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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044408
Receipt No. 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 2021/06/02

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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
Email 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
Email r-yano@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2021 Year 06 Month 02 Day
Date of IRB
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
2021 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050728

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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