UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013837
Receipt No. 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

* 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 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
Email 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
Email H1371024@kio.ac.jp

Sponsor
Institute Kio University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016132

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.