UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049602 |
|---|---|
| Receipt number | R000056492 |
| Scientific Title | Physiological changes in the foot with hot moist compress. - A comparison study with footbaths- |
| Date of disclosure of the study information | 2022/11/24 |
| Last modified on | 2023/11/25 18:35:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of hot moist compresses applied to feet of healthy university students. -A comparison with footbaths-
Acronym
Effects of hot moist compresses applied to feet. -A comparison with footbaths-
Scientific Title
Physiological changes in the foot with hot moist compress. - A comparison study with footbaths-
Scientific Title:Acronym
Physiological changes in the foot with hot moist compress.
Region
| Japan |
Condition
Condition
Healthy university students with no disease
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the difference in physiological changes between hot moist compresses and footbaths.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Deep Temperature
Key secondary outcomes
Time to open eyes and stand on one leg
Toe grip
Dorsal flexion angle of the ankle joint
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
1.observation
2.footbaths
3. washout period;1 day or more
4.hot moist compresses
5.observation
Interventions/Control_2
1.observation
2.hot moist compresses
3. washout period;1 day or more
4.footbathshot moist compresses
5.observation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy university students who agreed to participate this study
Key exclusion criteria
1.Persons suffering from neurological, bone, or joint diseases that significantly affect standing.
2.Those with inflammation, hemorrhage, or irritative symptoms due to pain, for which the hot compresses are contraindicated. Are not allowed to participate in the study even then meeting the inclusion criteria.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Harumi |
| Middle name | |
| Last name | Kouri |
Organization
Miyazaki Prefectural Nursing University
Division name
School of Nursing Department of Nursing
Zip code
880-0929
Address
3-5-1, Manabino,Miyazaki-city, Miyazaki
TEL
0985-59-7741
kohri@mpu.ac.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Tanaka |
Organization
Miyazaki Prefectural Nursing University
Division name
School of Nursing Department of Nursing
Zip code
880-0929
Address
3-5-1, Manabino,Miyazaki-city,Miyazaki
TEL
0985-59-7700
Homepage URL
michiko-ta@mpu.ac.jp
Sponsor or person
Institute
Miyazaki Prefectural Nursing University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Research Ethics Committee, Miyazaki Prefectural Nursing University
Address
3-5-1, Manabino,Miyazaki-city,Miyazaki
Tel
0985-59-7700
yuasa3@mpu.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
宮崎県立看護大学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | 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
26
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
| 2022 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 20 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 10 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 24 | Day |
Last modified on
| 2023 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056492
