UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055059 |
|---|---|
| Receipt number | R000062899 |
| Scientific Title | The Effects of Hand-Mediated Vibration on the Human Body: A Randomized Crossover Study |
| Date of disclosure of the study information | 2024/07/24 |
| Last modified on | 2024/07/25 08:36:02 |
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Basic information
Public title
Study on the Effects of Hand-Mediated Micro-Vibration Nursing Care on the Human Body
Acronym
Hand-Mediated Micro-Vibration Nursing Care Study
Scientific Title
The Effects of Hand-Mediated Vibration on the Human Body: A Randomized Crossover Study
Scientific Title:Acronym
Hand-Mediated Micro-Vibration Effect Study
Region
| Japan |
Condition
Condition
Not applicable (study targets healthy individuals)
Classification by specialty
| Nursing | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of manual micro-vibration nursing care on the human body.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessment of autonomic function using heart rate variability analysis
Key secondary outcomes
Changes in skin conductance
Changes in breathing patterns
Evaluation of pleasant/unpleasant and active/inactive feelings using Visual Analog Scale
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Duration: Each intervention period is 1 day
Dose: Frequency of micro-vibration generated by the device is 7-9 Hz, amplitude 3-5 mm
Frequency and frequency: Each site is treated for 30 seconds, total of 6 sites, 3-4 minutes in total
Details: The intervention subjects lie in the prone position, and the device is applied to 6 sites: trapezius muscle and lower edge of scapula, central part of trapezius muscle and scapula, point pressed down from the central part of the clavicle to the trapezius muscle, both shoulder joints and deltoid muscles, both greater trochanters, and around the lumbar vertebrae 4-5. The device is attached to the hand and used to compare with and without vibration.
Interventions/Control_2
Duration: Each intervention period is 1 day
Dose: No use of vibration generator device
Frequency and frequency: Each site is treated for 30 seconds, total of 6 sites, 3-4 minutes in total
Details: The intervention subjects lie in the prone position, and the device is not applied to the 6 sites: trapezius muscle and lower edge of scapula, central part of trapezius muscle and scapula, point pressed down from the central part of the clavicle to the trapezius muscle, both shoulder joints and deltoid muscles, both greater trochanters, and around the lumbar vertebrae 4-5. The comparison is made between no vibration and intervention with vibration.
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. Age between 18 and 60 years old
2. Able to provide informed consent
Key exclusion criteria
1. Individuals with evident arrhythmia
2. Individuals taking oral medication affecting hemodynamics
3. Individuals who smoke or consume excessive alcohol
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Teppei |
| Middle name | |
| Last name | Yamashita |
Organization
Kansai University of Social Welfare
Division name
Department of Nursing
Zip code
678-0255
Address
380-3, Shinden, Ako-shi, Hyogo, Japan
TEL
+81-791-46-2525
t-yamashita2024@umin.ac.jp
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Yamashita |
Organization
Kansai University of Social Welfare
Division name
Department of Nursing
Zip code
678-0255
Address
380-3, Shinden, Ako-shi, Hyogo, Japan
TEL
+81-791-46-2525
Homepage URL
t-yamashita2024@umin.ac.jp
Sponsor or person
Institute
Kansai University of Social Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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 Okayama Prefectural University
Address
111 Kuboki, Soja-shi, Okayama, Japan
Tel
+81-866-94-2111
t-yamashita2024@umin.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
| 2024 | Year | 07 | Month | 24 | 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
| 2024 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 24 | Day |
Last modified on
| 2024 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062899
| Research Plan | |
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| Registered date | File name |
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