08/03 |
| Last modified on | 2024/02/02 09:43:16 |
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Basic information
Public title
Effects of Variation in Bed Height during Hygienic Assistance on Lumbar Load among Caregivers: A Quasi Experimental Study
Acronym
Effects of Variation in Bed Height during Hygienic Assistance on Lumbar Load among Caregivers: A Quasi-Experimental Study
Scientific Title
Effects of Variation in Bed Height during Hygienic Assistance on the Contractions of the Erector Spinae Muscles among Caregivers: A Quasi-Experimental Study
Scientific Title:Acronym
Effects of Variation in Bed Height during Hygienic Assistance on the Contractions of the Erector Spinae Muscles among Caregivers: A Quasi-Experimental Study
Region
| Japan |
Condition
Condition
low back pain
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of different bed heights during the implementation of hygiene care on the caregiver's forward leaning posture, the erector spinae muscles and pain are clarified using objective and subjective indicators, and suggestions are made regarding the appropriate bed height for the prevention of low back pain.
Basic objectives2
Others
Basic objectives -Others
Suggestions are made regarding the appropriate bed height for the prevention of low back pain.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electromyogram of erector spinae muscles during hygiene care when bed height is set at 35%, 40%, and 45% of height in three groups
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Ask participants to perform hygiene care with 35% bed height as the condition setting.
Interventions/Control_2
Ask participants to perform hygiene care with 40% bed height as the condition setting.
Interventions/Control_3
Ask participants to perform hygiene care with 45% bed height as the condition setting.
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
| 19 | years-old | <= |
Age-upper limit
| 21 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
2nd-4th year students of this department who understand the purpose of this study and have given consent to participate in the study
who have had experience in hygine care in class
Key exclusion criteria
People with a history of chronic back pain
Pregnant or suspected pregnancy
Menstruating women with back pain
People who are over 175 cm in height
People who have complaints of poor physical condition.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | KEIICHI |
| Middle name | |
| Last name | URANAKA |
Organization
Tokyo Healthcare University
Division name
Higashigaoka Faculty of Nursing
Zip code
1528558
Address
2-5-1 Higashigaoka Meguro Tokyo, Japan
TEL
+81357795031
k-uranaka@thcu.ac.jp
Public contact
Name of contact person
| 1st name | KEIICHI |
| Middle name | |
| Last name | URANAKA |
Organization
Tokyo Healthcare University
Division name
Higashigaoka Faculty of Nursing
Zip code
1528558
Address
2-5-1 Higashigaoka Meguro Tokyo, Japan
TEL
+81357795031
Homepage URL
k-uranaka@thcu.ac.jp
Sponsor or person
Institute
Tokyo Healthcare University
Institute
Department
Personal name
KEIICHI URANAKA
Funding Source
Organization
Tokyo Healthcare University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethical Review Board for Human-related Research, Tokyo Healthcare University
Address
4-1-17 Higasshigotanda Shinagawa Tokyo, Japan
Tel
+81354217655
rinri@thcu.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
東京医療保健大学東が丘看護学部
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 03 | 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
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 25 | 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 | 08 | Month | 03 | Day |
Last modified on
| 2024 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059108
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
