UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051899 |
|---|---|
| Receipt number | R000059219 |
| Scientific Title | Effect of a far-infrared heater that heats the feet with ceramic balls on autonomic nervous activity and mood states: crossover trial with footbath |
| Date of disclosure of the study information | 2023/08/14 |
| Last modified on | 2023/08/13 18:28:24 |
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Basic information
Public title
Effect of a far-infrared heater that heats the feet with ceramic balls on autonomic nervous activity and mood states: crossover trial with footbath
Acronym
Effect of a far-infrared heater that heats the feet with ceramic balls on autonomic nervous activity and mood states: crossover trial with footbath
Scientific Title
Effect of a far-infrared heater that heats the feet with ceramic balls on autonomic nervous activity and mood states: crossover trial with footbath
Scientific Title:Acronym
Effect of a far-infrared heater that heats the feet with ceramic balls on autonomic nervous activity and mood states: crossover trial with footbath
Region
| Japan |
Condition
Condition
Healthy women
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the relaxation effects of a far-infrared foot heating device using ceramic balls and a foot bath using hot water.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
low-frequency component (LF)/high-frequency
component (HF) during experiment
Key secondary outcomes
Profile of Mood States (POMS2) scores
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Using FIR foot heater that heats the feet with ceramic balls for 15 min
Interventions/Control_2
Footbath for 15 min
Interventions/Control_3
sitting for 15 min
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
| 21 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy adult females aged 21 to 22
Key exclusion criteria
cardiovascular medications, receiving outpatient care, with a sensory disorder or injury of the legs, with a pulmonary or neurological condition, or with a previous diagnosis of depression or on medications for depression or anxiety
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Matsui |
Organization
Komatsu University
Division name
Fuculty of Health Sciences, Department of Nursin
Zip code
9230961
Address
14-1 Mukaimotoorimachi, Komatsu, Ishikawa
TEL
0761483177
yuko.matsui@komatsu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Matsui |
Organization
Komatsu University
Division name
Fuculty of Health Sciences, Department of Nursing
Zip code
9230961
Address
14-1 Mukaimotoorimachi, Komatsu, Ishikawa
TEL
0761483177
Homepage URL
yuko.matsui@komatsu-u.ac.jp
Sponsor or person
Institute
Komatsu University
Institute
Department
Personal name
Funding Source
Organization
Yumeron Kurokawa Co
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Komatsu University
Address
14-1, Mukaimotorimachi, Komatsu, Ishikawa, Japan
Tel
0761483177
yuko.matsui@komatsu-u.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 | 08 | Month | 14 | Day |
Related information
URL releasing protocol
This study was performed as a crossover trial.
Publication of results
Unpublished
Result
URL related to results and publications
The FIR provides greater relaxing effects than a footbath
Number of participants that the trial has enrolled
27
Results
Changes in LF/HF were significantly lower in the FIR group than in the Footbath group after 15 min of intervention, and ccvHF was significantly higher after 5 min of intervention in the FIR group than in the Footbath group. The value 10 min after the end of intervention was significantly higher in the FIR group than in the Footbath group. The FIR group experienced reductions in the POMS2 dimensions of Fatigue-Inertia, Tension-Anxiety, and Total Mood Disturbance and an increase in Vigor-Activity.
Results date posted
| 2023 | Year | 08 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
7 women aged 21, 20 women aged 22.
Participant flow
Three participants dropped out.
Adverse events
None
Outcome measures
low-frequency component (LF)/high-frequency
component (HF) during experiment
Profile of Mood States (POMS2) scores
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | 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
| 2023 | Year | 08 | Month | 13 | Day |
Last modified on
| 2023 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059219
