UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056912 |
|---|---|
| Receipt number | R000065044 |
| Scientific Title | Evaluation of the relaxation effect of foot bathing in healthy young women -Effects on autonomic nervous activity and emotional state- |
| Date of disclosure of the study information | 2025/02/03 |
| Last modified on | 2026/02/05 14:45:12 |
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Basic information
Public title
Evaluation of the relaxation effect of foot bathing in healthy young women
-Effects on autonomic nervous activity and emotional state-
Acronym
Evaluation of the relaxation effect of foot bathing in young women
Scientific Title
Evaluation of the relaxation effect of foot bathing in healthy young women
-Effects on autonomic nervous activity and emotional state-
Scientific Title:Acronym
Evaluation of the relaxation effect of foot bathing in young women
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to conduct foot bathing for healthy young women and to verify the relaxing effect based on autonomic nervous activity and subjective evaluation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
autonomic nervous activity
Key secondary outcomes
Short version of the Multifaceted Emotional State Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In a room with the appropriate environment, participants are asked to fill out a questionnaire (short version of the Multifaceted Emotion Scale). A wireless electrocardiogram (GMC Mem Calc/Banally Light) is attached to measure autonomic nerve activity, and measurement with the electrocardiogram begins. The participants are asked to remain at rest in a seated position for 5 minutes. After that, they are given a foot bath (water temperature 40C) for 15 minutes. After the foot bath, the researcher wipes the moisture off the participants' feet. The participants are asked to remain at rest in a seated position for 5 minutes, after which measurement with the electrocardiogram is stopped and the electrocardiogram is removed. After that, participants are asked to fill out a questionnaire (short version of the Multifaceted Emotion Scale).
Interventions/Control_2
In a room with the appropriate environment, participants are asked to fill out a questionnaire (short version of the Multifaceted Emotion Scale). A wireless electrocardiogram (GMC Mem Calc/Banally Light) is attached to measure autonomic nerve activity, and measurement with the electrocardiogram begins. The participants are asked to remain at rest in a seated position for 25 minutes, and when the time has elapsed, measurement with the electrocardiogram is stopped and the electrocardiogram is removed. After that, participants are asked to fill out a questionnaire (short version of the Multifaceted Emotion Scale).
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
| 19 | years-old | <= |
Age-upper limit
| 34 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Understand the purpose of the study and agree to participate in the study
2.Able to read and write Japanese
Key exclusion criteria
1.Have a history of heart disease
2.Are taking oral medications regularly
3.Have a history of psychiatric illness
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Futakawa |
Organization
University of Toyama
Division name
Maternity Nursing of Medicine Academic Assembly
Zip code
930-0194
Address
2630 Sugitani, Toyama-shi, 930-0194, Japan
TEL
076-434-7436
kaf0415@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Kaori |
| Middle name | |
| Last name | Futakawa |
Organization
University of Toyama
Division name
Maternity Nursing of Medicine Academic Assembly
Zip code
930-0194
Address
2630 Sugitani, Toyama-shi, 930-0194, Japan
TEL
076-434-7436
Homepage URL
kaf0415@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee on Clinical and Epidemiological Research, University of Toyama
Address
2630 Sugitani, Toyama-shi, 930-0194, Japan
Tel
076-415-8857
rinri@adm.u-toyama.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
| 2025 | Year | 02 | 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
| 2025 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 03 | Day |
Last modified on
| 2026 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065044
