UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044408 |
|---|---|
| Receipt number | R000050728 |
| Scientific Title | Changes in Autonomic Nervous Activity and Skin Surface Temperature with Time for Hot Compress to the Lumbar Region (Maruyama Method) |
| Date of disclosure of the study information | 2021/06/02 |
| Last modified on | 2023/06/12 12:58:52 |
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Basic information
Public title
Changes in Autonomic Nervous Activity and Skin Surface Temperature with Time for Hot Compress to the Lumbar Region (Maruyama Method)
Acronym
Changes in Autonomic Nervous Activity and Skin Surface Temperature with Time for Hot Compress to the Lumbar Region (Maruyama Method)
Scientific Title
Changes in Autonomic Nervous Activity and Skin Surface Temperature with Time for Hot Compress to the Lumbar Region (Maruyama Method)
Scientific Title:Acronym
Changes in Autonomic Nervous Activity and Skin Surface Temperature with Time for Hot Compress to the Lumbar Region (Maruyama Method)
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify changes in autonomic nervous activity and skin surface temperature with time for hot compress to the lumbar region (Maruyama Method)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Autonomic nervous activity (Heart rate variability)
skin surface temperature
Vital signs (Blood pressure, Heart rate, temperature)
Subjective evaluation of hot compress
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
No treatment
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
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Hot compress to the lumbar region for 30 minutes
Interventions/Control_2
Hot compress to the lumbar region for 20 minutes
Interventions/Control_3
Rest for 30 minutes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The age is older than 20 years of age.
The person that a document agreed by the free was provided after enough understanding after having received enough explanation on participating to this study.
Key exclusion criteria
Those who have no skin diseases or skin abnormalities.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Rika |
| Middle name | |
| Last name | Yano |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Department of Fundamental Nursing
Zip code
0600812
Address
Nishi-5 Kita-12 Jo, Kita-ku, Sapporo, Hokkaido 060-0812, Japan
TEL
011-706-3323
r-yano@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Rika |
| Middle name | |
| Last name | Yano |
Organization
Faculty of Health Sciences, Hokkaido University
Division name
Department of Fundamental Nursing
Zip code
0600812
Address
Nishi-5 Kita-12 Jo, Kita-ku, Sapporo, Hokkaido, Japan
TEL
011-706-3323
Homepage URL
r-yano@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido 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
Faculty of Health Sciences, Hokkaido University
Address
Nishi-5 Kita-12 Jo, Kita-ku, Sapporo, Hokkaido, Japan
Tel
011-706-3323
r-yano@med.hokudai.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
北海道大学大学院保健科学研究院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 02 | 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
| 2021 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | 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
| 2021 | Year | 06 | Month | 02 | Day |
Last modified on
| 2023 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050728
