UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013837 |
|---|---|
| Receipt number | R000016132 |
| Scientific Title | Skin-moisturizing Effects of Foot bathing Combined with Warm Compress Therapy |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2015/04/14 12:04:37 |
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Basic information
Public title
Skin-moisturizing Effects of Foot bathing Combined with Warm Compress Therapy
Acronym
Skin-moisturizing Effects of Foot bathing Combined with Warm Compress Therapy
Scientific Title
Skin-moisturizing Effects of Foot bathing Combined with Warm Compress Therapy
Scientific Title:Acronym
Skin-moisturizing Effects of Foot bathing Combined with Warm Compress Therapy
Region
| Japan |
Condition
Condition
Those in whom the pathological or treatment condition prevents bathing, consequently causing dry skin
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of foot bathing combined with warm compress therapy to prevent water loss from the stratum corneum and effectively moisturize the skin by comparing skin blood flow, surface temperature, and moisture content, as well as transepidermal water loss, between 2 groups: those undergoing foot bathing at a water temperature of 41C; and those undergoing such foot bathing with a warm compress.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
> Increased skin blood flow
> Increased skin surface temperature
> Increased skin moisture content
> Reduced transepidermal water loss
Foot bathing combined with warm compress therapy may promote skin blood flow by dilating blood vessels in the skin, consequently increasing the water content of the stratum corneum. It may also contribute to skin surface moisturizing by preventing transepidermal water loss and retaining water content of the stratum corneum
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Method A (foot bathing only)
Foot bathing: Preparing 13 L of water at 41C, and placing the right foot in it for 10 minutes
=> Method B (foot bathing with warm compress therapy)
Interventions/Control_2
Method B (foot bathing with warm compress therapy)
Foot bathing: Preparing 13 L of water at 41C, and placing the right foot in it for 10 minutes
Warm compress therapy: Applying a warm compress (Kao Corporation) to the lower back during foot bathing
=> Method A (foot bathing only)
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
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy female university students
Key exclusion criteria
Those with skin diseases, such as atopic dermatitis, heat-related eczema or urticarial, or wounds or itching sensations in the lower limbs, or those currently taking oral
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimiyo Yamanaki |
Organization
Kio University Graduate School of Health Science
Division name
Nursing Education
Zip code
Address
4-2-2Umami-nakaKoryo-cho,
TEL
0745-54-1601
H1371024@kio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimiyo Yamanaki |
Organization
Kio University Graduate School of Health Science
Division name
Nursing Education
Zip code
Address
4-2-2Umami-naka Koryo-cho,
TEL
0745-54-1601
Homepage URL
H1371024@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio 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
Address
Tel
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
| 2014 | Year | 06 | Month | 01 | 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
| 2014 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 28 | Day |
Last modified on
| 2015 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016132
