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

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 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


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

Value
https://center6.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